Clinical trial NCT01514188
Conditions: Metastatic Soft Tissue Sarcoma Locally Advanced Soft Tissue Sarcoma Unresectable Soft Tissue Sarcoma
Keywords: sarcoma soft-tissue sarcoma Metastatic,locally advanced, or unresectable soft tissue sarcoma
Sponsor: ImmunityBio, Inc.
Start date: 2012-01-11; Completion date: 2014-12-15
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 2b, randomized, open-label, prospective, multicenter study comparing treatment with INNO 206 to doxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy except potentially as adjuvant or neoadjuvant chemotherapy, and no evidence of tumor recurrence has occurred for at least 12 months.

Detailed description:
One hundred five subjects will be enrolled and randomized 2:1 to receive either INNO-206 or doxorubicin. INNO-206 at a dosage of 350 mg/m2 (doxorubicin equivalents of 260 mg/m2) will be administered as a 30 minute IVI on Day 1 of each cycle to approximately 70 subjects. Doxorubicin (75 mg/m2) will be administered to approximately 35 subjects on Day 1 of each cycle. An individual cycle of therapy will be defined as a 3-week (21-day) period. Cycles will be repeated every 3 weeks. Multiple cycles may be administered until the subject is withdrawn from therapy or until a maximum of 6 cycles are administered. Overall response rates as well as individual categories of response (CR, PR, SD, and PD) will be determined using RECIST 1.1.\[28\] Time-to-event endpoints, including PFS and OS will be assessed using the Kaplan Meier method.\[30\] Evaluation of 4- and 6-month progression-free survival will also be performed. Toxicity (adverse events) will be recorded using the NCI CTCAE, version 4.0 (published 28 May 2009).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: INNO-206 intervention 2: Doxorubicin
Intervention descriptions: intervention 1: INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles intervention 2: Doxorubicin administered at 75 mg/m2 for up to 6 consecutive cycles.

Protocol documents:
Prot_SAP_000.pdf: 
TITLE: 
PROTOCOL NUMBER: 
STUDY DRUG: 
IND NUMBER: 
EUDRACT NUMBER: 
SPONSOR: 
SAFETY HOTLINE: 
SAFETY FAX: 
DATE OF PROTOCOL: 
CLINICAL PROTOCOL 
A Multicenter, Randomized, Open-Label Phase 
2b Study to Investigate the Preliminary 
Efficacy and Safety of INN0-206 (Doxorubicin-
EMCH) Compared to Doxorubicin in Subjects 
with Metastatic, Locally Advanced, or 
Unresectable Soft Tissue Sarcoma 
INN0-206-P2-STS-01 
INN0-206 
113,695 
2011-004927-11 
CytRx Corporation 
11726 San Vicente Blvd 
Los Angeles, CA 90049 
(310) 826-5648 
FAX: (310) 826-6139 
Toll-free: 1-877-462-0134 
Toll-free: 1-877-464-7787 
November 14, 2011 
CONFIDENTIAL 
The information contained in this document is confidential and the proprietary property of CytRx 
Corporation. Any unauthorized use or disclosure of such information without the prior written 
authorization of CytRx Corporation is prohibited. 


INN0-206-P2-STS-01 
November 14 2011 
PROTOCOL SIGNATURE PAGE 
A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the 
Preliminary Efficacy and Safety of INN0-206 (Doxorubicin-EMCH) Compared to 
Doxorubicin in Subjects with Metastatic, Locally Advanced, or Unresectable 
Soft Tissue Sarcoma 
By signing below, the Investigator agrees to adhere to the protocol as outlined and agrees 
that any changes to the protocol must be approved by CytRx Corporation prior to seeking 
approval from the Institutional Review Board (IRB)/lndependent Ethics Committee (IEC). 
The study will be conducted in accordance with current United States (US) Food and Drug 
Administration (FDA) regulations, International Conference on Harmonization (ICH) 
guidelines, Good Clinical Practice (GCP) guidelines, the principles of the Declaration of 
Helsinki, and other applicable regulations and guidelines. 
Investigator's Signature:-----------------
Printed Name:--------------------
Name of Institution/Company:--------------
Date: -----------------------
Sponsor Signature: __ 
__ U 
__ 
Daniel Levitt, M.D., Ph.D. 
Chief Medical Officer 
CytRx Corporation 
Date: __ !() 
__ 
_)e>_{_/ _______ _ 
CytRx Corporation 
CONFIDENTIAL 
Page ii 


INN0-206-P2-STS-01 
November 14 2011 
1. 
SYNOPSIS 
Name of Sponsor/Company: CytRx Corporation 
Protocol Number: 
Phase of Development: 2b 
INN0-206-P2-STS-01 
Title of the Protocol: 
A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and 
Safety of INN0-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects with Metastatic, 
Locally Advanced, or Unresectable Soft Tissue Sarcoma 
Primary Objectives: 
The primary objective of this study is to determine the preliminary efficacy of administration of INNO-
206 compared to doxorubicin in subjects with metastatic, locally advanced, or unresectable soft 
tissue sarcoma as measured by progression-free survival, progression-free survival at 3 and 6 
months, tumor response and overall survival. 
Secondary Objectives: 
The secondary objective of this study is to evaluate the safety of INN0-206 compared to doxorubicin 
in this population assessed by the frequency and severity of adverse events (AEs), abnormal findings 
on physical examination, laboratory tests, vital signs, multiple-gated acquisition (MUGA) 
scans/cardiac ultrasound evaluations, electrocardiogram (ECG) results, and weight. 
Study Rationale and Significance: 
INN0-206 is a novel prodrug that binds covalently to albumin in the circulation. The drug is 
accumulated in tumors and doxorubicin is released in the tumor by cleaving the acid labile linker 
(EMCH) in the low pH tumor environment. This carrier-linked prod rug has demonstrated enhanced 
anti-tumor activity with reduced toxicity in several murine models when compared with free 
doxorubicin. 
Patients with metastatic, locally advanced, or unresectable soft tissue sarcomas have a poor 
prognosis with progression-free survival of around 4-5 months and median overall survival of 
approximately 15 months. Three-year survival rates as high as 30% have been observed in some 
clinical studies. Several chemotherapy regimens have been explored as palliative therapy for 
subjects with advanced soft tissue sarcomas. Combinations of ifosfamide and doxorubicin appear to 
offer the highest response rates and longest time to progression. However, these regimens are quite 
toxic and have not significantly increased survival in these individuals. INN0-206 may improve the 
activity of doxorubicin without increasing its toxicity as has been demonstrated in animal studies. 
CytRx Corporation 
CONFIDENTIAL 
Page Iii 


INN0-206-P2-STS-01 
November 14 2011 
Name of Sponsor/Company: CytRx Corporation 
Protocol Number: 
Phase of Development: 2b 
I NN0-206-P2-STS-01 
Study Design and Methodology: 
This is a phase 2b open-label study evaluating the preliminary efficacy and safety of INN0-206 
administered at 350 mglm2 (260 mglm2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 
days for up to 6 consecutive cycles compared to doxorubicin administered at 75 mglm2for up to 6 
consecutive cycles, Subjects will be randomized 2: 1 to receive either INN0-206 or doxorubicin, 
Tumor response will be monitored prior to (within 5 days) of Cycles 3 and 6 (then every 2 months for 
8 months, then every 3 months until disease progression) using the Response Evaluation Criteria in 
Solid Tumors (RECIST) 1, 1 criteria, and treatment will continue every 21 days until tumor progression 
is observed, 6 cycles of treatment are completed or unacceptable toxicity occurs, Progression-free 
survival [PFS], progression-free survival at 3 and 6 months and overall survival [OS] will be monitored 
as other primary objectives, Subjects will visit the study site every 21 days for their IV infusions, at 
which time safety monitoring, including AEs, a directed physical examination, laboratory evaluations 
(serum chemistry, complete blood count [CBC], and urinalysis), vital signs, weight measurements, 
ECOG and ECGs will be performed, Cardiac function will also be followed periodically using either 
MUGA scans or cardiac ultrasounds, 
Cy!Rx Corporation 
CONFIDENTIAL 
Page Iv 


INN0-206-P2-STS-01 
November 14 2011 
Name of Sponsor/Company: CytRx Corporation 
Protocol Number: 
Phase of Development: 2b 
INN0-206-P2-STS-01 
Study Population and Main Criteria for Inclusion/Exclusion: 
Inclusion Criteria: 
Subjects must meet the following criteria to be included in the study: 
1. Age between 15 and 80 years (US only), and 18-80 (rest of world (ROW)), male or female. 
2. Adjuvant or neoadjuvant chemotherapy (including doxorubicin) allowed if no tumor recurrence for 
at least 12 months since the last measurement, beginning or end of last chemotherapy. 
3. 
Histologically or cytologically confirmed, locally advanced, unresectable, and/or metastatic soft 
tissue sarcoma of intermediate or high grade. 
4. Capable of providing informed consent and complying with trial procedures. 
5. 
ECOG performance status 0-2. 
6. 
Life expectancy >12 weeks. 
7. 
Measurable tumor lesions according to RECIST 1. 1 criteria. 
8. Women must not be able to become pregnant (eg post menopausal for at least 1 year, surgically 
sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate 
contraception includes: oral contraception, implanted contraception, intrauterine device implanted 
for at least 3 months, or barrier method in conjunction with spermicide.) 
9. 
Women of child bearing potential must have a negative serum or urine pregnancy test at the 
Screening Visit and be non-lactating. 
10. Geographic accessibility to the site that ensures the subject will be able to keep all study-related 
appointments. 
Exclusion Criteria: 
Subjects meeting the following criteria will not be enrolled: 
1. Prior chemotherapy unless for adjuvant or neoadjuvant therapy with no tumor recurrence for at 
least 12 months. 
2. 
Prior exposure to >3 cycles or 225 mg/m2 of doxorubicin or Doxii®. 
3. Palliative surgery and/or radiation treatment less than 4 weeks prior to Randomization. 
4. 
Exposure to any investigational agent within 30 days of Randomization. 
5. Current Stage 1 or 2 soft tissue sarcomas. 
6. Current evidence/diagnosis of alveolar soft part sarcoma, chondrosarcoma, rhabdomyosarcoma, 
osteosarcoma, gastrointestinal stromal tumor (GIST), dermatofibrosarcoma, Ewing's sarcoma, 
Kaposi's sarcoma, mixed mesodermal tumor, radiation-induced sarcomas and unresectable low 
grade liposarcomas. 
7. 
Evidence of central nervous system (CNS) metastasis (negative imaging study within 4 weeks of 
Screening Visit or during Screening). 
8. 
History of other malignancies except cured basal cell carcinoma, superficial bladder cancer or 
carcinoma in situ of the cervix unless documented free of cancer for ,::5 years. 
9. 
Laboratory values: Screening serum creatinine >1.5x upper limit of normal (ULN), alanine 
aminotransferase (ALT) > 3 x ULN or >5 x ULN if liver metastases are present, total bilirubin >3 x 
ULN, absolute neutrophil count <1,500/mm3, platelet concentration <100,000/mm3, hematocrit 
level <25% for females or <27% for males, or coagulation tests (prothrombin time [PT], partial 
thromboplastin time [PTT], International Normalized Ratio [INR]) >1.5 x ULN, albumin <2.0 g/dL 
10. Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) 
guidelines. 
CytRx Corporation 
CONFIDENTIAL 
Pagev 


INN0-206-P2-STS-01 
November 14 2011 
Name of Sponsor/Company: CytRx Corporation 
Protocol Number: 
Phase of Development: 2b 
INN0-206-P2-STS-01 
11. Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute 
arrhythmia or ventricular arrhythmias classified as Lown Ill, IV or V. 
12. Baseline QTc >470 msec and/or previous history of QT prolongation while taking other 
medications. Concomitant use of medications associated with a high incidence of QT 
prolongation is not allowed 
13. History or signs of active coronary artery disease with or without angina pectoris. 
14. Serious myocardial dysfunction defined as scintigraphically (eg MUGA, myocardial scintigram) or 
ultrasound determined absolute left ventricular ejection fraction (LVEF) <45% of predicted. 
15. History of HIV infection. 
16. Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-
fungals. 
17. Major surgery within 3 weeks prior to Randomization. 
18. Substance abuse or any condition that might interfere with the subject's participation in the study 
or in the evaluation of the study results. 
19. Any condition that is unstable and could jeopardize the subject's participation in the study. 
Number of Subjects: 
One hundred and five (105) study subjects will be randomized 2:1 (INN0-206:doxorubicin) at 
approximately 30 study centers in the United States (US), Hungary, Romania, Ukraine, Russia, India, 
and Australia. Up to 32 subjects may be enrolled in India, with the remaining subjects distributed in 
the other locations. 
Test Product, Dose and Mode of Administration: 
Lyophilized powder in vials that contain 200 mg of INN0-206 reconstituted by adding a sterile solution 
of 50% ethanol: 50% water, administration completed within 2 hours (of being reconstituted) as a 30 
minute IV infusion in Lactated Ringer's solution. Total dose of 350 mg/m2 (260 mg/m2 doxorubicin 
equivalent). 
Reference Therapy, Dose and Mode of Administration: 
Doxorubicin HCI Injection is a sterile parenteral, isotonic available in 5 ml (10 mg), 10 ml (20 mg), 25 
ml (50 mg) single dose vials. Each ml contains doxorubicin HCI and the following inactive 
ingredients: NaCl (0.9%) and water for injection q.s. Hydrochloric acid is used to adjust the pH to a 
target of pH of 3.0. Prepare IV infusion per the package insert (see the Study Reference Manual). 
Criteria for Evaluation: 
Efficacy: 
The following efficacy variables will be evaluated as noted: 
• 
Progression-free survival 
• 
Overall survival 
• 
Objective tumor response (RECIST 1.1 criteria) 
• 
3 and 6 month progression-free survival 
Safety: 
The following safety variables will be assessed over 16 weeks: 
• 
Adverse events 
• 
Ability to remain on assigned treatment (tolerability) 
• 
Clinical and laboratory data including physical examinations, vital signs, weight, 
MUGA/cardiac ultrasound evaluations, ECG results and laboratory test results 
• 
Use of concomitant medications 
Cy!Rx Corporation 
CONFIDENTIAL 
Page vi 


INN0-206-P2-STS-01 
November 14 2011 
Name of Sponsor/Company: CytRx Corporation 
Protocol Number: 
Phase of Development: 2b 
INN0-206-P2-STS-01 
Statistical Methods: 
In accordance with the intention-to-treat principle, all randomized subjects who enter active treatment 
and have had at least 1 dose of study medication and 1 post-dose efficacy measurement will be 
included in the primary statistical analyses according to the treatment group to which they were 
originally assigned. 
Efficacy: 
Tumor response will be monitored prior to Cycle 3 and 6 as well as every 2 months for 8 months from 
randomization, then every 3 months until disease progression. For the estimation of progression-free 
and overall survival a Kaplan-Meier analysis will be performed. The percentage of subjects with 
complete or partial responses, or stable disease will be evaluated at 3 and 6 months. 
Safety: 
The safety data will be summarized by treatment group. The treatment groups will be compared with 
respect to occurrence of each AE. Total number of AEs leading to withdrawal, and abnormal 
laboratory tests will be compared between groups using Fisher's exact test. Adverse events, ability to 
remain on assigned treatment (tolerability), and abnormal findings on physical examinations, vital 
signs, weight, ECG results, laboratory test results, and use of concomitant medications, will be 
assessed to characterize the safety profile of the treatment regimens. Descriptive statistics denoting 
the changes from baseline to the final assessment visit with respect to key laboratory parameters and 
vital signs will also be provided. 
CytRx Corporation 
CONFIDENTIAL 
Page vii 


INN0-206-P2-STS-01 
November 14, 2011 
APPENDIX A: 
Schedule of Treatment and Evaluations 
Screening 
End of 
Every 
Follow 
-21 Days 
Cycle 1 
Cycle2 
Cycle3 
Cycle4 
Cycles 
Cycle6 
Treatment17 
2 or3 mo.16 
Up14 
Signed informed consent 
x 
Review inclusion/exclusion 
x 
x 
Medical history1 
x 
Physical examination 
x 
x 
x 
x 
x 
x 
x 
X" 
x 
Height (cm) 
x 
Weight (kg) 
x 
x 
x 
x 
x 
x 
x 
BSA calculation2 
x 
x 
x 
x 
x 
x 
Vital signs3 
x 
x 
x 
x 
x 
x 
x 
x 
ECOGPS 
x 
x 
x 
x 
x 
x 
x 
x 
CT/ MRI scan I tumor measurements4 
x' 
X' 
X' 
X" 
X' 
Chest x-ray 
X" 
x10.12 
Bone scan or PET/CT 
x" 
ECG 
x 
x 
x 
x 
x 
x 
x 
X" 
x 
ECHO (wtth ejection fraction) or 
x 
x 
x 
x 
x 
x 
MUGA/cardiac ultrasound 
CBC w/dlfferential & pits' 
x 
X" 
x 
x 
x 
x 
x 
x" 
x 
Serum chemistries5·6 
x 
X'° 
x 
x 
x 
x 
x 
X" 
Urinalysis7 
x 
X" 
Serum troponin 
x 
X" 
x 
x 
x 
x 
x 
x" 
x 
Serum/urine pregnancy test 
x 
Randomization 
X" 
INN0-206 or doxorubicin admin 
x 
x 
x 
x 
x 
x 
administration21 
Blood alcohol level"' 
Concomitant medications 
X" 
x 
x 
x 
x 
x 
x 
x 
Adverse events 
x 
x 
x 
x 
x 
x 
x 
x 
Telephone call 
x 
NOTE: All assessments must be performed within 72 hr of each specified time parameter, except Cycle 1 (see Section 7 for details). 
CytRx Corporation 
CONFIDENTIAL 
Page49 


CLINICAL PROTOCOL 
TITLE: 
A Multicenter, Randomized, Open-Label Phase 
2b Study to Investigate the Preliminary 
Efficacy and Safety of INNO-206 (Doxorubicin-
EMCH) Compared to Doxorubicin in Subjects 
with Metastatic, Locally Advanced, or 
Unresectable Soft Tissue Sarcoma 
PROTOCOL NUMBER: 
INNO-206-P2-STS-01 
STUDY DRUG: 
INNO-206 
IND NUMBER: 
113,695 
EUDRACT NUMBER: 
2011-004927-11 
SPONSOR:  
CytRx Corporation 
11726 San Vicente Blvd 
Los Angeles, CA 90049 
(310) 826-5648
FAX: (310) 826-6139
SAFETY HOTLINE: 
Toll-free: 1-877-462-0134 
SAFETY FAX: 
Toll-free: 1-877-464-7787 
DATE OF PROTOCOL: 
November 14, 2011 
AMENDMENT 1: 
December 16, 2011 
CONFIDENTIAL 
The information contained in this document is confidential and the proprietary property of CytRx 
Corporation. Any unauthorized use or disclosure of such information without the prior written 
authorization of CytRx Corporation is prohibited. 




INNO-206-P2-STS-01 Amendment 1                         
December 16, 2011 
 
CytRx Corporation 
CONFIDENTIAL 
Page iii 
1. 
SYNOPSIS 
Name of Sponsor/Company: CytRx Corporation
 
Protocol Number: 
INNO-206-P2-STS-01 
 
Phase of Development: 2b
 
Title of the Protocol: 
A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and 
Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects with Metastatic, 
Locally Advanced, or Unresectable Soft Tissue Sarcoma 
Primary Objectives:
The primary objective of this study is to determine the preliminary efficacy of administration of INNO-
206 compared to doxorubicin in subjects with metastatic, locally advanced,  or unresectable soft 
tissue sarcoma as measured by progression-free survival, progression-free survival at 4 and 6 
months, tumor response and overall survival. 
Secondary Objectives: 
The secondary objective of this study is to evaluate the safety of INNO-206 compared to doxorubicin 
in this population assessed by the frequency and severity of adverse events (AEs), abnormal findings 
on physical examination, laboratory tests, vital signs, multiple-gated acquisition (MUGA) 
scans/cardiac ultrasound evaluations, electrocardiogram (ECG) results, and weight. 
Study Rationale and Significance: 
INNO-206 is a novel prodrug that binds covalently to albumin in the circulation. The drug is 
accumulated in tumors and doxorubicin is released in the tumor by cleaving the acid labile linker 
(EMCH) in the low pH tumor environment.  This carrier-linked prodrug has demonstrated enhanced 
anti-tumor activity with reduced toxicity in several murine models when compared with free 
doxorubicin. 
Patients with metastatic, locally advanced, or unresectable soft tissue sarcomas have a poor 
prognosis with progression-free survival of around 4-5 months and median overall survival of 
approximately 15 months.  Three-year survival rates as high as 30% have been observed in some 
clinical studies.  Several chemotherapy regimens have been explored as palliative therapy for 
subjects with advanced soft tissue sarcomas. Combinations of ifosfamide and doxorubicin appear to 
offer the highest response rates and longest time to progression.  However, these regimens are quite 
toxic and have not significantly increased survival in these individuals.  INNO-206 may improve the 
activity of doxorubicin without increasing its toxicity as has been demonstrated in animal studies. 


INNO-206-P2-STS-01 Amendment 1                         
December 16, 2011 
 
CytRx Corporation 
CONFIDENTIAL 
Page iv 
Name of Sponsor/Company: CytRx Corporation
 
Protocol Number: 
INNO-206-P2-STS-01 
 
Phase of Development: 2b
 
Study Design and Methodology:
This is a phase 2b open-label study evaluating the preliminary efficacy and safety of INNO-206 
administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent)  intravenously (IV) on Day 1 every 21 
days for up to 6 consecutive cycles compared to doxorubicin administered at 75 mg/m2 for up to 6 
consecutive cycles. Subjects will be randomized 2:1 to receive either INNO-206 or doxorubicin. 
Subjects will visit the study site every 21 days for their IV infusions, at which time safety monitoring, 
including AEs, a directed physical examination, laboratory evaluations (serum chemistry, complete 
blood count [CBC], and urinalysis), vital signs, weight measurements, ECOG and ECGs will be 
performed.  Cardiac function will also be followed periodically using either MUGA scans or cardiac 
ultrasounds. Treatment will continue every 21 days until tumor progression is observed, 6 cycles of 
treatment are completed or unacceptable toxicity occurs.  
Tumor response will be monitored every 60 days (2 months) after Cycle 1-Day 1 until Day 240 (8 
months), then every 3 months until disease progression using the Response Evaluation Criteria in 
Solid Tumors (RECIST) 1.1 criteria, and. Progression-free survival [PFS], progression-free survival at 
4 and 6 months and overall survival [OS] will be monitored as other primary objectives.  
 
 


INNO-206-P2-STS-01 Amendment 1                         
December 16, 2011 
 
CytRx Corporation 
CONFIDENTIAL 
Page v 
Name of Sponsor/Company: CytRx Corporation
 
Protocol Number: 
INNO-206-P2-STS-01 
 
Phase of Development: 2b
 
Study Population and Main Criteria for Inclusion/Exclusion: 
Inclusion Criteria: 
Subjects must meet the following criteria to be included in the study: 
1. Age between 15-80 years (US only), and 18-80 (rest of world (ROW)), male or female. 
2. Adjuvant or neoadjuvant chemotherapy (including doxorubicin) allowed if no tumor recurrence for 
at least 12 months since the last measurement, beginning or end of last chemotherapy. 
3. Histologically or cytologically confirmed, locally advanced, unresectable, and/or metastatic soft 
tissue sarcoma of intermediate or high grade. 
4. Capable of providing informed consent and complying with trial procedures. 
5. ECOG performance status 0-2. 
6. Life expectancy >12 weeks. 
7. Measurable tumor lesions according to RECIST 1.1 criteria. 
8. Women must not be able to become pregnant (eg post-menopausal for at least 1 year, surgically 
sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate 
contraception includes: oral contraception, implanted contraception, intrauterine device implanted 
for at least 3 months, or barrier method in conjunction with spermicide.) 
9. Women of child bearing potential must have a negative serum or urine pregnancy test at the 
Screening Visit and be non-lactating. 
10. Geographic accessibility to the site that ensures the subject will be able to keep all study-related 
appointments. 
Exclusion Criteria: 
Subjects meeting the following criteria will not be enrolled: 
1. Prior chemotherapy unless for adjuvant or neoadjuvant therapy with no tumor recurrence for at 
least 12 months.  
2. Prior exposure to >3 cycles or 225 mg/m2 of doxorubicin or Doxil®. 
3. Palliative surgery and/or radiation treatment less than 4 weeks prior to Randomization. 
4. Exposure to any investigational agent within 30 days of Randomization. 
5. Current Stage 1 or 2 soft tissue sarcomas. 
6. Current evidence/diagnosis of alveolar soft part sarcoma, chondrosarcoma, rhabdomyosarcoma, 
osteosarcoma, gastrointestinal stromal tumor (GIST), dermatofibrosarcoma, Ewing’s sarcoma, 
Kaposi’s sarcoma, mixed mesodermal tumor, clear cell sarcomas and unresectable low grade 
liposarcomas. 
7. Central nervous system metastasis  
8. History of other malignancies except cured basal cell carcinoma, superficial bladder cancer or 
carcinoma in situ of the cervix unless documented free of cancer for >5 years. 
9. Laboratory values: Screening serum creatinine >1.5x upper limit of normal (ULN), alanine 
aminotransferase (ALT) > 3 × ULN or >5 × ULN if liver metastases are present, total bilirubin >3 × 
ULN, absolute neutrophil count <1,500/mm3, platelet concentration <100,000/mm3, hematocrit 
level <25% for females or <27% for males, or coagulation tests (prothrombin time [PT], partial 
thromboplastin time [PTT], International Normalized Ratio [INR]) >1.5 × ULN, albumin <2.0 g/dL. 
10. Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) 
guidelines. 


INNO-206-P2-STS-01 Amendment 1                         
December 16, 2011 
 
CytRx Corporation 
CONFIDENTIAL 
Page vi 
Name of Sponsor/Company: CytRx Corporation
 
Protocol Number: 
INNO-206-P2-STS-01 
 
Phase of Development: 2b
 
11. Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute 
arrhythmia or ventricular arrhythmias classified as Lown III, IV or V. 
12. Baseline QTc >470 msec and/or previous history of QT prolongation while taking other 
medications. Concomitant use of medications associated with a high incidence of QT 
prolongation is not allowed 
13. History or signs of active coronary artery disease with or without angina pectoris. 
14. Serious myocardial dysfunction defined as scintigraphically (eg MUGA, myocardial scintigram) or 
ultrasound determined absolute left ventricular ejection fraction (LVEF) <45% of predicted. 
15. History of HIV infection. 
16. Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-
fungals. 
17. Major surgery within 3 weeks prior to Randomization. 
18. Substance abuse or any condition that might interfere with the subject’s participation in the study 
or in the evaluation of the study results. 
19. Any condition that is unstable and could jeopardize the subject’s participation in the study. 
Number of Subjects:
One hundred and five (105) study subjects will be randomized 2:1 (INNO-206:doxorubicin) at 
approximately 30 study centers in the United States (US), Hungary, Romania, Ukraine, Russia, India, 
and Australia. Up to 32 subjects may be enrolled in India, with the remaining subjects distributed in 
the other locations. 
Test Product, Dose and Mode of Administration:
Lyophilized powder in vials that contain 200 mg of INNO-206 reconstituted by adding a sterile solution 
of 50% ethanol: 50% water, administration completed within 2 hours (of being reconstituted) as a 30 
minute IV infusion in Lactated Ringer’s solution.  Total dose of 350 mg/m2 (260 mg/m2 doxorubicin 
equivalent). 
Reference Therapy, Dose and Mode of Administration:
Doxorubicin HCl Injection is a sterile parenteral, isotonic available in 5 mL (10 mg), 10 mL (20 mg), 25 
mL (50 mg) single dose vials.  Each mL contains doxorubicin HCl and the following inactive 
ingredients: NaCl (0.9%) and water for injection q.s.  Hydrochloric acid is used to adjust the pH to a 
target of pH of 3.0.  Prepare IV infusion per the package insert (see the Study Reference Manual). 
Criteria for Evaluation:
Efficacy: 
The following efficacy variables will be evaluated as noted: 
 
Progression-free survival 
 
Overall survival 
 
Objective tumor response (RECIST 1.1 criteria) 
 
4 and 6 month progression-free survival 
Safety:
The following safety variables will be assessed over the duration of the study: 
 
Adverse events 
 
Ability to remain on assigned treatment (tolerability) 
 
Clinical and laboratory data including physical examinations, vital signs, weight, 
MUGA/cardiac ultrasound evaluations, ECG results and laboratory test results 
 
Use of concomitant medications 


INNO-206-P2-STS-01 Amendment 1                         
December 16, 2011 
 
CytRx Corporation 
CONFIDENTIAL 
Page vii 
Name of Sponsor/Company: CytRx Corporation
 
Protocol Number: 
INNO-206-P2-STS-01 
 
Phase of Development: 2b
 
Statistical Methods: 
In accordance with the intention-to-treat principle, all randomized subjects who enter active treatment 
and have had at least 1 dose of study medication and 1 post-dose efficacy measurement will be 
included in the primary statistical analyses according to the treatment group to which they were 
originally assigned.   
Efficacy:   
Tumor response will be monitored every 60 days (2 months) after Cycle 1-Day 1 until Day 240 (8 
months) from first drug application (within 5 days of given time point), then every 3 months until 
disease progression. For the estimation of progression-free and overall survival a Kaplan-Meier 
analysis will be performed.  The percentage of subjects with complete or partial responses, or stable 
disease will be evaluated at 4 and 6 months. 
Safety:  
The safety data will be summarized by treatment group.  The treatment groups will be compared with 
respect to occurrence of each AE. Total number of AEs leading to withdrawal, and abnormal 
laboratory tests will be compared between groups using Fisher’s exact test. Adverse events, ability to 
remain on assigned treatment (tolerability), and abnormal findings on physical examinations, vital 
signs, weight, ECG results, laboratory test results, and use of concomitant medications, will be 
assessed to characterize the safety profile of the treatment regimens. Descriptive statistics denoting 
the changes from baseline to the final assessment visit with respect to key laboratory parameters and 
vital signs will also be provided. 


INNO-206-P2-STS-01 Amendment 1 
December 16, 2011 
 
CytRx Corporation 
CONFIDENTIAL 
Page 49 
APPENDIX A: Schedule of Treatment and Evaluations 
 
Screening
-21 Days 
Cycle 1 
Cycle 2 
Cycle 3 
Cycle 4 
Cycle 5 
Cycle 6 
End of 
Treatment
14 
Every 
2 or 3 mo.
13 
Follow Up
12 
Signed informed consent 
X 
 
 
 
 
 
 
 
 
 
Review inclusion/exclusion 
X 
X 
 
 
 
 
 
 
 
 
Medical history
1 
X 
 
 
 
 
 
 
 
 
 
Physical examination 
X 
X 
X 
X 
X 
X 
X 
X
16 
X 
 
Height (cm) 
X 
 
 
 
 
 
 
 
 
 
Weight (kg) 
X 
X 
X 
X 
X 
X 
X 
 
 
 
BSA calculation
2 
 
X 
X 
X 
X 
X 
X 
 
 
 
Vital signs
3 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
ECOG PS 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
CT/ MRI scan / tumor measurements
4 
X
8a 
 
 
X
8 
 
 
X
8 
X
10 
X
8 
 
ECG 
X 
X 
X 
X 
X 
X 
X 
X
11 
X 
 
ECHO (with ejection fraction) or 
MUGA/cardiac ultrasound 
X 
 
X 
 
X 
 
X 
X 
X 
 
CBC w/differential & plts
5 
X 
X
16 
X 
X 
X 
X 
X 
X
11 
X 
 
Serum chemistries
 5, 6 
X 
X
16 
X 
X 
X 
X 
X 
X
11 
 
 
Urinalysis
7 
X 
 
 
 
 
 
 
X
11 
 
 
Serum troponin 
X 
X
16 
X 
X 
X 
X 
X 
X
11 
X 
 
Serum/urine pregnancy test 
X 
 
 
 
 
 
 
 
 
 
Randomization 
 
X
15 
 
 
 
 
 
 
 
 
INNO-206 or doxorubicin admin 
administration
17 
 
X 
X 
X 
X 
X 
X 
 
 
 
Blood alcohol level
18 
 
X 
X 
X 
X 
X 
X 
 
 
 
Concomitant medications 
X
9 
X 
X 
X 
X 
X 
X 
X 
 
 
Adverse events 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Telephone call 
 
 
 
 
 
 
 
 
 
X 
NOTE: All assessments must be performed within 72 hr of each specified time parameter, except Cycle 1 (see Section 7 for details). 


CLINICAL PROTOCOL 
TITLE: 
A Multicenter, Randomized, Open-Label Phase 
2b Study to Investigate the Preliminary 
Efficacy and Safety of INNO-206 (Doxorubicin-
EMCH) Compared to Doxorubicin in Subjects 
with Metastatic, Locally Advanced, or 
Unresectable Soft Tissue Sarcoma 
PROTOCOL NUMBER: 
INNO-206-P2-STS-01 
STUDY DRUG: 
INNO-206 
IND NUMBER: 
113,695 
EUDRACT NUMBER: 
2011-004927-11 
SPONSOR:  
CytRx Corporation 
11726 San Vicente Blvd 
Los Angeles, CA 90049 
(310) 826-5648
FAX: (310) 826-6139
SAFETY HOTLINE: 
Toll-free: 1-877-462-0134 
SAFETY FAX: 
Toll-free: 1-877-464-7787 
DATE OF PROTOCOL: 
November 14, 2011 
AMENDMENT 1: 
December 16, 2011 
AMENDMENT 2: 
April 15, 2012 
CONFIDENTIAL 
The information contained in this document is confidential and the proprietary property of CytRx 
Corporation. Any unauthorized use or disclosure of such information without the prior written 
authorization of CytRx Corporation is prohibited. 


INNQ-206-P2-STS-01 Amendment 2 
Aprll 15. 2012 
PROTOCOL SIGNATURE PAGE 
A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the 
Preliminary Efficacy and Safety of INN0-206 (Doxorubicin-EMCH) Compared to 
Doxorubicin in Subjects with Metastatic, Locally Advanced, or Unresectable 
Soft Tissue Sarcoma 
By signing below, the Investigator agrees to adhere to the protocol as outlined and agrees 
that any changes to the protocol must be approved by CytRx Corporation prior to seeking 
approval from the Institutional Review Board (IRB)/lndependent Ethics Committee (IEC). 
The study will be conducted in accordance with current United States (US) Food and Drug 
Administration (FDA) regulations, International Conference on Harmonization (ICH) 
guidelines, Good Clinical Practice (GCP) guidelines, the principles of the Declaration of 
Helsinki, and other applicable regulations and guidelines. 
Investigator's Signature: ----------------
-
Printed Name:---------------------
Name of Institution/Company: ---------------
Date: _______________________ _ 
Sponsor Signature: _
_
_ Q 
___ 
..... 
JJ
"""
. '---
Daniel Levitt, M.D., Ph.D. 
Chief Medical Officer 
CytRx Corporation 
[75', l..o (2-
Date: __ 
__ 
CytRx Corporation 
CONFIDENTIAL 
Page ii 


INNO-206-P2-STS-01 Amendment 2                         
April 15, 2012 
 
CytRx Corporation 
CONFIDENTIAL 
Page iii 
1. 
SYNOPSIS 
Name of Sponsor/Company: CytRx Corporation 
 
Protocol Number:  
INNO-206-P2-STS-01 
 
Phase of Development: 2b 
 
Title of the Protocol:  
A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and 
Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects with Metastatic, 
Locally Advanced, or Unresectable Soft Tissue Sarcoma 
Primary Objectives: 
The primary objective of this study is to determine the preliminary efficacy of administration of INNO-
206 compared to doxorubicin in subjects with metastatic, locally advanced,  or unresectable soft 
tissue sarcoma as measured by progression-free survival, progression-free survival at 4 and 6 
months, tumor response and overall survival. 
Secondary Objectives: 
The secondary objective of this study is to evaluate the safety of INNO-206 compared to doxorubicin 
in this population assessed by the frequency and severity of adverse events (AEs), abnormal findings 
on physical examination, laboratory tests, vital signs, multiple-gated acquisition (MUGA) 
scans/cardiac ultrasound evaluations, electrocardiogram (ECG) results, and weight. 
Study Rationale and Significance: 
INNO-206 is a novel prodrug that binds covalently to albumin in the circulation. The drug is 
accumulated in tumors and doxorubicin is released in the tumor by cleaving the acid labile linker 
(EMCH) in the low pH tumor environment.  This carrier-linked prodrug has demonstrated enhanced 
anti-tumor activity with reduced toxicity in several murine models when compared with free 
doxorubicin. 
Patients with metastatic, locally advanced, or unresectable soft tissue sarcomas have a poor 
prognosis with progression-free survival of around 4-5 months and median overall survival of 
approximately 15 months.  Three-year survival rates as high as 30% have been observed in some 
clinical studies.  Several chemotherapy regimens have been explored as palliative therapy for 
subjects with advanced soft tissue sarcomas. Combinations of ifosfamide and doxorubicin appear to 
offer the highest response rates and longest time to progression.  However, these regimens are quite 
toxic and have not significantly increased survival in these individuals.  INNO-206 may improve the 
activity of doxorubicin without increasing its toxicity as has been demonstrated in animal studies. 


INNO-206-P2-STS-01 Amendment 2                         
April 15, 2012 
 
CytRx Corporation 
CONFIDENTIAL 
Page iv 
Name of Sponsor/Company: CytRx Corporation 
 
Protocol Number:  
INNO-206-P2-STS-01 
 
Phase of Development: 2b 
 
Study Design and Methodology: 
This is a phase 2b open-label study evaluating the preliminary efficacy and safety of INNO-206 
administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent)  intravenously (IV) on Day 1 every 21 
days for up to 6 consecutive cycles compared to doxorubicin administered at 75 mg/m2 for up to 6 
consecutive cycles. Subjects will be randomized 2:1 to receive either INNO-206 or doxorubicin. 
Subjects will visit the study site every 21 days for their IV infusions, at which time safety monitoring, 
including AEs, a directed physical examination, laboratory evaluations (serum chemistry, complete 
blood count [CBC], and urinalysis), vital signs, weight measurements, ECOG performance status and 
ECGs will be performed.  Cardiac function will also be followed periodically using either MUGA scans 
or cardiac ultrasounds. Treatment will continue every 21 days until tumor progression is observed, 6 
cycles of treatment are completed or unacceptable toxicity occurs.  
Tumor response will be monitored every 6 weeks from Cycle 1-Day 1 during treatment, at End of 
Treatment, 2 months following the End of Treatment scan (for those subjects completing 6 cycles), 
and then every 3 months until disease progression using the Response Evaluation Criteria in Solid 
Tumors (RECIST) 1.1 criteria.  For those subjects that leave the study prior to completing Cycle 6, 
and who do not start another therapy, they can be followed 2 months following the End of Treatment 
scan, and then every 3 months until disease progression.  However, if a subject receives another 
therapy, they should only be followed for overall survival [OS]. Progression-free survival [PFS], 
progression-free survival at 4 and 6 months and OS will be monitored as other primary objectives.  
 
 


INNO-206-P2-STS-01 Amendment 2                         
April 15, 2012 
 
CytRx Corporation 
CONFIDENTIAL 
Page v 
Name of Sponsor/Company: CytRx Corporation 
 
Protocol Number:  
INNO-206-P2-STS-01 
 
Phase of Development: 2b 
 
Study Population and Main Criteria for Inclusion/Exclusion: 
Inclusion Criteria: 
Subjects must meet the following criteria to be included in the study: 
1. Age between 15-80 years (US only), and 18-80 (rest of world (ROW)), male or female. 
2. Adjuvant or neoadjuvant chemotherapy (including doxorubicin) allowed if no tumor recurrence for 
at least 12 months since the last measurement, beginning or end of last chemotherapy. 
3. Histologically or cytologically confirmed, locally advanced, unresectable, and/or metastatic soft 
tissue sarcoma of intermediate or high grade. 
4. Capable of providing informed consent and complying with trial procedures. 
5. ECOG performance status 0-2. 
6. Life expectancy >12 weeks. 
7. Measurable tumor lesions according to RECIST 1.1 criteria. 
8. Women must not be able to become pregnant (eg post-menopausal for at least 1 year, surgically 
sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate 
contraception includes: oral contraception, implanted contraception, intrauterine device implanted 
for at least 3 months, or barrier method in conjunction with spermicide.) 
9. Women of child bearing potential must have a negative serum or urine pregnancy test at the 
Screening Visit and be non-lactating. 
10. Geographic accessibility to the site that ensures the subject will be able to keep all study-related 
appointments. 
Exclusion Criteria: 
Subjects meeting the following criteria will not be enrolled: 
1. Prior chemotherapy unless for adjuvant or neoadjuvant therapy with no tumor recurrence for at 
least 12 months.  
2. Prior exposure to >3 cycles or 225 mg/m2 of doxorubicin or Doxil®. 
3. Palliative surgery and/or radiation treatment less than 4 weeks prior to Randomization. 
4. Exposure to any investigational agent within 30 days of Randomization. 
5. Current Stage 1 or 2 soft tissue sarcomas. 
6. Current evidence/diagnosis of alveolar soft part sarcoma, chondrosarcoma, rhabdomyosarcoma, 
osteosarcoma, gastrointestinal stromal tumor (GIST), dermatofibrosarcoma, Ewing’s sarcoma, 
Kaposi’s sarcoma, mixed mesodermal tumor, clear cell sarcomas and unresectable low grade 
liposarcomas. 
7. Central nervous system metastasis  
8. History of other malignancies except cured basal cell carcinoma, superficial bladder cancer or 
carcinoma in situ of the cervix unless documented free of cancer for >5 years. 
9. Laboratory values: Screening serum creatinine >1.5x upper limit of normal (ULN), alanine 
aminotransferase (ALT) > 3 × ULN or >5 × ULN if liver metastases are present, total bilirubin >3 × 
ULN, absolute neutrophil count <1,500/mm3, platelet concentration <100,000/mm3, hematocrit 
level <25% for females or <27% for males,  coagulation tests (prothrombin time [PT], partial 
thromboplastin time [PTT], International Normalized Ratio [INR]) >1.5 × ULN, and albumin <2.0 
g/dL. 
10. Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) 
guidelines. 


INNO-206-P2-STS-01 Amendment 2                         
April 15, 2012 
 
CytRx Corporation 
CONFIDENTIAL 
Page vi 
Name of Sponsor/Company: CytRx Corporation 
 
Protocol Number:  
INNO-206-P2-STS-01 
 
Phase of Development: 2b 
 
11. Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute 
arrhythmia or ventricular arrhythmias classified as Lown III, IV or V. 
12. Baseline QTc >470 msec and/or previous history of QT prolongation while taking other 
medications. Concomitant use of medications associated with a high incidence of QT 
prolongation is not allowed 
13. History or signs of active coronary artery disease with or without angina pectoris. 
14. Serious myocardial dysfunction defined as scintigraphically (eg MUGA, myocardial scintigram) or 
ultrasound determined absolute left ventricular ejection fraction (LVEF) <45% of predicted. 
15. History of HIV infection. 
16. Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-
fungals. 
17. Major surgery within 3 weeks prior to Randomization. 
18. Substance abuse or any condition that might interfere with the subject’s participation in the study 
or in the evaluation of the study results. 
19. Any condition that is unstable and could jeopardize the subject’s participation in the study. 
Number of Subjects: 
One hundred and five (105) study subjects will be randomized 2:1 (INNO-206:doxorubicin) at 
approximately 30 study centers in the United States (US), Hungary, Romania, Ukraine, Russia, India, 
and Australia. Up to 32 subjects may be enrolled in India, with the remaining subjects distributed in 
the other locations. 
Test Product, Dose and Mode of Administration: 
Lyophilized powder in vials that contain 200 mg of INNO-206 reconstituted by adding a solution of 
50% ethanol: 50% sterile water, administration completed within 2 hours (of being reconstituted) as a 
30 minute IV infusion in Lactated Ringer’s solution.  Total dose of 350 mg/m2 (260 mg/m2 doxorubicin 
equivalent). 
Reference Therapy, Dose and Mode of Administration: 
Doxorubicin HCl Injection is a sterile parenteral, isotonic available in 5 mL (10 mg), 10 mL (20 mg), 25 
mL (50 mg) single dose vials.  Each mL contains doxorubicin HCl and the following inactive 
ingredients: NaCl (0.9%) and water for injection q.s.  Hydrochloric acid is used to adjust the pH to a 
target of pH of 3.0.  Prepare IV infusion per the package insert (see the Study Reference Manual). 
Criteria for Evaluation: 
Efficacy: 
The following efficacy variables will be evaluated as noted: 
 
Progression-free survival 
 
Overall survival 
 
Objective tumor response (RECIST 1.1 criteria) 
 
4 and 6 month progression-free survival 
Safety: 
The following safety variables will be assessed over the duration of the study: 
 
Adverse events 
 
Ability to remain on assigned treatment (tolerability) 
 
Clinical and laboratory data including physical examinations, vital signs, weight, 
MUGA/cardiac ultrasound evaluations, ECG results and laboratory test results 
 
Use of concomitant medications 


INNO-206-P2-STS-01 Amendment 2                         
April 15, 2012 
 
CytRx Corporation 
CONFIDENTIAL 
Page vii 
Name of Sponsor/Company: CytRx Corporation 
 
Protocol Number:  
INNO-206-P2-STS-01 
 
Phase of Development: 2b 
 
Statistical Methods: 
In accordance with the intention-to-treat principle, all randomized subjects who enter active treatment 
and have had at least 1 dose of study medication and 1 post-dose efficacy measurement will be 
included in the primary statistical analyses according to the treatment group to which they were 
originally assigned.   
Efficacy:   
Tumor response will be monitored every 6 weeks from Cycle 1-Day1 during treatment, at End of 
Treatment, 2 months following the End of Treatment scan (for those subjects completing 6 cycles), 
then every 3 months until disease progression. For the estimation of progression-free and overall 
survival a Kaplan-Meier analysis will be performed.  The percentage of subjects with complete or 
partial responses, or stable disease will be evaluated at 4 and 6 months. 
Safety:  
The safety data will be summarized by treatment group.  The treatment groups will be compared with 
respect to occurrence of each AE. Total number of AEs leading to withdrawal, and abnormal 
laboratory tests will be compared between groups using Fisher’s exact test. Adverse events, ability to 
remain on assigned treatment (tolerability), and abnormal findings on physical examinations, vital 
signs, weight, ECG results, laboratory test results, and use of concomitant medications, will be 
assessed to characterize the safety profile of the treatment regimens. Descriptive statistics denoting 
the changes from baseline to the final assessment visit with respect to key laboratory parameters and 
vital signs will also be provided. 


INNO-206-P2-STS-01 Amendment 2 
April 15, 2012 
 
CytRx Corporation 
CONFIDENTIAL 
Page 49 
APPENDIX A: Schedule of Treatment and Evaluations 
 
Screening 
-21 Days 
Cycle 1 
Cycle 2 
Cycle 3 
Cycle 4 
Cycle 5 
Cycle 6 
End of 
Treatment14 
Every 
2 or 3 mo.13 
Follow Up12 
Signed informed consent 
X 
 
 
 
 
 
 
 
 
 
Review inclusion/exclusion 
X 
X 
 
 
 
 
 
 
 
 
Medical history1 
X 
 
 
 
 
 
 
 
 
 
Physical examination 
X 
X 
X 
X 
X 
X 
X 
X16 
X 
 
Height (cm) 
X 
 
 
 
 
 
 
 
 
 
Weight (kg) 
X 
X 
X 
X 
X 
X 
X 
 
 
 
BSA calculation2 
 
X 
X 
X 
X 
X 
X 
 
 
 
Vital signs3 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
ECOG PS 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
CT/ MRI scan / tumor measurements4 
X8a 
 
 
X8 
 
X8 
 
X10 
X 
 
ECG 
X 
X 
X 
X 
X 
X 
X 
X11 
X 
 
ECHO (with ejection fraction) or 
MUGA/cardiac ultrasound 
X 
 
X 
 
X 
 
X 
X 
X 
 
CBC w/differential & plts5 
X 
X16 
X 
X 
X 
X 
X 
X11 
X 
 
Coagulation tests (PT, PTT, INR) 
X 
 
 
 
 
 
 
 
 
 
Serum chemistries 5, 6 
X 
X16 
X 
X 
X 
X 
X 
X11 
 
 
Urinalysis7 
X 
 
 
 
 
 
 
X11 
 
 
Serum troponin 
X 
X16 
X 
X 
X 
X 
X 
X11 
X 
 
Serum/urine pregnancy test 
X 
 
 
 
 
 
 
 
 
 
Randomization 
 
X15 
 
 
 
 
 
 
 
 
INNO-206 or doxorubicin admin 
administration17 
 
X 
X 
X 
X 
X 
X 
 
 
 
Blood alcohol level18 
 
X 
X 
X 
X 
X 
X 
 
 
 
Concomitant medications 
X9 
X 
X 
X 
X 
X 
X 
X 
 
 
Adverse events 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Telephone call 
 
 
 
 
 
 
 
 
 
X 
NOTE: All assessments must be performed within 72 hr of each specified time parameter, except Cycle 1 (see Section 7 for details).