Source: https://www.mycancergenome.org/content/clinical_trials/NCT01204164/
Timestamp: 2020-01-18 18:03:27
Document Index: 297025990

Matched Legal Cases: ['arts 1', 'art 4', 'art 1', 'art 2', 'art 3', 'art 4']

Clinical Trial: NCT01204164 - My Cancer Genome
https://clinicaltrials.gov/show/NCT01204164
Brief Title: Phase 1 Study of TG02 Citrate in Patients With Advanced Hematological Malignancies
ORG STUDY ID: TG02-101
NCT ID: NCT01204164
TG02 citrate No other names. TG02 in AL
Carfilzomib Kyprolis TG02 + CFZ in MM
Dexamethasone Ozurdex, Maxidex, Decadron, Baycadron TG02 + CFZ + DEX in CFZ refractory MM
For Parts 1, 2, and 3 of the study, the primary objective is to determine the highest dose of
TG02 citrate that can safely be given to patients with different types of hematological
For Part 4, the primary objective is to evaluate the safety and tolerability of once-weekly
dosing at the maximum-tolerated dose/ Recommended Phase 2 Dose of TG02 in combination with
-  Part 1: single agent TG02 in acute leukemia patients
-  Part 2: single agent TG02 in multiple myeloma patients
-  Part 3: TG02 in combination with carfilzomib in multiple myeloma patients
-  Part 4: TG02 in combination with carfilzomib in carfilzomib refractory multiple myeloma
TG02 in AL Experimental Single agent TG02 citrate in acute leukemia patients
TG02 citrate
TG02 in MM Experimental Single Agent TG02 citrate in multiple myeloma patients
TG02 + CFZ in MM Experimental TG02 in combination with carfilzomib and dexamethasone in multiple myeloma patients
TG02 + CFZ + DEX in CFZ refractory MM Experimental TG02 in combination with carfilzomib and dexamethasone in carfilzomib refractory multiple myeloma patients
-  Relapsed AML, ALL, CML in blast crisis, or MDS
-  65+ yrs with AML not eligible for standard frontline chemo
-  Interval from prior treatment to time of study drug at least 5 half-lives for
cytotoxic/ noncytotoxic agents.
-  Persistent clinically significant toxicities from prior chemo ≤ Grd 1
-  ECOG PS 0-2
-  Lab values:
-  Cr ≤ 2X ULN
-  ALT and/or AST ≤2.5 X ULN
-  Total bilirubin ≤1.5 X ULN unless considered due to Gilbert's syndrome
-  Can take oral med
-  Relapsed multiple myeloma. At least ≥1 line of therapy and progressed after ≥1 prior
-  Measurable disease defined as at least one of the following:
-  Serum M ≥500 mg/dL
-  Urine M ≥200 mg per 24hr
-  Involved FLC ≥10 mg/dL and abnormal FLC ratio in serum (<0.26 or >1.65)
-  Measurable soft tissue plasmacytoma
-  ANC of >1000/mm3
-  Platelets ≥50,000/mm3
-  Cr ≤2X the ULN
-  ALT and/or AST ≤2.5X ULN
-  Total bilirubin ≤1.5X ULN, unless considered due to Gilbert's syndrome
-  Urine M protein ≥200 mg per 24hr
-  Involved FLC level ≥10 mg/dL and abnormal FLC ratio in serum (<0.26 or >1.65)
-  Meet at least one of the criteria below:
-  a. ≥2 prior therapies including proteasome inhibitor and immunomodulatory agent
-  b. ≥1 prior therapy and one of the following abnormalities: 17p del, p53, 1q amp,
1p del, t(4;14)
-  Interval from prior treatment to time of study drug at least 5 half-lives or 3 wks,
which ever is shorter, for noncytotoxic agents
-  Persistent clinically significant toxicities from prior chemo ≤ Grd 1 or Grd 2
-  ANC of >1000/mm3 independent of G-CSF
-  Platelets ≥50,000/mm3 independent of transfusion
-  MDRD calculated or measured CrCl of ≥30 mL/min
-  ALT and/or AST ≤3X ULN
-  Total bilirubin ≤2X ULN, unless considered due to Gilbert's syndrome
-  Involved FLC level ≥10 mg/dL and an abnormal FLC ratio in serum (<0.26 or >1.65)
-  Received prior therapies including:
-  a. bortezomib
-  b. an IMiD
-  c. carfilzomib. Demonstrated disease progression on or within 60d of completion
of carfilzomib therapy
which ever is shorter, for noncytotoxic agents.
-  Persistent clinically significant toxicities from prior chemo ≤ Grd 1, or Grd 2
neuropathy without pain.
-  Previous allogenic hematopoietic transplant within 90 d
-  Concurrent severe or uncontrolled medical disease that would compromise the safety or
compromise the ability of the patient to complete the study
-  Prolonged QTC interval >450ms
-  Symptomatic CNS metastases
-  Known HIV or AIDS
-  Actively treated for a second malignancy
-  Multiple myeloma of IgM subtype, POEMS, plasma cell leukemia
-  Corticosteroids discontinued ≥7 days of initiating therapy
-  Previous chemo within 2 wks
-  Hx of ventricular arrhythmia or symptomatic conduction abnormality within 12m
-  CHF, symptomatic ischemia, conduction abnormalities uncontrolled by conventional
intervention, myocardial infarction within 6m
-  Prolonged QTc interval (males >450ms, females >470ms)
-  Previous allogeneic hematopoietic transplant within 90 days of study enrollment,
Active GVHD requiring treatment.
-  Prior or 2nd malignancy, except non-melanoma skin cancer, completely resected cervical
or prostate cancer (with PSA of less than or equal to 0.1 ng/ml), or other cancer for
which the subject has received curative therapy at least 3 yrs prior to study entry
-  Significant neuropathy (Grd 3-4 or Grd 2 with pain) at the time of 1st dose
-  Primary AL amyloidosis
-  Pleural effusions requiring thoracentesis or ascites requiring paracentesis
-  Hx ventricular arrhythmia or symptomatic conduction abnormality within 12m
intervention, and myocardial infarction within 6m
-  Previous allogeneic hematopoietic transplant within 90 days. Active GVHD requiring
compromise the ability of the patient to complete study
Description: Maximum Tolerated Dose refers to the highest dose of TG02 administered that will produce the desired effect without unacceptable toxicity.
Description: Safety data will include vital signs, ECGs, PE findings, clinical laboratory parameters, ECOG PS, AEs/SAEs and concomitant medications.
Measure: Pharmacokinetics of TG02
Description: Plasma will be analyzed to determine TG02 concentration.
Measure: Clinical Benefit Response
Description: Clinical Benefit Response is defined as the sum of all response categories for Overall Response Rate (ORR is defined as the sum of patients with sCR, CR, VGPR and PR) plus minimal response (MR).
Description: Overall Response Rate is defined as the sum of patients with sCR, CR, VGPR and PR.
Description: Progression-Free Survival is the time to disease progression or death, which is measured from the date of first study drug administration until the first date that recurrent or progressive disease is objectively documented or the date of death.
Description: Overall Survival is time to death, which is measured from the date of first study drug administration until the date of death.
Description: Duration of Response is the duration from first observation of response to the first documentation of disease progression, with deaths from causes other than disease progression censored. For the purposes of the calculation of the DOR, the date at which the response status was first observed rather than the date of confirmation is used as the start date.
Measure: Pharmacodynamics
Description: Pharmacodynamic sampling may include whole blood and bone marrow at baseline and post-treatment for pathway determination if available.
Lead Sponsor: Tragara Pharmaceuticals, Inc.