Clinical trial NCT02200757: Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer
Official title: A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer Who Either Relapsed or Were Refractory to Prior Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Small Cell Lung Cancer
Lead sponsor: ImmunityBio, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-25
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of aldoxorubicin compared to topotecan in subjects with metastatic small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years male or female.
2. Histological confirmation of SCLC.
3. Relapsed or refractory to no more than 1 course of a systemic therapy regimen and is incurable by either surgery or radiation.
4. Capable of providing informed consent and complying with trial procedures.
5. ECOG PS 0-2.
6. Life expectancy \>8 weeks.
7. Measurable tumor lesions according to RECIST 1.1 criteria.\[22\]
8. Women must not be able to become pregnant (e.g. 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. Males and their female partner(s) of child-bearing potential must use 2 forms of effective contraception (see Inclusion 8 plus condom or vasectomy for males) from the last menstrual period of the female partner during the study treatment and for 6 months after the final dose of study treatment.
10. Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
11. Accessibility to the site that ensures the subject will be able to keep all study-related appointments.

Exclusion Criteria:

1. Prior exposure to \>375 mg/m2 of doxorubicin or liposomal doxorubicin.
2. Prior treatment with topotecan.
3. Palliative surgery and/or radiation treatment \< 21 days prior to date of randomization.
4. Exposure to any investigational agent within 30 days of date of randomization.
5. Exposure to any systemic chemotherapy within 21 days of date of randomization.
6. Active (symptomatic) central nervous system (CNS) metastasis.
7. History of other malignancies except cured basal cell carcinoma, cutaneous squamous cell carcinoma, melanoma in situ, superficial bladder cancer or carcinoma in situ of the cervix unless documented free of cancer for ≥3 years.
8. Laboratory values: Screening serum creatinine \>1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) \>3×ULN or \>5×ULN if liver metastases are present, total bilirubin \>2×ULN, absolute neutrophil count (ANC) \<1,500/mm3, platelet concentration \<100,000/mm3, hemoglobin \<9 g/dL, albumin \<2 gm/dL.
9. Anion gap \> 16 meq/L or arterial blood pH \< 7.30.
10. Clinically evident congestive heart failure (CHF) \> class II of the New York Heart Association (NYHA) guidelines (Appendix D).
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 (Appendix F).
12. Baseline QTc \>470 msec measured by Fridericia's formula (QTcF) 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 angina pectoris within the last 6 months.
14. Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) below the institution's lower limit of predicted normal.
15. Known history of HIV infection.
16. Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
17. Treatment with p-glycoprotein inhibitors such as cyclosporine A, elacridar, ketoconazole, ritonavir, saquinavir.
18. Major surgery within 30 days prior to date of randomization.
19. Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
20. Any condition that is unstable and could jeopardize the subject's participation in the study.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 24 months
Secondary outcomes:
measure: Number of Participants With Treatment-related Toxicities (Adverse Events)
timeFrame: Treatment was planned to continue until tumor progression is observed, subject asks to withdraw, or unacceptable toxicity occurs, up to 451 days.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Pasadena
country: United States
facility: City of Hope Medical Group
state: California
city: Fleming Island
country: United States
facility: Cancer Specialists of North Florida-Fleming Island
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, P.C.
state: Georgia
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: Cincinnati
country: United States
facility: Oncology Hermatology Care, Inc.
state: Ohio
city: Portland
country: United States
facility: Northwest CCOP Kaiser Permanente
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Cancer Institute
state: Pennsylvania
city: Chattanooga
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Budapest
country: Hungary
facility: Koranyi National Institute of TBC and Pulmonologyhhy
city: Budapest
country: Hungary
facility: Koranyi National Institute of TBC and Pulmonology
city: Debrecen
country: Hungary
facility: University of Debrecen, Medical and Health Science Center, Department of Pulmonology
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Pulmonology
city: Pecs
country: Hungary
facility: Medical Center of the University of Pecs, 1st Department of Internal Medicine
city: Szolnok
country: Hungary
facility: Hetenyi Geza Hospital
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Quiron-Dexeus (IOR)
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: General University Hospital Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Madrid
country: Spain
facility: University Hospital Foundation Jimenez Diaz
city: Madrid
country: Spain
facility: University Hospital La Paz
city: Malaga
country: Spain
facility: Hospital Regional Universitario
city: Sevilla
country: Spain
facility: University Hospital Virgen de Valme
city: Vigo
country: Spain
facility: CHU Xeral
Study officials:
References: