Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Metastatic Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02200757

Run by

ImmunityBio, Inc.

People needed

135

Starts

2015-04-20

Expected to finish

2017-05-15

Last updated by the study team

2024-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years male or female.
• Histological confirmation of SCLC.
• Relapsed or refractory to no more than 1 course of a systemic therapy regimen and is incurable by either surgery or radiation.
• Capable of providing informed consent and complying with trial procedures.
• ECOG PS 0-2.
• Life expectancy >8 weeks.
• Measurable tumor lesions according to RECIST 1.1 criteria.[22]
• 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.)
• 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.
• Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
• Accessibility to the site that ensures the subject will be able to keep all study-related appointments.

You may not qualify if…

• Prior exposure to >375 mg/m2 of doxorubicin or liposomal doxorubicin.
• Prior treatment with topotecan.
• Palliative surgery and/or radiation treatment < 21 days prior to date of randomization.
• Exposure to any investigational agent within 30 days of date of randomization.
• Exposure to any systemic chemotherapy within 21 days of date of randomization.
• Active (symptomatic) central nervous system (CNS) metastasis.
• 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.
• 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.
• Anion gap > 16 meq/L or arterial blood pH < 7.30.
• Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines (Appendix D).
• 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).
• 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.
• History or signs of active coronary artery disease with angina pectoris within the last 6 months.
• Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) below the institution's lower limit of predicted normal.
• Known history of HIV infection.
• Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
• Treatment with p-glycoprotein inhibitors such as cyclosporine A, elacridar, ketoconazole, ritonavir, saquinavir.
• Major surgery within 30 days prior to date of randomization.
• Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
• Any condition that is unstable and could jeopardize the subject's participation in the study.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• City of Hope Medical Group — Pasadena, California, United States
• Cancer Specialists of North Florida-Fleming Island — Fleming Island, Florida, United States
• Northwest Georgia Oncology Centers, P.C. — Marietta, Georgia, United States
• James Graham Brown Cancer Center — Louisville, Kentucky, United States
• Oncology Hermatology Care, Inc. — Cincinnati, Ohio, United States
• Northwest CCOP Kaiser Permanente — Portland, Oregon, United States
• Penn State Hershey Cancer Institute — Hershey, Pennsylvania, United States
• Tennessee Oncology — Chattanooga, Tennessee, United States
• Tennessee Cancer Specialists — Knoxville, Tennessee, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Koranyi National Institute of TBC and Pulmonologyhhy — Budapest, Hungary
• Koranyi National Institute of TBC and Pulmonology — Budapest, Hungary
• University of Debrecen, Medical and Health Science Center, Department of Pulmonology — Debrecen, Hungary
• Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Pulmonology — Nyíregyháza, Hungary
• Medical Center of the University of Pecs, 1st Department of Internal Medicine — Pécs, Hungary
• Hetenyi Geza Hospital — Szolnok, Hungary
• Hospital General Universitario de Alicante — Alicante, Spain
• Hospital Clinic i Provincial de Barcelona — Barcelona, Spain
• Hospital Universitario Quiron-Dexeus (IOR) — Barcelona, Spain
• University Hospital Vall d'Hebron — Barcelona, Spain
• Hospital Universitario Lucus Augusti — Lugo, Spain
• General University Hospital Gregorio Maranon — Madrid, Spain
• Hospital Puerta de Hierro — Madrid, Spain
• University Hospital Foundation Jimenez Diaz — Madrid, Spain

Full record on ClinicalTrials.gov

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