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Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT02200757•ImmunityBio, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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).
+10 more criteria

Locations (29)

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

Key Dates

Start Date

April 20, 2015

Primary Completion Date

May 15, 2017

Completion Date

May 15, 2017

Last Updated

June 25, 2024

Enrollment

135

ACTUAL participants

Conditions

Metastatic Small Cell Lung Cancer

Interventions

Aldoxorubicin

DRUG

Topotecan

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 25, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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