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

Phase 2

Completed

• Conditions: Metastatic Small Cell Lung Cancer
• Interventions: Drug: Aldoxorubicin; Drug: Topotecan

• Registration Number: NCT02200757
• Lead Sponsor: ImmunityBio, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Study Start: 2015-04-20
• Status Verified: 2016-01
• Primary Completion: 2017-05-15
• Study Completion: 2017-05-15
• Results First Submitted: 2024-04-05
• Results First Submitted QC: 2024-06-03
• Last Update Submitted: 2024-06-03
• Results First Posted: 2024-06-25
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aldoxorubicin	Aldoxorubicin	-
Topotecan	Topotecan	-

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	24 months	PFS is defined as the time from the date of randomization to first documentation of objective tumor progression or to death due to any cause in the absence of previous documentation of objective tumor progression.; Progressive Disease is defined as: ≥20% increase in the sum of the longest diameter of target lesions from the smallest sum of the longest diameter recorded since the treatment started; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of ≥1 new lesion is also considered progression.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-related Toxicities (Adverse Events)	Treatment was planned to continue until tumor progression is observed, subject asks to withdraw, or unacceptable toxicity occurs, up to 451 days.

Trial Locations

Locations (29)

Northwest Georgia Oncology Centers, P.C.; 🇺🇸 Marietta, Georgia, United States

Tennessee Oncology; 🇺🇸 Chattanooga, Tennessee, United States

Oncology Hermatology Care, Inc.; 🇺🇸 Cincinnati, Ohio, United States

Medical Center of the University of Pecs, 1st Department of Internal Medicine; 🇭🇺 Pecs, Hungary

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

Northwest CCOP Kaiser Permanente; 🇺🇸 Portland, Oregon, United States

James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States

Tennessee Cancer Specialists; 🇺🇸 Knoxville, Tennessee, United States

Hospital Universitario Quiron-Dexeus (IOR); 🇪🇸 Barcelona, Spain

CHU Xeral; 🇪🇸 Vigo, Spain

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; 🇭🇺 Nyiregyhaza, Hungary

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

University Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

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

Penn State Hershey Cancer Institute; 🇺🇸 Hershey, Pennsylvania, United States

Hetenyi Geza Hospital; 🇭🇺 Szolnok, Hungary

Hospital Clinic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

General University Hospital Gregorio Maranon; 🇪🇸 Madrid, Spain

Hospital Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital Universitario Lucus Augusti; 🇪🇸 Lugo, Spain

University Hospital Foundation Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Regional Universitario; 🇪🇸 Malaga, Spain

University Hospital La Paz; 🇪🇸 Madrid, Spain

University Hospital Virgen de Valme; 🇪🇸 Sevilla, Spain

Koranyi National Institute of TBC and Pulmonology; 🇭🇺 Budapest, Hungary

Koranyi National Institute of TBC and Pulmonologyhhy; 🇭🇺 Budapest, Hungary