Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer
NCT ID: NCT02200757
Last Updated: 2024-06-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
135 participants
INTERVENTIONAL
2015-04-20
2017-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Aldoxorubicin
Aldoxorubicin
230 mg/m2 (170 mg/m2 doxorubicin equivalent) intravenously on Day 1 of each 21-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs.
Topotecan
Topotecan
1.5 mg/m2/day intravenously for 5 consecutive days on Day 1 of each 21-day cycle OR 4 mg/m2 intravenously on Days 1, 8 and 15 of each 28-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs
Interventions
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Aldoxorubicin
230 mg/m2 (170 mg/m2 doxorubicin equivalent) intravenously on Day 1 of each 21-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs.
Topotecan
1.5 mg/m2/day intravenously for 5 consecutive days on Day 1 of each 21-day cycle OR 4 mg/m2 intravenously on Days 1, 8 and 15 of each 28-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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ImmunityBio, Inc.
INDUSTRY
Responsible Party
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Locations
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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
University Hospital La Paz
Madrid, , Spain
Hospital Regional Universitario
Málaga, , Spain
University Hospital Virgen de Valme
Seville, , Spain
CHU Xeral
Vigo, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ALDOXORUBICIN-P2-SCLC-01
Identifier Type: -
Identifier Source: org_study_id
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