Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02200757|
Recruitment Status : Unknown
Verified January 2016 by CytRx.
Recruitment status was: Recruiting
First Posted : July 25, 2014
Last Update Posted : August 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Small Cell Lung Cancer||Drug: Aldoxorubicin Drug: Topotecan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2014|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||July 2017|
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.
Other Name: INNO-206
|Active Comparator: 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 Name: Hycamtin
- Progression-Free Survival (PFS) [ Time Frame: 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.
- Overall Survival (OS) [ Time Frame: 36 months ]Overall survival is defined as the time from randomization to date of death. In the absence of confirmation of death, survival time will be censored at the last date the subject is known to be alive.
- Safety Measures [ Time Frame: 24 months ]The safety of aldoxorubicin compared to topotecan in this population assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiogram (ECHO) evaluations, electrocardiogram (ECG) results, and weight, as well as disease control rate and tumor response.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200757