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NCT01500720 · ClinicalTrials.gov registry record · Phase 2
Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 179
- Enrollment target
NCT01500720: Completed Phase 2 study, sponsored by Sanofi.
NCT01500720 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 179 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01500720, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 179 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy. Secondary Objectives: * To assess disease progression free rate at 12 weeks * To assess Response Rate (Response Evaluation Criteria in Solid Tumor \[RECIST\] 1.1) and duration of response * To assess Overall Survival (OS) * To assess the Safety (National Cancer Institute - Common Toxicity Criteria \[NCI-CTC\] version 4.03) * To assess the Health-Related Quality of Life (HRQoL)
Primary Outcome
PFS was defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever came first. Median PFS was estimated using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-t
Interventions
- DRUG Topotecan
- DRUG Cabazitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2012-03 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
What the finished NCT01500720 record still lists
NCT01500720 is an interventional study that assigns participants to a tested intervention. The registered 179 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 2 interventions - of which Topotecan is the first listed.
NCT01500720 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01500720 about?
NCT01500720 is a clinical study titled "Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer". Primary Objective: To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy. Secondary Objectives: * To assess disease progressi...
What is the current status of trial NCT01500720?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 179 participants. The study started on 2012-03. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01500720?
The interventions under investigation include: Topotecan (DRUG), Cabazitaxel (DRUG).
Who is sponsoring clinical trial NCT01500720?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01500720's enrollment target sits among peer trials
179 391st of 2000 higher than 1,610 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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