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NCT01003938 · ClinicalTrials.gov registry record · Phase 2
Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer
A Phase 2 study, sponsored by NYU Langone Health.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01003938: Clinical Trial Phase 2 study, sponsored by NYU Langone Health.
NCT01003938 is a Phase 2 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01003938, a Phase 2 study, was terminated before completion, sponsored by NYU Langone Health.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a single arm phase II study with a combination of Hycamptin® (topotecan) and erlotinib for a minimum of 2 cycles in patients (18 yrs of age and older) with recurrent ovarian cancer previously treated with chemotherapy drug Hycamptin® (topotecan). Up to 30 patients will be enrolled in this study.
Primary Outcome
Response was assessed after every treatment cycle. Response rate is defined as number of the patients who experienced complete or partial CA125 response (CR or PR). CR: normalization of the CA125 value, determined by 2 observations not less than 4 weeks apart; PR: CA125 decreases by \>50% and is confirmed to be 50% or greater on a subsequent determination at least one month later.
Interventions
- DRUG Topotecan
- DRUG Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2009-08 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
Why NCT01003938 stopped before completion
NCT01003938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Topotecan is the first listed.
NCT01003938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01003938 about?
NCT01003938 is a clinical study titled "Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer". This is a single arm phase II study with a combination of Hycamptin® (topotecan) and erlotinib for a minimum of 2 cycles in patients (18 yrs of age and older) with recurrent ovarian cancer previously treated with chemotherapy drug Hycamptin® (topotecan). Up to 30 patients will be enrolled in this st...
What is the current status of trial NCT01003938?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2009-08. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01003938?
The interventions under investigation include: Topotecan (DRUG), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT01003938?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01003938's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 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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