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NCT00887159 · ClinicalTrials.gov registry record · Phase 2
A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
NCT00887159: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00887159 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 168 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00887159, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
Study Summary
This randomized phase II trial studies cisplatin and etoposide to see how well they work when given with or without Hedgehog inhibitor GDC-0449 (vismodegib) or IGF-1R MOAB IMC-A12 (cixutumumab) in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Etoposide may slow the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vismodegib may slow the growth of tumor cells. Monoclonal antibodies, such as cixutumumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving cisplatin and etoposide are more effective when given together with vismodegib or cixutumumab in treating small cell lung cancer.
Primary Outcome
Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free.
Interventions
- DRUG Cisplatin
- OTHER Laboratory Biomarker Analysis
- DRUG Etoposide
- DRUG Vismodegib
- BIOLOGICAL Cixutumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2009-07-16 |
| Est. Completion | 2016-11-15 |
| Phase | Phase 2 |
What the finished NCT00887159 record still lists
NCT00887159 is an interventional study that assigns participants to a tested intervention. The registered 168 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 (26% higher).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT00887159 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00887159 about?
NCT00887159 is a clinical study titled "A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage". This randomized phase II trial studies cisplatin and etoposide to see how well they work when given with or without Hedgehog inhibitor GDC-0449 (vismodegib) or IGF-1R MOAB IMC-A12 (cixutumumab) in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as cisp...
What is the current status of trial NCT00887159?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2009-07-16. Estimated completion is 2016-11-15.
What interventions are being tested in trial NCT00887159?
The interventions under investigation include: Cisplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Etoposide (DRUG), Vismodegib (DRUG), Cixutumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00887159?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00887159's enrollment target sits among peer trials
168 403rd of 2000 higher than 1,595 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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