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NCT00281632 · ClinicalTrials.gov registry record · Phase 2
A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT00281632: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00281632 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00281632, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
This study was designed to find out how effective and safe GW786034, is in the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to standard treatment.
Primary Outcome
Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: 50% response=≥50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments) then confirmed after 21 days. 50% CA-125 response was normalized (CA-125 \>21U/mL) or non-normalized (CA-125≤1U/mL). Progressive disease (PD) =CA-125 increase ≥100% from nadir (nadir \>21U/mL) or ≥42U/mL (nadir ≤21U/mL); nadir was lowest CA-125. PD was confirmed after 21 days; otherwise=unconfirmed PD. Stable disease=scenarios that do
Interventions
- DRUG GW786034
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2006-03 |
| Est. Completion | 2010-10 |
| Phase | Phase 2 |
What the finished NCT00281632 record still lists
NCT00281632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which GW786034 is the first listed.
NCT00281632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00281632 about?
NCT00281632 is a clinical study titled "A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer". This study was designed to find out how effective and safe GW786034, is in the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to standard treatment.
What is the current status of trial NCT00281632?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2006-03. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00281632?
The interventions under investigation include: GW786034 (DRUG).
Who is sponsoring clinical trial NCT00281632?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00281632's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 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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