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NCT00657137 · ClinicalTrials.gov registry record · Phase 2
APRiCOT-B: Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer (TP2001-202)
A Phase 2 study, sponsored by Tragara Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT00657137: Clinical Trial Phase 2 study, sponsored by Tragara Pharmaceuticals.
NCT00657137 is a Phase 2 study that was terminated before completion, run by Tragara Pharmaceuticals. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00657137, a Phase 2 study, was terminated before completion, sponsored by Tragara Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study will compare the anti-tumor efficacy of apricoxib and lapatinib/capecitabine with placebo and lapatinib/capecitabine as measured by time to disease progression and evaluate urinary PGE-M measurements or baseline COX-2 expression in tumor tissue by IHC as a surrogate selection criterion for patients who will benefit from future treatment with apricoxib.
Interventions
- DRUG apricoxib + lapatinib + capecitabine
- DRUG placebo + lapatinib + capecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2008-04 |
| Est. Completion | 2009-09 |
| Phase | Phase 2 |
Why NCT00657137 stopped before completion
NCT00657137 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which apricoxib + lapatinib + capecitabine is the first listed.
NCT00657137 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00657137 about?
NCT00657137 is a clinical study titled "APRiCOT-B: Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer (TP2001-202)". This study will compare the anti-tumor efficacy of apricoxib and lapatinib/capecitabine with placebo and lapatinib/capecitabine as measured by time to disease progression and evaluate urinary PGE-M measurements or baseline COX-2 expression in tumor tissue by IHC as a surrogate selection criterion fo...
What is the current status of trial NCT00657137?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2008-04. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00657137?
The interventions under investigation include: apricoxib + lapatinib + capecitabine (DRUG), placebo + lapatinib + capecitabine (DRUG).
Who is sponsoring clinical trial NCT00657137?
This trial is sponsored by Tragara Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00657137's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 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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