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NCT00634088 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Ixabepilone Plus Lapatinib With or Without Capecitabine in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
A Phase 1 study, sponsored by R-Pharm.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT00634088: Clinical Trial Phase 1 study, sponsored by R-Pharm.
NCT00634088 is a Phase 1 study that was terminated before completion, run by R-Pharm. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00634088, a Phase 1 study, was terminated before completion, sponsored by R-Pharm.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and preliminary effectiveness of ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal growth factor receptor 2 (HER2)-positive or metastatic breast cancer.
Primary Outcome
The MTD is defined as the maximum dose that can be administered to 6 participants such that no more than 1 (or fewer than one third if more than 6 participants receive treatment) experiences a dose-limiting toxicity (DLT), with at least 2 experiencing a DLT at the next higher dose level. The RP2D is based on the MTD and the assessment of any relevant chronic toxicities.
Interventions
- DRUG Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg
- DRUG Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg
- DRUG Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg
- DRUG Ixabepilone + Lapatinib + Capecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2008-06 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
Why NCT00634088 stopped before completion
NCT00634088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 4 interventions - of which Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg is the first listed.
NCT00634088 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00634088 about?
NCT00634088 is a clinical study titled "Phase I Study of Ixabepilone Plus Lapatinib With or Without Capecitabine in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer". The purpose of this study is to determine the safety and preliminary effectiveness of ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal growth factor receptor 2 (HER2)-positive or metastatic breast cancer.
What is the current status of trial NCT00634088?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2008-06. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00634088?
The interventions under investigation include: Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg (DRUG), Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg (DRUG), Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg (DRUG), Ixabepilone + Lapatinib + Capecitabine (DRUG).
Who is sponsoring clinical trial NCT00634088?
This trial is sponsored by R-Pharm, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00634088's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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