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NCT00632489 · ClinicalTrials.gov registry record · Phase 1
LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients
A Phase 1 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00632489: Completed Phase 1 study, sponsored by SCRI Development Innovations.
NCT00632489 is a Phase 1 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00632489, a Phase 1 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This single center Phase I dose escalation trial will evaluate the safety, tolerability and efficacy of LBH589 when combined with capecitabine and lapatinib in three parts. Part 1 will determine the maximum tolerated doses (MTD) of LBH589 when combined with capecitabine. Parts 2 and 3 will be limited to locally recurrent or metastatic breast cancer patients, ICH 3+ overexpression or FISH amplification documented locally. Part 2 will evaluate the safety of the MTD of LBH589 determined in Part 1 when paired with lapatinib 1000 mg by mouth (PO) daily. Parts 2 and 3 will be limited to locally recurrent or metastatic breast cancer patients, ICH 3+ overexpression or FISH amplification documented locally. Part 3 will evaluate the tolerability and effectiveness of the triplet combination, LBH589, capecitabine and lapatinib in breast cancer patients.
Primary Outcome
MTD for Capecitabine, BID
Interventions
- DRUG Capecitabine
- DRUG Lapatinib
- DRUG LBH589
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2008-05 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
What the finished NCT00632489 record still lists
NCT00632489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 3 interventions - of which Capecitabine is the first listed.
NCT00632489 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00632489 about?
NCT00632489 is a clinical study titled "LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients". This single center Phase I dose escalation trial will evaluate the safety, tolerability and efficacy of LBH589 when combined with capecitabine and lapatinib in three parts. Part 1 will determine the maximum tolerated doses (MTD) of LBH589 when combined with capecitabine. Parts 2 and 3 will be limite...
What is the current status of trial NCT00632489?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2008-05. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00632489?
The interventions under investigation include: Capecitabine (DRUG), Lapatinib (DRUG), LBH589 (DRUG).
Who is sponsoring clinical trial NCT00632489?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00632489's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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