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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 is a Phase 1 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00632489
The ClinicalTrials.gov registry entry for NCT00632489 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SCRI Development Innovations, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Capecitabine is the first listed.
NCT00632489 reports 0 study locations.
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.
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