LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients
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.
Timeline
- Start
- 2008-05
- Primary completion
- 2009-01
- Completion
- 2011-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 825 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Subject | Lapatinib | Small molecule | 1000 mg | Oral |
| Subject | Panobinostat | Small molecule | 20 mg | — |
| Subject | Panobinostat | Small molecule | 30 mg | — |
| Subject | Panobinostat | Small molecule | 45 mg | — |
| Subject | Panobinostat | Small molecule | 60 mg | — |