Phase II Trial of LBH589 in Refractory Colorectal Cancer
The purpose of this study is to determine the effects of the study drug, LBH589, on patients with metastatic colorectal cancer that has continued to grow despite previous treatment.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of LBH589 in Refractory Colorectal Cancer|
- To evaluate the effect of LBH589 on overall survival (OS) in patients with colorectal cancer [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Time to tumor progression and response rates [ Time Frame: 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
LBH589 will be administered orally at a dose of 30mg (1 - 20mg capsule and 2 - 5g capsules) on Monday, Wednesday and Friday of each week (three times a week). Patients may continue treatment with oral LBH589 until they experience unacceptable toxicity that precludes further treatment, disease progression, and/or at the discretion of the investigator.
The LBH589 capsules should be swallowed by mouth with a glass of water in the morning. The recommended way to take LBH589 is after not eating for at least 2 hours. You should also not eat for another 2 hours after taking your LBH589 capsules. The daily dose of LBH589 should be taken at approximately the same time each day. You should avoid eating grapefruit, seville oranges, or drinking grapefruit or seville orange juice during the study.
|United States, Washington|
|Swedish Medical Center|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Philip Gold, MD||Swedish Medical Center|