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Sponsors and Collaborators: |
Swedish Medical Center Novartis |
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Information provided by: | Swedish Medical Center |
ClinicalTrials.gov Identifier: | NCT00690677 |
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.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: LBH589 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of LBH589 in Refractory Colorectal Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | January 2010 (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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory values as follows:
Exclusion Criteria:
Impaired cardiac function including any one of the following:
Contact: Anna Canoy, RN | (206) 386-6923 | anna.canoy@swedish.org |
Contact: Patra Grevstad, RN, MN | (206) 386-2442 | patra.grevstad@swedish.org |
United States, Washington | |
Swedish Medical Center | Recruiting |
Seattle, Washington, United States, 98104 | |
Principal Investigator: Philip Gold, MD |
Principal Investigator: | Philip Gold, MD | Swedish Medical Center |
Responsible Party: | Swedish Medical Center ( Philip Gold, MD ) |
Study ID Numbers: | CLBH589BUS19T, CRC GOLP CNOV 0823 |
Study First Received: | June 3, 2008 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00690677 |
Health Authority: | United States: Food and Drug Administration |
LBH589 Metastatic Colorectal Cancer Refractory Colorectal Cancer |
Methamphetamine Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms |
Amphetamine Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site |