|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Sarah Cannon Research Institute |
|---|---|
| Collaborators: |
SCRI Oncology Research Consortium Novartis |
| Information provided by: | Sarah Cannon Research Institute |
| ClinicalTrials.gov Identifier: | NCT00550199 |
Purpose
This will be a single center phase I dose escalation trial. LBH589 will be administered orally twice weekly. Gemcitabine will be administered intravenously over 30 minutes on days 1, 8, and 15 every 28 days. Dose escalation will begin at Dose Level 1. Three patients will be enrolled at each dose level. If 1/3 patients experiences dose-limiting toxicity, the dose level will be expanded to 6 patients. If 2/6 patients experience dose-limiting toxicity at a specific dose level, then the previous dose level will be considered the recommended phase II dose. Dose escalation will continue until the maximum tolerated dose is determined or until all dose levels outlined in the protocol have been completed. A total of 10 patients will be treated at the dose that is recommended for further phase II evaluation to further assess the safety of the combination regimen. Toxicity assessments will be ongoing and disease assessments will be repeated every 2 treatment cycles. Patients will be allowed to continue on study until disease progression unless toxicity warrants drug discontinuation.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: LBH589, Gemcitabine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
| Official Title: | A Phase I Study of LBH589 in Combination With Gemcitabine in the Treatment of Solid Tumors |
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Treatment
Phase I dose escalation study
|
Drug: LBH589, Gemcitabine
Phase I dose escalation: LBH589 will be administered orally twice weekly. Gemcitabine will be administered intravenously over 30 minutes on days 1, 8, and 15 every 28 days.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory values as follows:
8. Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. 9. Life expectancy > 12 weeks. 10. Accessible for treatment and follow-up. 11. All patients must be able to understand the nature of the study and be given written informed consent prior to study entry.
Exclusion Criteria:
Impaired cardiac function including any of the following:
Contacts and Locations| United States, Tennessee | |
| Tennessee Oncology, PLLC | |
| Nashville, Tennessee, United States, 37023 | |
| Study Chair: | Howard Burris, M.D. | SCRI Oncology Research Consortium |
More Information
| Responsible Party: | Sarah Cannon Research Institute ( Howard A. Burris, III, M.D. ) |
| Study ID Numbers: | SCRI REFMAL 120, IND 79,355 |
| Study First Received: | October 26, 2007 |
| Last Updated: | July 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00550199 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Solid Tumors Phase I LBH589 Gemcitabine |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Therapeutic Uses Gemcitabine |