Study of Rapamycin Plus Ketoconazole in Advanced Cancers
This study has been completed.
University of Chicago
Information provided by (Responsible Party):
Ezra Cohen, MD, University of Chicago
First received: June 27, 2008
Last updated: October 9, 2012
Last verified: October 2012
To determine the maximum tolerated dose, observed toxicities, and dose limiting toxicities, and antitumor response of rapamycin plus ketoconazole in patients with advanced cancers.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase Ib Study Administering Rapamycin (Sirolimus) With Ketoconazole in Patients With Advanced Malignancies|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by University of Chicago:
Primary Outcome Measures:
- maximum tolerated dose [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- observed toxicities [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- anti-tumor response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2004|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Oral Rapamycin once weekly at assigned dose in 4 week cycles. Dosing can continue until disease progression or severe side effects are seen.
Other Names:Drug: Ketoconazole
Twice daily (200mg each time) at the start of the second week of therapy for 4 consecutive days. Dosing continues every week after the second week of therapy.
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