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| Sponsor: | University of Chicago |
|---|---|
| Information provided by: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00708591 |
Purpose
To determine the maximum tolerated dose, observed toxicities, and dose limiting toxicities, and antitumor response of rapamycin plus ketoconazole in patients with advanced cancers.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancer |
Drug: Rapamycin Drug: Ketoconazole |
Phase I |
| Study Type: | Interventional |
| 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 |
| Enrollment: | 57 |
| Study Start Date: | October 2004 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Rapamycin
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Normal organ and marrow function as defined below:
Leukocytes ≥ 3,000/µL
o WBC ≥ 1,500/µL for patients with hematologic malignancies
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Ezra Cohen, MD, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00708591 History of Changes |
| Other Study ID Numbers: | UCIRB 13274B |
| Study First Received: | June 27, 2008 |
| Last Updated: | February 12, 2009 |
| Health Authority: | United States: Institutional Review Board |
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Neoplasms Ketoconazole Sirolimus Everolimus 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antifungal Agents |
Anti-Infective Agents Therapeutic Uses Antibiotics, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |