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Sponsored by: |
University of Chicago |
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Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00708591 |
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: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase Ib Study Administering Rapamycin (Sirolimus) With Ketoconazole in Patients With Advanced Malignancies |
Estimated Enrollment: | 60 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
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.
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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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:
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Kammi Fox-Kay, RN 773-702-0891 kfox-kay@medicine.bsd.uchicago.edu | |
Contact: Pam Vogel, RN 773-702-0891 pvogel@bsd.uchicago.edu | |
Principal Investigator: Ezra Cohen, MD |
Principal Investigator: | Ezra Cohen, MD | University of Chicago |
Responsible Party: | University of Chicago ( Ezra Cohen, MD ) |
Study ID Numbers: | UCIRB 13274B |
Study First Received: | June 27, 2008 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00708591 |
Health Authority: | United States: Institutional Review Board |
Sirolimus Clotrimazole Miconazole Tioconazole Ketoconazole |
Anti-Bacterial Agents Anti-Infective Agents Neoplasms Immunologic Factors Antineoplastic Agents Therapeutic Uses |
Antifungal Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |