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Sponsors and Collaborators: |
University of Chicago Pfizer |
Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00583063 |
Determine the pharmacokinetic interactions between rapamycin and sunitinib in patients with advanced solid tumors.
Condition | Intervention | Phase |
Solid Tumors |
Drug: sunitinib Drug: rapamycin |
Phase 0 |
MedlinePlus related topics: | Cancer |
Drug Information available for: | Sunitinib Sunitinib malate Sirolimus |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study |
Official Title: | A Pharmacokinetic Interaction Study of Rapamycin (Sirolimus) and SU11248 (Sunitinib) in Patients With Advanced Solid Tumors |
Enrollment: | 23 |
Study Start Date: | October 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
Sunitinib taken by mouth every day. Rapamycin (taken by mouth) will be started on Day 15 and then taken every day. Drugs can be taken until disease progression.
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Drug: sunitinib
25 mg daily (oral dosing)
Drug: rapamycin
4 mg daily (oral dosing)
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B: Experimental
Rapamycin taken by mouth every day. Sunitinib (taken by mouth) will be started on Day 15 and then taken every day. Drugs can be taken until disease progression.
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Drug: sunitinib
25 mg daily (oral dosing)
Drug: rapamycin
4 mg daily (oral dosing)
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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:
Exclusion Criteria:
Patients with any of the following conditions are excluded:
United States, Illinois | |||||
University of Chicago | |||||
Chicago, Illinois, United States, 60637 |
University of Chicago |
Pfizer |
Principal Investigator: | Ezra Cohen, MD | University of Chicago |
Responsible Party: | University of Chicago ( Ezra Cohen, MD ) |
Study ID Numbers: | 15328B |
First Received: | December 20, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00583063 |
Health Authority: | United States: Institutional Review Board |
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