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| Sponsored by: |
University of Chicago |
| Information provided by: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00375245 |
Purpose
The purpose of this study is to determine the highest safe dose of rapamycin when given with a fixed amount of grapefruit juice.
| Condition | Intervention | Phase |
|
Tumors Neoplasm Metastasis |
Drug: Rapamycin (sirolimus) Other: Grapefruit Juice |
Phase I |
| Genetics Home Reference related topics: | bladder cancer breast cancer |
| MedlinePlus related topics: | Cancer |
| Drug Information available for: | Sirolimus Thyroid Pancrelipase Ultrase |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | A Phase Ib Study Administering Rapamycin (Sirolimus) With Grapefruit Juice in Patients With Advanced Malignancies |
| Estimated Enrollment: | 64 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | November 2008 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
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:
Leukocytes greater or equal to 3,000/μL
** White blood cell (WBC) greater or equal to 1,500/μL for patients with hematologic malignancies
Absolute neutrophil count (ANC) greater or equal to 1,500/μL
** ANC greater or equal to 1,000/μL for patients with hematologic malignancies
Platelets (PLT) greater or equal to 100,000/μL
** PLT greater or equal to 50,000/μL for patients with hematologic malignancies
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |||||
| University of Chicago Hospitals | Recruiting | ||||
| Chicago, Illinois, United States, 60637 | |||||
| Contact: Kammi Fox-Kay, RN 773-702-0891 kfox-kay@medicine.bsd.uchicago.edu | |||||
| University of Chicago |
| Principal Investigator: | Ezra W Cohen, MD | University of Chicago |
More Information
| Responsible Party: | University of Chicago ( Ezra Cohen, MD ) |
| Study ID Numbers: | 14435B |
| First Received: | September 11, 2006 |
| Last Updated: | April 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00375245 |
| Health Authority: | United States: Institutional Review Board |
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