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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 |
| 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 2009 |
| Estimated Primary Completion Date: | November 2009 (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
Absolute neutrophil count (ANC) greater or equal to 1,500/μL
Platelets (PLT) greater or equal to 100,000/μL
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| University of Chicago Hospitals | |
| Chicago, Illinois, United States, 60637 | |
| Principal Investigator: | Ezra W Cohen, MD | University of Chicago |
More Information
| Responsible Party: | University of Chicago ( Ezra Cohen, MD ) |
| Study ID Numbers: | 14435B |
| Study First Received: | September 11, 2006 |
| Last Updated: | February 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00375245 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
phase I metastatic advanced cancer lung cancer renal cancer kidney cancer head and neck cancer bladder cancer breast cancer colorectal cancer esophagus GIST |
liver cancer melanoma mesothelioma lymphoma ovary cancer ovarian cancer pancreas cancer pancreatic cancer prostate cancer stomach cancer thyroid cancer Metastatic solid tumor |
|
Sirolimus Immunologic Factors Pancreatic Neoplasms Pancrelipase Melanoma Liver Neoplasms Anti-Bacterial Agents Renal Cancer Lung Neoplasms Kidney Neoplasms Antifungal Agents Stomach Neoplasms Neoplasm Metastasis Ovarian Cancer Bladder Neoplasm |
Lymphoma Grapefruit Seed Extract Kidney Cancer Ovarian Neoplasms Thyroid Neoplasms Urinary Bladder Neoplasms Breast Neoplasms Immunosuppressive Agents Head and Neck Neoplasms Carcinoma, Renal Cell Mesothelioma Stomach Cancer Prostatic Neoplasms Colorectal Neoplasms |
|
Sirolimus Anti-Infective Agents Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |
Anti-Bacterial Agents Neoplastic Processes Neoplasms Pathologic Processes Therapeutic Uses Antifungal Agents Neoplasm Metastasis |