|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | 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: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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
** 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 | |
| Chicago, Illinois, United States, 60637 | |
| Principal Investigator: | Ezra W Cohen, MD | University of Chicago |
More Information
| Responsible Party: | Ezra Cohen, MD, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00375245 History of Changes |
| Other Study ID Numbers: | 14435B |
| Study First Received: | September 11, 2006 |
| Last Updated: | February 12, 2009 |
| 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 |
|
Neoplasms Neoplasm Metastasis Neoplastic Processes Pathologic Processes Sirolimus Everolimus Antibiotics, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |