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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00877773 |
Purpose
The goal of this clinical research study is to learn if temsirolimus can help to control advanced cancer in patients who also have a PI3K mutation and/or PTEN loss. The safety of this drug will also be tested.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancers |
Drug: Temsirolimus |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Histology-Independent Study of the mTOR Inhibitor, Temsirolimus, in Patients With Advanced Cancer |
| Estimated Enrollment: | 65 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Temsirolimus: Experimental |
Drug: Temsirolimus
25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Razelle Kurzrock, MD, BS | 713-794-1226 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Razelle Kurzrock, MD, BS | |
| Principal Investigator: | Razelle Kurzrock, MD, BS | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( Razelle Kurzrock, MD, BS / Professor ) |
| Study ID Numbers: | 2008-0827 |
| Study First Received: | April 7, 2009 |
| Last Updated: | October 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00877773 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Advanced cancer Advanced Cancer with genetic mutation Phosphoinositides 3-kinase PI3K PIK3 mutations |
Temsirolimus CCI-779 Torisel mTOR inhibitor |
|
Neoplasms |