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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00877773 |
Objectives:
To correlate, in a descriptive fashion:
Condition | Intervention | Phase |
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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 |
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Temsirolimus: Experimental |
Drug: Temsirolimus
25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must be off other anti-tumor agents for at least 5 half lives of the agent or 4 wks from the last day of treatment, whichever is shorter.
For cytotoxic therapies, patients should be off treatment for 3 or more weeks.
Exclusion Criteria:
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 |
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: | April 7, 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 |
Sirolimus |
Neoplasms |