Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin (PI3K-mTOR) in Advanced Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00877773|
Recruitment Status : Terminated (Slow Accrual)
First Posted : April 8, 2009
Results First Posted : August 25, 2016
Last Update Posted : August 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancers||Drug: Temsirolimus||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Histology-Independent Study of the mTOR Inhibitor, Temsirolimus, in Patients With Advanced Cancer|
|Study Start Date :||April 2009|
|Primary Completion Date :||June 2014|
|Study Completion Date :||June 2014|
Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
- Tumor Response [ Time Frame: Baseline to Disease Progression (restaged at 8 weeks and at 4 months) ]For solid tumors, initial responses defined by Response Evaluation Criteria in Solid (RECIST) criteria in the evaluable lesion(s) per Complete Response (CR): Disappearance of all target lesions; confirmed at 4 weeks; Partial Response (PR): At least 30% decrease; confirmed at 4 weeks; Stable Disease (SD): Neither PR nor PD criteria met; Progressive Disease (PD): 20% increase; no CR, PR or SD documented before increased disease, or new lesion(s).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877773
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Daniel Karp, MD||UT MD Anderson Cancer Center|