Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin (PI3K-mTOR) in Advanced Cancer Patients
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: April 7, 2009
Last updated: March 29, 2013
Last verified: March 2013
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Histology-Independent Study of the mTOR Inhibitor, Temsirolimus, in Patients With Advanced Cancer
Primary Outcome Measures:
- Tumor Response [ Time Frame: Baseline to Disease Progression (restaged at 8 weeks and at 4 months) ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2016 (Final data collection date for primary outcome measure)
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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients with pathologically confirmed advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or has no standard therapy that improves survival by at least 3 months (unless temsirolimus is indicated as standard treatment for that disease).
- Patients must have evaluable tumor(s) with documented PIK3 mutation and/or PTEN loss.
- Patients must have creatinine </= 3 X ULN; absolute neutrophil count >/= 1,000/mL; platelets >/= 50,000; bilirubin </= 3.0 gm/dL. Except for patients with liver metastases: total bilirubin </= 5 ULN.
- Women of childbearing potential must have a negative baseline blood pregnancy test. Women and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study.
- 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.
- Patients may not be receiving any other experimental agents that are not FDA approved.
- Ability to understand and willingness to sign a written consent document.
- Treatment on this study may begin within 24 hours after Phase 0 dose of Temsirolimus.
- Pregnant or lactating women.
- Patients with creatinine clearance <10 mL/min
- Patients with a known hypersensitivity to any of the components or metabolites of the drug products.
- Patients with major surgery within 30 days prior to entering study.
- Patients on inhibitors or inducers of CYP3A4 metabolism will have the inhibitors or inducers stopped unless clinically contraindicated. See section 6 (Concomitant Medications) and Appendix E of the protocol for details.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877773
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Daniel Karp, MD
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 7, 2009
||March 29, 2013
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer with genetic mutation
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Physiological Effects of Drugs