Phosphatidylinositol 3 Kinase and Mammalian Target of Rapamycin (PI3K-mTOR) in Advanced Cancer Patients

Stopped early · Phase 1/Phase 2

Conditions studied: Advanced Cancers

In brief

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.

Key facts

Study ID

NCT00877773

Run by

M.D. Anderson Cancer Center

People needed

44

Starts

2009-04-01

Expected to finish

2014-06-01

Last updated by the study team

2016-08-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 upper limit of normal (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.

You may not qualify if…

• 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.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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