Temsirolimus In Phase 0

Completed · Early Phase 1

Conditions studied: Advanced Cancer

In brief

The goal of this clinical research trial is to study the effects of the FDA-approved drug, temsirolimus, using a new type of clinical study design called a "Phase 0." This type of study may be able to predict if a drug can affect cancer and may be able to prevent potentially useful study drugs from being discarded before they are fully tested. The purpose of the study is not to treat the cancer, but to help improve general cancer treatment knowledge.

Key facts

Study ID

NCT01417065

Run by

M.D. Anderson Cancer Center

People needed

15

Starts

2010-08-01

Last updated by the study team

2014-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with advanced or metastatic cancer, preferably with tumor easily accessible for biopsy.
• Patients should be at least four weeks or 5 half lives from the last day of chemotherapy, antibody or other biological therapy, whichever is shorter.
• Patients should preferably be undergoing screening for 2007-0668, 2008-0384, 2008-0425, and 2008-0827 (currently active Phase I trials involving temsirolimus). However, patients may also be allowed on protocol if they are undergoing screening for any study.

You may not qualify if…

• Pregnant or lactating women.
• Patients with a known hypersensitivity to any of the components or metabolites of the drug products.
• Patients with a known bleeding diathesis which would prevent safely obtaining a biopsy if a biopsy is indicated.
• Patients who are less than 18 years of age.

Where it is running

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

Full record on ClinicalTrials.gov

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