A Phase I Study of Temsirolimus in Combination With Metformin in Advanced Solid Tumours
OBJECTIVES:
Primary
- To establish the maximum tolerated dose and recommended phase II dose of metformin
hydrochloride when administered with temsirolimus in patients with advanced solid
cancers or lymphoma.
Secondary
- To determine the toxicity and safety, with particular reference to glucose and lipid
deregulation, of this regimen in these patients.
- To assess antitumor activity, including tumor response rate and time to progression, in
patients treated with this regimen.
OUTLINE: This is a dose-escalation study of metformin hydrochloride.
Patients receive oral metformin once, twice, or three times daily on days 1-28 and
temsirolimus IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Interventional
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose and recommended phase II dose of metformin hydrochloride when administered with temsirolimus
Yes
Mary Mackenzie, MD
Principal Investigator
London Regional Cancer Program at London Health Sciences Centre
United States: Federal Government
CAN-LRCC-UWOREB13877
NCT00659568
March 2008
August 2010
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