Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib

Completed · Phase 3

Conditions studied: Renal Cell Carcinoma

In brief

This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.

Key facts

Study ID

NCT00474786

Run by

Pfizer

People needed

512

Starts

2007-09-01

Expected to finish

2013-01-01

Last updated by the study team

2013-11-21

Who can join

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

You may qualify if…

• Histologically confirmed diagnosis of mRCC (regardless of histology or nephrectomy status) with well-documented Radiological PD by RECIST criteria or clinical PD as judged by the investigator while receiving first-line sunitinib therapy. Subjects must have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously).
• At time of randomization, at least 2 weeks since prior treatment with sunitinib, palliative radiation therapy, and/or surgery.
• At time of randomization, there must be at least 1 measurable lesion per RECIST. Lesions that have been previously irradiated or embolized cannot be selected as target lesions.
• More criteria apply

You may not qualify if…

• Metastatic CNS from RCC.
• Subjects who discontinued Sutent therapy due specifically to intolerance.
• Prior systemic therapy for mRCC other than sunitinib.
• Active ketonuria, secondary to poorly controlled diabetes mellitus
• More criteria apply

Where it is running

• Pfizer Investigational Site — La Jolla, California, United States
• Pfizer Investigational Site — La Jolla, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Orange, California, United States
• Pfizer Investigational Site — Riverside, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Meriden, Connecticut, United States
• Pfizer Investigational Site — Municie, Indiana, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — Metairie, Louisiana, United States
• Pfizer Investigational Site — Baltimore, Maryland, United States
• Pfizer Investigational Site — Bethesda, Maryland, United States
• Pfizer Investigational Site — Tupelo, Mississippi, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Cleveland, Ohio, United States
• Pfizer Investigational Site — Oklahoma City, Oklahoma, United States
• Pfizer Investigational Site — Tulsa, Oklahoma, United States
• Pfizer Investigational Site — Austin, Texas, United States
• Pfizer Investigational Site — Dallas, Texas, United States
• Pfizer Investigational Site — Dallas, Texas, United States
• Pfizer Investigational Site — San Antonio, Texas, United States
• Pfizer Investigational Site — Salt Lake City, Utah, United States
• Pfizer Investigational Site — Salt Lake City, Utah, United States
• Pfizer Investigational Site — Duarte, California, United States

Full record on ClinicalTrials.gov

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