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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Renal Cell Carcinoma

Treatments

Drug: Sorafenib

Drug: temsirolimus (Torisel)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00474786

3066K1-404

B1771003

Details and patient eligibility

About

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.

Enrollment

512 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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