Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma

Pfizer

Status and phase

Completed

Phase 2

Conditions

Advanced Renal Cell Carcinoma

Treatments

Drug: Temsirolimus (CCI-779)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00494091

3066K1-2217

B1771002

Details and patient eligibility

About

This is a study to evaluate the safety, efficacy and pharmacokinetics of temsirolimus in Asian patients with advanced renal cell carcinoma. The trial is only being conducted in Japan, Korea, and China.

Enrollment

82 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC. The American Joint Committee on Cancer (AJCC) staging and classification criteria will be used.
ECOG performance status of 0-1.
At least one measurable lesion per RECIST.
Age greater than or equal to 20 years.
Japanese, Chinese, or Korean ethnicity.

Exclusion criteria

CNS metastases at screening or history or CNS metastases.
Prior targeted, chemotherapeutic, cytokine-based, or other investigational agents for the treatment of RCC within 4 weeks before first dose of test article. Subjects must have documented objective progressive disease after any prior systemic RCC treatment and have recovered to grade 1 or lower toxicities from effects of prior systemic therapy for RCC.
In past 5 years, other prior malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ).