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

Recruitment & Eligibility

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).

Study & Design

Arm && Interventions

Group	Intervention	Description
A.	Temsirolimus (CCI-779)	-
B.	Temsirolimus (CCI-779)	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Clinical Benefit	Baseline Up to 4 years	Clinical benefit: confirmed complete response (CR) or partial response (PR) or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and nontarget lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	Baseline Up to 4 years	Median time from the date of enrollment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Percentage of Participants With Objective Response	Baseline Up to 4 years	Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria In Solid Tumors (RECIST). CR is disappearance of all target lesions. PR shows at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
Duration of Response	Baseline Up to 4 years	Time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest sum longest diameters (LD) recorded since enrollment.
Time to Treatment Failure (TTF)	Baseline Up to 4 years	TTF is defined as the time from the date of enrollment to the date of the first documentation of PD, the date of treatment discontinuation except completion of treatment, or date of death due to cancer.
Overall Survival (OS)	Baseline Until Death (Up to 4 years)	Time in months from the date of enrollment to date of death due to any cause. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

Recruitment & Eligibility