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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
20 mg/m2 IV TEMSR weekly (Japan, n=6)
25 mg IV TEMSR weekly (all other pts)
Pfizer Investigational Site
Nanjing, Jiangsu, China
Pfizer Investigational Site
Beijing, China
Percentage of Participants With Clinical Benefit
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).
Time frame: Baseline Up to 4 years
Progression-free Survival (PFS)
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.
Time frame: Baseline Up to 4 years
Percentage of Participants With Objective Response
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.
Time frame: Baseline Up to 4 years
Duration of Response
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 frame: Baseline Up to 4 years
Time to Treatment Failure (TTF)
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.
Time frame: Baseline Up to 4 years
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Pfizer Investigational Site
Beijing, China
Pfizer Investigational Site
Beijing, China
Pfizer Investigational Site
Shanghai, China
Pfizer Investigational Site
Shanghai, China
Pfizer Investigational Site
Chiba, Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Gunma, Japan
Pfizer Investigational Site
Hokkaido, Japan
...and 14 more locations
Overall Survival (OS)
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).
Time frame: Baseline Until Death (Up to 4 years)