Clinical trial NCT00494091: Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma
Official title: Phase 2, Non Randomized, Open Label Study Of Temsirolimus (CCI-779) In Subjects With Advanced Renal Cell Carcinoma (RCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Renal Cell Carcinoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-29
Enrollment: 82
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants With Clinical Benefit
timeFrame: Baseline Up to 4 years
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Baseline Up to 4 years
measure: Percentage of Participants With Objective Response
timeFrame: Baseline Up to 4 years
measure: Duration of Response
timeFrame: Baseline Up to 4 years
measure: Time to Treatment Failure (TTF)
timeFrame: Baseline Up to 4 years
measure: Overall Survival (OS)
timeFrame: Baseline Until Death (Up to 4 years)
Other outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
measure: Area Under the Concentration-Time Curve (AUC)
timeFrame: 0 hours (pre-dose), 0.5 hours, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
measure: Clearance (CLss) of Temsirolimus
timeFrame: 0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
measure: Volume of Distribution at Steady State (Vss) of Temsirolimus
timeFrame: 0 hours (pre-dose), 0.5, 1, 2, 6, 24, 72, and 96 hours during Week 1 and 4 of treatment
Locations:
city: Nanjing
country: China
facility: Pfizer Investigational Site
state: Jiangsu
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Chiba
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Gunma
country: Japan
facility: Pfizer Investigational Site
city: Hokkaido
country: Japan
facility: Pfizer Investigational Site
city: Ibaraki
country: Japan
facility: Pfizer Investigational Site
city: Kagawa
country: Japan
facility: Pfizer Investigational Site
city: Kagoshima
country: Japan
facility: Pfizer Investigational Site
city: Kyoto
country: Japan
facility: Pfizer Investigational Site
city: Nara
country: Japan
facility: Pfizer Investigational Site
city: Okayama
country: Japan
facility: Pfizer Investigational Site
city: Osaka
country: Japan
facility: Pfizer Investigational Site
city: Shizuoka
country: Japan
facility: Pfizer Investigational Site
city: Tokyo
country: Japan
facility: Pfizer Investigational Site
city: Yamagata
country: Japan
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: