Study Evaluating the Efficacy & Pharmacokinetics of Temsirolimus(CCI-779) in Subjects With Advanced Renal Cell Carcinoma

This study is ongoing, but not recruiting participants.

First Received: June 28, 2007 Last Updated: December 1, 2008 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00494091

Purpose

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

Condition	Intervention	Phase
Advanced Renal Cell Carcinoma	Drug: Temsirolimus (CCI-779)	Phase II

Drug Information available for: CCI 779

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Safety/Efficacy Study, Single Group Assignment, Treatment, Uncontrolled
Official Title:	Phase 2, Non Randomized, Open Label Study of Temsirolimus (CCI-779) in Subjects With Advanced Renal Cell Carcinoma (RCC)

Further study details as provided by Wyeth:

Primary Outcome Measures:

Rate of adverse events and clinical benefit rate (complete response + partial response >=24 weeks) [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression free survival, duration of response, overall survival, pharmacokinetics [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	June 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Temsirolimus (CCI-779) 20 mg/m2 IV TEMSR (Japan, n=6), 25 mg IV weekly (all other pts)
B: Experimental	Drug: Temsirolimus (CCI-779) 20 mg/m2 IV TEMSR (Japan, n=6), 25 mg IV weekly (all other pts)

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main 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.

Main 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).

Other criteria apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494091

Locations

China

Beijing, China, 100021

Beijing, China, 100034

Beijing, China, 100036

Beijing, China, 100730

Shanghai, China, 200032

Shanghai, China, 200128

Nanjing, China, 210002

Shanghai, China, 200127
Japan

Yamagata, Japan, 9909585

Ibaraki, Japan, 3058576

Chiba, Japan, 2608717

Fukuoka, Japan, 8128582

Hyogo, Japan, 6500017

Kagoshima, Japan, 8908520

Hokkaido, Japan, 608543

Chiba, Japan, 2608677

Shizuoka, Japan, 4313192

Gunma, Japan, 3718511

Kagawa, Japan, 7610793

Tokyo, Japan, 1608582

Kyoto, Japan, 6028566

Tokyo, Japan, 1738606

Osaka, Japan, 5378511

Fukuoka, Japan, 8300011

Okayama, Japan, 7008558

Nara, Japan, 6348522
Korea, Republic of

Seoul, Korea, Republic of, 135-710

Seoul, Korea, Republic of, 138-736

Seoul, Korea, Republic of, 110-744

Seoul, Korea, Republic of, 120-752

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For China: medinfo@wyeth.com

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3066K1-2217
Study First Received:	June 28, 2007
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00494091 History of Changes
Health Authority:	China: Ministry of Health; China: State Food and Drug Administration; Japan: Ministry of Health, Labor and Welfare; Korea: Food and Drug Administration

Study placed in the following topic categories:

Urinary Tract Neoplasm
Kidney Cancer
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell

Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell

Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on March 16, 2009