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

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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Contacts


Contact: Trial Manager		clintrialparticipation@wyeth.com

Locations


China
		Recruiting
	Beijing, China, 100021
		Recruiting
	Beijing, China, 100034
		Recruiting
	Beijing, China, 100036
		Recruiting
	Shanghai, China, 200128
		Recruiting
	Shanghai, China, 200032
		Recruiting
	Nanjing, China, 210002

Japan
		Active, not recruiting
	Yamagata, Japan, 9909585
		Active, not recruiting
	Nara, Japan, 6348522
		Active, not recruiting
	Chiba, Japan, 2608717
		Active, not recruiting
	Hokkaido, Japan, 608543
		Active, not recruiting
	Hyogo, Japan, 6500017
		Active, not recruiting
	Kagoshima, Japan, 8908520
		Active, not recruiting
	Fukuoka, Japan, 8128582
		Active, not recruiting
	Ibaraki, Japan, 3058576
		Active, not recruiting
	Chiba, Japan, 2608677
		Active, not recruiting
	Shizuoka, Japan, 4313192
		Active, not recruiting
	Gunma, Japan, 3718511
		Active, not recruiting
	Kagawa, Japan, 7610793
		Active, not recruiting
	Tokyo, Japan, 1738606
		Active, not recruiting
	Kyoto, Japan, 6028566
		Active, not recruiting
	Osaka, Japan, 5378511
		Active, not recruiting
	Tokyo, Japan, 1608582
		Active, not recruiting
	Fukuoka, Japan, 8300011
		Active, not recruiting
	Okayama, Japan, 7008558

Korea, Republic of
		Active, not recruiting
	Seoul, Korea, Republic of, 120-752
		Active, not recruiting
	Seoul, Korea, Republic of, 135-710
		Active, not recruiting
	Seoul, Korea, Republic of, 138-736
		Active, not recruiting
	Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

Principal Investigator:	Trial Manager	For China: medinfo@wyeth.com

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3066K1-2217
First Received:	June 28, 2007
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00494091
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:

Urologic Diseases

Kidney Neoplasms

Carcinoma, Renal Cell

Urogenital Neoplasms

Renal cancer

Kidney Diseases

Kidney cancer

Urologic Neoplasms

Adenocarcinoma

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 06, 2008

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