Study of SU011248 in Patients With Advanced Kidney Cancer - Full Text View

Purpose

To determine the objective tumor response of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks and 2 weeks rest, repeated every 6 weeks in patients with metastatic Renal Cell Cancer (RCC).

Condition	Intervention	Phase
Carcinoma, Renal Cell	Drug: SU011248 capsule	Phase II

MedlinePlus related topics:

Cancer Kidney Cancer

Drug Information available for:

Sunitinib Sunitinib malate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	Phase II Study Of Single-Agent SU011248 In The Treatment Of Patients With Renal Cell Carcinoma

Further study details as provided by Pfizer:

Primary Outcome Measures:

Overall objective response rate (ORR) [ Time Frame: 31-Oct-2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: 31-Oct-2008 ] [ Designated as safety issue: Yes ]
Pharmacokinetic (PK) [ Time Frame: 31-Oct-2008 ] [ Designated as safety issue: No ]
Quality of Life (QOL) [ Time Frame: 31-Oct-2008 ] [ Designated as safety issue: No ]
Overall Survival (OS) [ Time Frame: 31-Oct-2008 ] [ Designated as safety issue: No ]
Time to Tumor Progression (TTP) [ Time Frame: 31-Oct-2008 ] [ Designated as safety issue: No ]
Pharmacodynamic (PD) [ Time Frame: 31-Oct-2008 ] [ Designated as safety issue: No ]
Duration of Response (DR) [ Time Frame: 31-Oct-2008 ] [ Designated as safety issue: No ]
Time to Tumor Response (TTR) [ Time Frame: 31-Oct-2008 ] [ Designated as safety issue: No ]
Progression -free survival (PFS) [ Time Frame: 31-Oct-2008 ] [ Designated as safety issue: No ]

Enrollment:	51
Study Start Date:	December 2005
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: SU011248 capsule 50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops

Eligibility

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

Criteria

Inclusion Criteria:

Histologically proven renal cell carcinoma with metastases with a component of clear cell histology

Exclusion Criteria:

Any cellular therapy (LAK, TIL, DC), any vaccine therapy, mini-transplantation, or systemic molecular-targeting therapy for RCC.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254540

Locations


Japan
	Pfizer Investigational Site
	Fukuoka, Japan
	Pfizer Investigational Site
	Akita, Japan
	Pfizer Investigational Site
	Osaka, Japan
	Pfizer Investigational Site
	Tokushima, Japan
	Pfizer Investigational Site
	Yamagata, Japan

Japan, Hokkaido
	Pfizer Investigational Site
	Sapporo, Hokkaido, Japan

Japan, Ibaragi
	Pfizer Investigational Site
	Tsukuba, Ibaragi, Japan

Japan, Osaka
	Pfizer Investigational Site
	Osakasayama, Osaka, Japan

Japan, Shizuoka
	Pfizer Investigational Site
	Sunto-gun, Shizuoka, Japan
	Pfizer Investigational Site
	Hamamatsu, Shizuoka, Japan

Japan, Tokyo
	Pfizer Investigational Site
	Chuo-ku, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181072
First Received:	November 14, 2005
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00254540
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

Ph2, RCC, SU011248, SUNITINIB

Study placed in the following topic categories:

Urogenital Neoplasms

Renal cancer

Urologic Neoplasms

Kidney cancer

Carcinoma

Urologic Diseases

Kidney Neoplasms

Sunitinib

Carcinoma, Renal Cell

Kidney Diseases

Adenocarcinoma

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

Antineoplastic Agents

Growth Substances

Therapeutic Uses

Physiological Effects of Drugs

Growth Inhibitors

Angiogenesis Modulating Agents

Angiogenesis Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 06, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00254540