Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00130897

Purpose

The primary objective of this protocol is to provide access to SU011248 treatment for patients with metastatic RCC who are ineligible for participation in ongoing SU011248 clinical studies and have the potential to derive clinical benefit from treatment with SU011248 based on the judgment of the investigator.

Condition	Intervention	Phase
Carcinoma, Renal Cell	Drug: sunitinib malate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A SU011248 Expanded Access Protocol For Systemic Therapy Of Patients With Metastatic Renal Cell Carcinoma Who Are Ineligible For Participation In Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248

Resource links provided by NLM:

Drug Information available for: Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To provide access to SU011248 treatment for patients with metastatic Renal Cell Carcinoma [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to Tumor Progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Responses in the population with measurable disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Safety [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	4572
Study Start Date:	June 2005
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A Sutent 25, 37.5, or 50 mg daily	Drug: sunitinib malate sutent, 25, 37.5, or 50 mg daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

renal cell carcinoma that is not amendable to standard therapy with curative intent

Exclusion Criteria:

current treatment in another therapeutic clinical trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130897

Show 275 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181037
Study First Received:	August 14, 2005
Last Updated:	January 15, 2010
ClinicalTrials.gov Identifier:	NCT00130897 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site

Urologic Diseases
Kidney Neoplasms
Sunitinib
Therapeutic Uses
Carcinoma, Renal Cell
Growth Inhibitors
Angiogenesis Modulating Agents
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 04, 2010