A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma. - Tabular View

Tracking Information

First Received Date ^ICMJE

February 13, 2004

Last Updated Date

November 4, 2009

Start Date ^ICMJE

February 2004

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST) [ Time Frame: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Response Rate

Change History

Complete list of historical versions of study NCT00077974 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to Tumor Progression (TTP) [ Time Frame: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter ] [ Designated as safety issue: No ]
Duration of Response (DR) [ Time Frame: Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer ] [ Designated as safety issue: No ]
Overall Survival (OS) [ Time Frame: From start of study treatment until death ] [ Designated as safety issue: No ]
Progression-free Survival (PFS) [ Time Frame: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death ] [ Designated as safety issue: No ]
Percent Chance of Patient Survival [ Time Frame: From start of study treatment until death ] [ Designated as safety issue: No ]
Observed Plasma Trough Concentrations of Sunitinib [ Time Frame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ] [ Designated as safety issue: No ]
Observed Plasma Trough Concentrations of Sunitinib Metabolite [ Time Frame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ] [ Designated as safety issue: No ]
Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite [ Time Frame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ] [ Designated as safety issue: No ]
Dose Corrected Plasma Trough Concentrations of Sunitinib [ Time Frame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ] [ Designated as safety issue: No ]
Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite [ Time Frame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ] [ Designated as safety issue: No ]
Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite [ Time Frame: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Other anti-tumor efficacy survival safety

Descriptive Information

Brief Title ^ICMJE

A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.

Official Title ^ICMJE

A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

Brief Summary

To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Carcinoma, Renal Cell

Intervention ^ICMJE

Drug: SU011248

Study Arms / Comparison Groups

Publications *

Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006 Jun 7;295(21):2516-24.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

106

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Cytokine refractory metastatic renal cell carcinoma with clear cell component
Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy
Prior nephrectomy

Exclusion Criteria:

Prior treatment with any systemic therapy other than 1 cytokine therapy
History of or known brain metastases
Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00077974

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer Inc

Study ID Numbers ^ICMJE

A6181006

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP