Study of SU011248 in Patients With Advanced Kidney Cancer

NCT00254540

Last updated date
Study Location
Pfizer Investigational Site
Sapporo, Hokkaido, , Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of SU011248 in Patients With Advanced Kidney Cancer
Official Title  ICMJE Phase II Study Of Single-Agent SU011248 In The Treatment Of Patients With Renal Cell Carcinoma
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Renal Cell
Intervention  ICMJE Drug: SU011248 capsule
50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops
Study Arms  ICMJE Experimental: SU-011248 capsule
Intervention: Drug: SU011248 capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2005)
51
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00254540
Other Study ID Numbers  ICMJE A6181072
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2010

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