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

NCT00077974

Last updated date
Study Location
Pfizer Investigational Site
Duarte, California, 91010-3000, United States
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
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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


- 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

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Advanced Information
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 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
50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity
Other Name: Sunitinib, SUTENT
Study Arms  ICMJE Experimental: 1
Intervention: Drug: SU011248
Publications *

*   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: August 26, 2005)
106
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
100
Actual Study Completion Date  ICMJE September 2008
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00077974
Other Study ID Numbers  ICMJE A6181006
Has Data Monitoring Committee Yes
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 October 2010

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