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Study of SU011248 in Patients With Advanced Kidney Cancer - Article


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Zidovudine Capsule

Azidothymidine Capsule; AZT Capsule; Compound S Capsule; Retrovir Capsule

Clinical Trial: Study of SU011248 in Patients With Advanced Kidney Cancer

This study is not yet open for patient recruitment.
Verified by Pfizer December 2005

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

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 RCC.
Condition Intervention Phase
Renal Cell Carcinoma
  Drug: SU011248 capsule
 Phase II

MedlinePlus related topics:  Cancer;   Kidney Cancer

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, 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 Outcomes: Efficacy
Secondary Outcomes: Safety, PK, PD, QOL
Expected Total Enrollment:  51

Study start: December 2005

Eligibility

Ages Eligible for Study:  20 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00254540


Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

More Information

Study ID Numbers:  A6181072
Last Updated:  December 9, 2005
Record first received:  November 14, 2005
ClinicalTrials.gov Identifier:  NCT00254540
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2006-01-10


Source: ClinicalTrials.gov
Cache Date: January 11, 2006


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Page Updated: June 1, 2005
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