Study of SU011248 in Patients With Advanced Kidney Cancer

NCT ID: NCT00254540

Last Updated: 2010-02-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2009-02-28

Brief Summary

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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

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Conditions

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Carcinoma, Renal Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SU-011248 capsule

Group Type EXPERIMENTAL

SU011248 capsule

Intervention Type DRUG

50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops

Interventions

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SU011248 capsule

50mg, PO on day 28 of each 42 day cycle, until progression or unacceptable toxicity develops

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Akita, Akita, Japan

Site Status

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Site Status

Pfizer Investigational Site

Tsukuba, Ibaragi, Japan

Site Status

Pfizer Investigational Site

Osaka, Osaka, Japan

Site Status

Pfizer Investigational Site

Sayama, Osaka, Japan

Site Status

Pfizer Investigational Site

Hamamatsu, Shizuoka, Japan

Site Status

Pfizer Investigational Site

Sunto-gun, Shizuoka, Japan

Site Status

Pfizer Investigational Site

Tokushima, Tokushima, Japan

Site Status

Pfizer Investigational Site

Chuo-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Yamagata, Yamagata, Japan

Site Status

Pfizer Investigational Site

Fukuoka, , Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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A6181072

Identifier Type: -

Identifier Source: org_study_id

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