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Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Cancer

NCT ID: NCT00712504

Last Updated: 2008-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-11-30

Brief Summary

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This study is determining the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel (Taxotere). Several dosing regimens will be tested in patients with advanced solid tumors, including non small cell lung cancer.

Detailed Description

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Conditions

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Advanced Solid Tumors Non Small Cell Lung Cancer

Keywords

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advanced solid tumors, non small cell lung cancer, pulmonary neoplasms, sunitinib (SUTENT), docetaxel (Taxotere), Angiogenesis Inhibitors

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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1

SU011248 in combination with docetaxel

Group Type EXPERIMENTAL

sunitinib

Intervention Type DRUG

25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in two different dosing regimens: schedule 2/1 (2 weeks on, 1 week off) and schedule 4/2 (4 weeks on, 2 weeks off)

docetaxel

Intervention Type DRUG

60, 75, and 100 mg/m2 docetaxel administered every 21 days as a 1-hr IV infusion

Interventions

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sunitinib

25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in two different dosing regimens: schedule 2/1 (2 weeks on, 1 week off) and schedule 4/2 (4 weeks on, 2 weeks off)

Intervention Type DRUG

docetaxel

60, 75, and 100 mg/m2 docetaxel administered every 21 days as a 1-hr IV infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Advanced solid tumor malignancy ECOG 0 or 1

Exclusion Criteria

Prior treatment with with high-dose chemotherapy requiring stem cell rescue Prior irradiation to ≥25% of the bone marrow (e.g. whole pelvis=25%) Patients with centrally located lung lesions unless recently treated with radiotherapy
Minimum Eligible Age

18 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

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Nashville, Tennessee, United States

Site Status

Pfizer Investigational Site

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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A6181035

Identifier Type: -

Identifier Source: org_study_id