A Phase 1 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Solid Tumors

Pfizer1 site in 1 country49 target enrollmentJuly 2004

ConditionsAdvanced Solid Tumors Non Small Cell Lung Cancer

Interventionssunitinib docetaxel

Drugssunitinib docetaxel

Overview

Phase: Phase 1
Intervention: sunitinib
Conditions: Advanced Solid Tumors
Sponsor: Pfizer
Enrollment: 49
Locations: 1
Primary Endpoint: Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2004

End Date

November 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

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