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

Phase 1

Completed

• Conditions: Advanced Solid Tumors; Non Small Cell Lung Cancer
• Interventions: Drug: sunitinib; Drug: docetaxel

• Registration Number: NCT00712504
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-07
• Study First Posted: 2008-07-10
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-07
• Last Update Posted: 2008-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	sunitinib	SU011248 in combination with docetaxel
1	docetaxel	SU011248 in combination with docetaxel

Primary Outcome Measures

Name	Time	Method
Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities	November 2007

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of SU011248 (and its active metabolite, SU012662), and docetaxel.	November 2007
Objective disease response	November 2007

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Madison, Wisconsin, United States