A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Administered Together

Phase 1

Completed

• Conditions: Solid Tumors; Breast Cancer; Neoplasms
• Interventions: Drug: SU011248; Capecitabine

• Registration Number: NCT00618124
• Lead Sponsor: Pfizer

Brief Summary

This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with capecitabine in patients with advanced solid tumors

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2008-02-01
• Study First Submitted QC: 2008-02-05
• Study First Posted: 2008-02-18
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-29
• Last Update Posted: 2010-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Patients with diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists
• Patient has good performance status (ECOG 0 or 1)

Read More

Exclusion Criteria

• Prior treatment with either SU011248 or capecitabine.
• Hypertension that cannot be controlled by medications

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	SU011248; Capecitabine	-

Primary Outcome Measures

Name	Time	Method
To determine the maximally tolerated dose of SU011248 (dosed continuously or on a 4/2 or 2/1 Schedule) when given in combination with capecitabine.	From Screening until disease progression or discontinuation of the study

Secondary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetics of SU011248 and capecitabine when these drugs are co-administered	From Cycle 1, Day 1 until discontinuation of the study
To preliminarily assess the antitumor activity of SU011248 and capecitabine in patients with measurable disease	From screening until disease progression or discontinuation of the study

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Nashville, Tennessee, United States