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

Pfizer1 site in 1 country77 target enrollmentMay 2005

ConditionsSolid Tumors Breast Cancer Neoplasms

InterventionsSU011248; Capecitabine

DrugsSU011248; Capecitabine

Overview

Phase: Phase 1
Intervention: SU011248; Capecitabine
Conditions: Solid Tumors
Sponsor: Pfizer
Enrollment: 77
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

July 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

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)

Exclusion Criteria

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

Arms & Interventions

A

Intervention: SU011248; Capecitabine

Outcomes

Primary Outcomes

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.

Time Frame: From Screening until disease progression or discontinuation of the study

Secondary Outcomes

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)