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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Solid Tumors; Breast Cancer; Neoplasms

Intervention: SU011248; Capecitabine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

To evaluate the pharmacokinetics of SU011248 and capecitabine when these drugs are co-administered

To preliminarily assess the antitumor activity of SU011248 and capecitabine in patients with measurable disease

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Pfizer Investigational Site, Indianapolis, Indiana 46202, United States

Pfizer Investigational Site, Albuqurque, New Mexico 87131, United States

Pfizer Investigational Site, Nashville, Tennessee 37203, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: May 2005
Last updated: April 29, 2010

Page last updated: August 23, 2015

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