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

Pfizer77 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors Breast Cancer Neoplasms

Interventions

SU011248; CapecitabineDRUG

Dose finding study using SU011248 daily by oral capsule in a continuous regimen or administered for 4 out of every 6 weeks (Schedule 4/2) or 2 out of every 3 weeks (Schedule 2/1), with capecitabine administered 2 out of every 3 weeks until progression or unacceptable toxicity.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (3)

Pfizer Investigational Site

Indianapolis, Indiana, United States

Pfizer Investigational Site

Albuqurque, New Mexico, United States

Pfizer Investigational Site

Nashville, Tennessee, United States

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

Time frame: 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

Time frame: From screening until disease progression or discontinuation of the study

Data from ClinicalTrials.gov

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