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

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

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 Overview

• Status: Completed
• Conditions: Neoplasms; Breast Cancer; Solid Tumors
• Intervention / Treatment: Drug: SU011248; Capecitabine

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Pfizer Investigational Site
  • New Mexico
    • Albuqurque, New Mexico, United States, 87131
      • Pfizer Investigational Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	Drug: SU011248; Capecitabine; 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.; Other Names: Sutent, sunitinib, SU11248, Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: February 1, 2008
• First Submitted That Met QC Criteria: February 5, 2008
• First Posted (Estimate): February 18, 2008

Study Record Updates

• Last Update Posted (Estimate): May 3, 2010
• Last Update Submitted That Met QC Criteria: April 29, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: solid tumor malignancy, SU011248, sunitinib, capecitabine, Phase 1
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Capecitabine; Sunitinib
• Other Study ID Numbers: A6181044