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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00618124
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : May 3, 2010
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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

Condition or disease Intervention/treatment Phase
Solid Tumors Breast Cancer Neoplasms Drug: SU011248; Capecitabine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Safety And Pharmacokinetic Study Of SU011248 And Capecitabine In Patients With Advanced Solid Tumors
Study Start Date : May 2005
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Sutent, sunitinib, SU11248, Xeloda

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00618124

United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202
United States, New Mexico
Pfizer Investigational Site
Albuqurque, New Mexico, United States, 87131
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc. Identifier: NCT00618124     History of Changes
Other Study ID Numbers: A6181044
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: May 3, 2010
Last Verified: April 2010

Keywords provided by Pfizer:
solid tumor malignancy, SU011248, sunitinib, capecitabine, Phase 1

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors