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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00618124

Purpose

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	Intervention	Phase
Breast Cancer Neoplasms	Drug: SU011248; Capecitabine	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Capecitabine Sunitinib malate Sunitinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 1 Safety And Pharmacokinetic Study Of SU011248 And Capecitabine In Patients With Advanced Solid Tumors

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	77
Study Start Date:	May 2005
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618124

Locations

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

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181044
Study First Received:	February 1, 2008
Last Updated:	November 22, 2008
ClinicalTrials.gov Identifier:	NCT00618124 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

solid tumor malignancy, SU011248, sunitinib, capecitabine, Phase 1

Study placed in the following topic categories:

Antimetabolites
Capecitabine
Skin Diseases
Sunitinib

Breast Neoplasms
Angiogenesis Inhibitors
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Breast Neoplasms

Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Sunitinib
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009