Assessment Of Safety And Efficacy Of SU11248 In Patients With Metastatic Colorectal Cancer Who Have Failed Selected Previous Treatments.

This study has been completed.

First Received on February 13, 2004. Last Updated on January 9, 2007 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00077987

Purpose

Assessment of safety and efficacy of SU11248 in patients with metastatic colorectal cancer who have failed selected previous treatments.

Condition	Intervention	Phase
Colorectal Neoplasms	Drug: SU011248	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study Of SU011248 In Patients With Metastatic Colorectal Cancer Who Have Previously Failed Treatment With Irinotecan, Oxaliplatin, And A Fluoropyrimidine, With And Without Bevacizumab

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Anti-tumor efficacy

Secondary Outcome Measures:

Tumor control survival safety

Estimated Enrollment:	84
Study Start Date:	December 2003
Estimated Study Completion Date:	April 2005

Eligibility

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

Criteria

Inclusion Criteria:

Metastatic colorectal cancer
Failed selected cancer therapies in the past.

Exclusion Criteria:

Prior treatment with tyrosine kinase inhibitors or VEGF inhibitors other than bevacizumab.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077987

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00077987 History of Changes
Other Study ID Numbers:	A6181003
Study First Received:	February 13, 2004
Last Updated:	January 9, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

Rectal Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012