Phase II Efficacy Study of AZD6244 in Colorectal Cancer - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00514761

Purpose

The purpose of the study is to assess if there is benefit when using AZD6244 in the treatment if metastatic colorectal cancer in comparison with another treatment called capecitabine. This study will also assess how safe and well tolerated AZD6244 is.

Condition	Intervention	Phase
Metastatic Colorectal Cancer	Drug: AZD6244 Drug: Capecitabine	Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Capecitabine ARRY 142886

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Open, Randomized Study to Assess the Efficacy and Safety of AZD6244 vs Capecitabine (Xeloda) in Patients With Colorectal Cancer Who Have Failed One or Two Prior Chemotherapeutic Regimens.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Progression event count [ Time Frame: assessed after each visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

safety and tolerability [ Time Frame: assessed at each visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	64
Study Start Date:	September 2006
Study Completion Date:	July 2007

Arms	Assigned Interventions
1: Active Comparator Xeloda	Drug: Capecitabine oral tablet
2: Experimental AZD6244	Drug: AZD6244 oral vial

Eligibility

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

Criteria

Inclusion Criteria:

colorectal cancer
require treatment but have failed one or two previous chemotherapeutic regimens that must have included oxaliplatin and/or irinotecan
have World Health Organisation (WHO) performance status 0-2 and life expectancy > 12 weeks

Exclusion Criteria:

previous therapy with EGFR inhibitor, MEK inhibitor or capecitabine
any recent surgery, unhealed surgical incision or severe concomitant condition which makes it undesirable for the patient to participate in the study
nausea and vomiting, chronic gastrointestinal disease or significant bowel resection that would preclude adequate absorption

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514761

Locations

Brazil
Research Site
Sao Paulo, Brazil
Research Site
Rio de Janeiro, Brazil
Research Site
Goiania, Brazil

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Clive Morris, MD	AstraZeneca
Study Director:	Gill Pover, MD	AstraZeneca
Study Director:	Lance Smith	AstraZeneca

More Information

Study ID Numbers:	D1532C00011
Study First Received:	August 9, 2007
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00514761
Health Authority:	Sweden: Medical Products Agency; France: Afssaps - French Health Products Safety Agency; Spain: Spanish Agency of Medicines; Hungary: National Institute of Pharmacy; Slovakia: State Institute for Drug Control; Korea: Food and Drug Administration

Keywords provided by AstraZeneca:

colorectal cancer
AZD6244

Study placed in the following topic categories:

Capecitabine
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009