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Phase II Efficacy Study of AZD6244 in Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00514761
First received: August 9, 2007
Last updated: August 12, 2014
Last verified: August 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Xeloda
Drug: Capecitabine
oral tablet
Other Name: Xeloda
Experimental: 2
AZD6244
Drug: AZD6244
oral vial
Other Name: ARRY-142886

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00514761     History of Changes
Other Study ID Numbers: D1532C00011
Study First Received: August 9, 2007
Last Updated: August 12, 2014
Health Authority: Sweden: Medical Products Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Capecitabine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014