Phase II Efficacy Study of AZD6244 in Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514761
• Other study ID #: D1532C00011
• Status: Completed
• Phase: Phase 2
• First received: August 9, 2007
• Last updated: August 12, 2014
• Start date: September 2006
• Est. completion date: July 2008

Study information

• Verified date: August 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of MedicinesHungary: National Institute of PharmacySlovakia: State Institute for Drug ControlKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• AZD6244
oral vial
• Capecitabine
oral tablet

Locations

Country	Name	City	State
Brazil	Research Site	Goiania
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression event count		assessed after each visit	Yes
Secondary	safety and tolerability		assessed at each visit	Yes

External Links

•   Link
•   CSR-D1532C00011.pdf