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A Two Part Study in Japanese Patients With mCRC, Consisting of an Open-label Phase I Part to Assess the Safety and Tolerability of Cediranib (AZD2171) in Combination With FOLFOX Followed by a Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of Cediranib (AZD2171) in Combination With FOLFOX


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

A Two Part Study in Japanese Patients With mCRC, Consisting of an Open-label Phase I Part to Assess the Safety and Tolerability of Cediranib (AZD2171) in Combination With FOLFOX Followed by a Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of Cediranib (AZD2171) in Combination With FOLFOX


Inclusion Criteria:



- Metastatic colorectal cancer

- WHO performance status 0-1

- Life expectancy is 12 weeks or longer

Exclusion Criteria:

- Patient with uncontrolled brain metastases

- Patient with inappropriate laboratory tests values

- Patient with poorly controlled hypertension

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.

Outcome Time Frame:

RECIST at Baseline, Weeks 6, 12, 18, 24 and then every 12 weeks until progression through to a cut-off date of 13th Oct 2009 (based on approx 105 progression events observed across the 3 groups)

Safety Issue:

No

Principal Investigator

Jane Robertson

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

D8480C00039

NCT ID:

NCT00494221

Start Date:

June 2007

Completion Date:

December 2012

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal cancer
  • Recentin
  • Metastatic Cancer
  • FOLFOX
  • Colorectal Neoplasms

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