A Phase I/II Study of Cediranib (AZD2171) in Japanese Metastatic Colorectal Cancer Patients in Combination With FOLFOX

February 26, 2014 updated by: AstraZeneca

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

This Study is in two parts, the first part is to make sure that combining a potential new treatment, cediranib (AZD2171), with a standard treatment (FOLFOX) for metastatic colorectal cancer is safe. Once this part is complete and it is decided that it is safe to continue the Study will the go on to look at the efficacy of the two drugs together. This will be done by studying two treatment options. One will be the standard treatment alone (FOLFOX) + dummy cediranib (AZD2171) tablets and the other will be the standard treatment (FOLFOX) + real cediranib (AZD2171) tablets. Using dummy tablets means the study is 'blinded' and that non-one can tell the difference between the two treatment groups. This kind of study design is done to try to avoid the chance that the results might be biased in some way. The overall aim of the second part of the study is to see if adding cediranib (AZD2171) to a standard treatment for Metastatic Colorectal Cancer (mCRC), in this case FOLFOX, gives better results. That is, it's better than giving standard treatment alone in helping to prevent progression of mCRC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan
        • Research Site
      • Saitama, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: FOLFOX + Cediranib 20 mg
Drug: AZD2171
oral tablet
Other Names:
  • RECENTIN™
  • cediranib
Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Other Names:
  • 5-FU
  • Leucovorin
  • Eloxatin®
ACTIVE_COMPARATOR: FOLFOX + Cediranib 30 mg
Drug: AZD2171
oral tablet
Other Names:
  • RECENTIN™
  • cediranib
Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Other Names:
  • 5-FU
  • Leucovorin
  • Eloxatin®
PLACEBO_COMPARATOR: FOLFOX + Placebo Cediranib
Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
intravenous infusion
Other Names:
  • 5-FU
  • Leucovorin
  • Eloxatin®
Drug: Placebo Cediranib
oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
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)
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.
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Tumour Response Rate
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)
Number of patients with complete (CR) /partial response (PR) (based on RECIST). CR is defined as Disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of Longest Diameter (LD) of target lesions taking as reference the baseline sum LD.
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)
Best Percentage Change in Tumour Size
Time Frame: Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)
Best percentage change in tumour size from baseline, based on the sum of the longest diameters of the target lesions
Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)
Duration of Response
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)
Number of months from Complete/Partial response until progression up to cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups).
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)
Overall Survival
Time Frame: Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)
Number of months until death (censored if still alive at date cut-off). Median non-estimable if >50% of subjects within a group are censored.
Randomisation until cut-off date 13OCT2009 (based on approximately 105 progression events observed across the 3 groups)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Hideyuki Mishima, M.D., PhD, National Hospital Organization Osaka National Hospital
  • Study Chair: Xiaojin Shi, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

June 27, 2007

First Submitted That Met QC Criteria

June 27, 2007

First Posted (ESTIMATE)

June 29, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 27, 2014

Last Update Submitted That Met QC Criteria

February 26, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8480C00039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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