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

NCT ID: NCT00494221

Last Updated: 2014-03-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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FOLFOX + Cediranib 20 mg

FOLFOX + Cediranib 20 mg

Group Type ACTIVE_COMPARATOR

AZD2171

Intervention Type DRUG

oral tablet

FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

Intervention Type DRUG

intravenous infusion

FOLFOX + Cediranib 30 mg

FOLFOX + Cediranib 30 mg

Group Type ACTIVE_COMPARATOR

AZD2171

Intervention Type DRUG

oral tablet

FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

Intervention Type DRUG

intravenous infusion

FOLFOX + Placebo Cediranib

FOLFOX + Placebo Cediranib

Group Type PLACEBO_COMPARATOR

FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

Intervention Type DRUG

intravenous infusion

Placebo Cediranib

Intervention Type DRUG

oral tablet

Interventions

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AZD2171

oral tablet

Intervention Type DRUG

FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)

intravenous infusion

Intervention Type DRUG

Placebo Cediranib

oral tablet

Intervention Type DRUG

Other Intervention Names

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RECENTIN™ Eloxatin® 5-FU Leucovorin cediranib

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jane Robertson

Role: STUDY_DIRECTOR

AstraZeneca

Hideyuki Mishima, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

National Hospital Organization Osaka National Hospital

Xiaojin Shi, MD

Role: STUDY_CHAIR

AstraZeneca

Locations

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Research Site

Osaka, , Japan

Site Status

Research Site

Saitama, , Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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D8480C00039

Identifier Type: -

Identifier Source: org_study_id

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