Zalutumumab With or Without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-04-30

Brief Summary

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The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in combination with Irinotecan for the treatment of patients with Colorectal Cancer

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Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zalutumumab 8 mg/kg

Zalutumumab in combination with Irinotecan

Group Type EXPERIMENTAL

Zalutumumab

Intervention Type DRUG

Solution for infusion

Zalutumumab 16 mg/kg

Zalutumumab in combination with Irinotecan

Group Type EXPERIMENTAL

Zalutumumab

Intervention Type DRUG

Solution for infusion

Interventions

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Zalutumumab

Solution for infusion

Intervention Type DRUG

Other Intervention Names

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HuMax-EGFr

Eligibility Criteria

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Inclusion Criteria

1. Males and Females age ≥ 18 years
2. Confirmed diagnosis of CRC
3. Documented disease progression
4. Failure and/or intolerance to standard chemotherapy

Exclusion Criteria

1. Prior treatment with anti-EGFR antibodies other than cetuximab
2. Expected survival \< 3 months
3. Clinical significant cardiac disease and/or uncontrolled medical conditions

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No