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

Phase 1

Terminated

• Conditions: Colorectal Cancer
• Interventions: Drug: Zalutumumab

• Registration Number: NCT00677924
• Lead Sponsor: Genmab

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-13
• Study First Submitted QC: 2008-05-14
• Study First Posted: 2008-05-15
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2011-09-12
• Results First Submitted QC: 2011-11-21
• Results First Posted: 2011-12-23
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zalutumumab 16 mg/kg	Zalutumumab	Zalutumumab in combination with Irinotecan
Zalutumumab 8 mg/kg	Zalutumumab	Zalutumumab in combination with Irinotecan

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	From first dose up to follow-up (up to approximately 1 year)	An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Best Overall Tumour Response (BOR)	Up to 1 year	The BOR defined as the best response recorded from the start of treatment until disease progression or recurrence per RECIST criteria. Complete response (CR) defined as the disappearance of all target lesions. Partial response (PR) defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Progressive disease (PD) defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions since the prior scan. Stable disease (SD) defined as responses not fulfilling CR, PR or PD.

Trial Locations

Locations (3)

Hospital Erasme; 🇧🇪 Brussels, Belgium

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

St-Luc University Hospital; 🇧🇪 Brussels, Belgium