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

Colorectal Cancer Clinical Trial

— GEN206  

Official title:

A Dose-Escalation, Randomized Phase I/II Trial of Zalutumumab - a Human Monoclonal Anti-EGF Receptor Antibody - With or Without Irinotecan Chemotherapy in Cetuximab Refractory Colorectal Cancer Patients Who Have Failed Standard Chemotherapy and Progressed During or Within 3 Months of Stopping Cetuximab-Based Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00677924
• Other study ID #: GEN206
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: April 2008
• Est. completion date: April 2009

Study information

• Verified date: July 2023
• Source: Genmab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Zalutumumab
Solution for infusion

Locations

Country	Name	City	State
Belgium	Hospital Erasme	Brussels
Belgium	Institut Jules Bordet	Brussels
Belgium	St-Luc University Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Genmab

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Mano M, Hendlisz A, Machiels JP, Ehrnrooth E, Aladdin H, Van Laethem JL. Phase I trial of zalutumumab and irinotecan in metastatic colorectal cancer patients who have failed irinotecan and cetuximab based therapy. J Clin Oncol 27 2009 (suppl;abstr e15028)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs)	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.	From first dose up to follow-up (up to approximately 1 year)
Secondary	Number of Participants With Best Overall Tumour Response (BOR)	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.	Up to 1 year