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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00677924
Other study ID # GEN206
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date April 2008
Est. completion date April 2009

Study information

Verified date July 2023
Source Genmab
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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