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Zalutumumab With or Without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer (GEN206)

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Zalutumumab
Sponsored by
Genmab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring Colorectal Neoplasms, Colorectal Tumors, Colorectal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Jules Bordet
  • Hospital Erasme
  • St-Luc University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Zalutumumab 8 mg/kg

Zalutumumab 16 mg/kg

Arm Description

Zalutumumab in combination with Irinotecan

Zalutumumab in combination with Irinotecan

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 13, 2008
Last Updated
July 3, 2023
Sponsor
Genmab
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1. Study Identification

Unique Protocol Identification Number
NCT00677924
Brief Title
Zalutumumab With or Without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to changes in portfolio review
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genmab

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Neoplasms, Colorectal Tumors, Colorectal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zalutumumab 8 mg/kg
Arm Type
Experimental
Arm Description
Zalutumumab in combination with Irinotecan
Arm Title
Zalutumumab 16 mg/kg
Arm Type
Experimental
Arm Description
Zalutumumab in combination with Irinotecan
Intervention Type
Drug
Intervention Name(s)
Zalutumumab
Other Intervention Name(s)
HuMax-EGFr
Intervention Description
Solution for infusion
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
From first dose up to follow-up (up to approximately 1 year)
Secondary Outcome Measure Information:
Title
Number of Participants With Best Overall Tumour Response (BOR)
Description
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.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and Females age ≥ 18 years Confirmed diagnosis of CRC Documented disease progression Failure and/or intolerance to standard chemotherapy Exclusion Criteria: Prior treatment with anti-EGFR antibodies other than cetuximab Expected survival < 3 months Clinical significant cardiac disease and/or uncontrolled medical conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Aladdin, ICTM
Organizational Affiliation
Genmab
Official's Role
Study Director
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hospital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
St-Luc University Hospital
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
result

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

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