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

• Sponsor: Genmab (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00677924
• Collaborator: (none)
• Enrollment: 9
• Locations: 3
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 3
• Patients Per Site Per Month: 0.3

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: Zalutumumab	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Apr 1, 2008
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zalutumumab 8 mg/kg Zalutumumab in combination with Irinotecan	Drug: Zalutumumab; Solution for infusion; Other Names: HuMax-EGFr
Experimental: Zalutumumab 16 mg/kg Zalutumumab in combination with Irinotecan	Drug: Zalutumumab; Solution for infusion; Other Names: HuMax-EGFr

Outcome Measures

Primary Outcome Measures

1. Adverse Events [Overall Study]

   Number of patients experiencing an adverse event

Secondary Outcome Measures

1. Best Overall Response [Overall Study]

   Best overall response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Jules Bordet	Brussels		Belgium	1000
2	Hospital Erasme	Brussels		Belgium	1070
3	St-Luc University Hospital	Brussels		Belgium	1200

Sponsors and Collaborators

• Genmab

Investigators

• Study Director: Hassan Aladdin, ICTM, Genmab

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genmab
• ClinicalTrials.gov Identifier: NCT00677924
• Other Study ID Numbers: GEN206
• First Posted: May 15, 2008
• Last Update Posted: Dec 23, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Genmab: Colorectal Neoplasms; Colorectal Tumors; Colorectal Carcinoma
• Additional relevant MeSH terms: Colorectal Neoplasms; Zalutumumab

Study Results

Participant Flow

Arm/Group Title	Zalatumumab 8 mg/kg	Zalutumumab 16 mg/kg
Arm/Group Description
Period Title: Overall Study
STARTED	3	6
COMPLETED	3	6
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Zalatumumab 8 mg/kg	Zalutumumab 16 mg/kg	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	3	6	9
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 66.7%	5 83.3%	7 77.8%
>=65 years	1 33.3%	1 16.7%	2 22.2%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	61	61	61
Sex: Female, Male (Count of Participants)
Female	1 33.3%	5 83.3%	6 66.7%
Male	2 66.7%	1 16.7%	3 33.3%
Region of Enrollment (participants) [Number]
Belgium	3 100%	6 100%	9 100%

Outcome Measures

1. Primary Outcome

Title	Adverse Events
Description	Number of patients experiencing an adverse event
Time Frame	Overall Study

Outcome Measure Data

Analysis Population Description

Number of patients experiencing an adverse event

Arm/Group Title	Zalatumumab 8 mg/kg	Zalutumumab 16 mg/kg
Arm/Group Description
Measure Participants	3	6
Number [participants]	3 100%	6 100%

2. Secondary Outcome

Title	Best Overall Response
Description	Best overall response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16
Time Frame	Overall Study

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Zalatumumab 8 mg/kg	Zalutumumab 16 mg/kg
Arm/Group Description
Measure Participants	3	6
Complete Response	0 0%	0 0%
Partial Response	0 0%	0 0%
Stable Disease	3 100%	4 66.7%
Progressive Disease	0 0%	2 33.3%
Not Evaluable	0 0%	0 0%

Adverse Events

Time Frame	Adverse events were collected during 10 months
Arm/Group Title	Zalatumumab 8 mg/kg		Zalutumumab 16 mg/kg
Arm/Group Description
All Cause Mortality
	Zalatumumab 8 mg/kg		Zalutumumab 16 mg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Zalatumumab 8 mg/kg		Zalutumumab 16 mg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/3 (66.7%)		3/6 (50%)
Gastrointestinal disorders
Colonic obstruction	0/3 (0%)	0	1/6 (16.7%)	1
General disorders
Disease progression	1/3 (33.3%)	1	1/6 (16.7%)	1
Hepatobiliary disorders
Bile duct obstruction	0/3 (0%)	0	1/6 (16.7%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	2/3 (66.7%)	2	0/6 (0%)	0
Other (Not Including Serious) Adverse Events
	Zalatumumab 8 mg/kg		Zalutumumab 16 mg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		5/6 (83.3%)
Blood and lymphatic system disorders
Neutropenia	0/3 (0%)	0	2/6 (33.3%)	3
Gastrointestinal disorders
Nausea	3/3 (100%)	4	4/6 (66.7%)	4
Diarrhoea	3/3 (100%)	5	3/6 (50%)	6
Vomiting	2/3 (66.7%)	3	1/6 (16.7%)	1
Abdominal pain	0/3 (0%)	0	2/6 (33.3%)	2
General disorders
Fatigue	3/3 (100%)	3	4/6 (66.7%)	4
Disease progression	1/3 (33.3%)	1	1/6 (16.7%)	1
Headache	1/3 (33.3%)	1	1/6 (16.7%)	1
Myalgia	0/3 (0%)	0	2/6 (33.3%)	2
Metabolism and nutrition disorders
Anorexia	2/3 (66.7%)	2	2/6 (33.3%)	2
Renal and urinary disorders
Urinary tract infection	1/3 (33.3%)	1	1/6 (16.7%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/3 (0%)	0	3/6 (50%)	3
Pulmonary embolism	2/3 (66.7%)	2	0/6 (0%)	0
Skin and subcutaneous tissue disorders
Dry skin	2/3 (66.7%)	2	5/6 (83.3%)	5
Rash	2/3 (66.7%)	2	4/6 (66.7%)	4

Limitations/Caveats

The trial was prematurely closed when 9 out of 97 patients were enrolled. The trial design was originally divided in two parts. Patient allocation was terminated before Part 2 was started.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The site and the PI may be required to withhold the publication for up to 90 days. Subject to a reasoned request from the sponsor, the publication may be further delayed for a period up to 6 months from the date of first submission to the sponsor. The sponsor has the right to require deletion of any trade secret, proprietary, or confidential information supplied by the sponsor to the site or the PI. The sponsor shall not otherwise have the right to censor publications.