Trial Outcomes & Findings for Zalutumumab With or Without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer (NCT NCT00677924)

Last Updated: 2023-07-18

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

9 participants

Primary outcome timeframe

From first dose up to follow-up (up to approximately 1 year)

Results posted on

2023-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	Zalatumumab 8 mg/kg Participants received zalutumumab 8 milligrams per kilogram (mg/kg) intravenously once weekly in combination with irinotecan 180 milligrams per meter square (mg/m\^2) every 2 weeks up to 10 months.	Zalutumumab 16 mg/kg Participants received zalutumumab 16 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m\^2 every 2 weeks up to 10 months.
Overall Study STARTED	3	6
Overall Study COMPLETED	3	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zalatumumab 8 mg/kg n=3 Participants Participants received zalutumumab 8 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m\^2 every 2 weeks up to 10 months.	Zalutumumab 16 mg/kg n=6 Participants Participants received zalutumumab 16 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m\^2 every 2 weeks up to 10 months.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	61 years n=5 Participants	61 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Belgium	3 participants n=5 Participants	6 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose up to follow-up (up to approximately 1 year)

Population: All participants who had been exposed to zalutumumab or irinotecan, irrespective of their compliance to the planned course of treatment.

Outcome measures

Outcome measures
Measure	Zalatumumab 8 mg/kg n=3 Participants Participants received zalutumumab 8 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m\^2 every 2 weeks up to 10 months.	Zalutumumab 16 mg/kg n=6 Participants Participants received zalutumumab 16 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m\^2 every 2 weeks up to 10 months.
Number of Participants With Adverse Events (AEs)	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: All participants who had been exposed to zalutumumab or irinotecan, irrespective of their compliance to the planned course of treatment.

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.

Outcome measures

Outcome measures
Measure	Zalatumumab 8 mg/kg n=3 Participants Participants received zalutumumab 8 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m\^2 every 2 weeks up to 10 months.	Zalutumumab 16 mg/kg n=6 Participants Participants received zalutumumab 16 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m\^2 every 2 weeks up to 10 months.
Number of Participants With Best Overall Tumour Response (BOR) Complete Response	0 Participants	0 Participants
Number of Participants With Best Overall Tumour Response (BOR) Partial Response	0 Participants	0 Participants
Number of Participants With Best Overall Tumour Response (BOR) Stable Disease	3 Participants	4 Participants
Number of Participants With Best Overall Tumour Response (BOR) Progressive Disease	0 Participants	2 Participants

Adverse Events

Zalatumumab 8 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Zalutumumab 16 mg/kg

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Zalatumumab 8 mg/kg n=3 participants at risk Participants received zalutumumab 8 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m\^2 every 2 weeks up to 10 months.	Zalutumumab 16 mg/kg n=6 participants at risk Participants received zalutumumab 16 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m\^2 every 2 weeks up to 10 months.
General disorders Disease progression	33.3% 1/3 • Number of events 1 • From first dose up to follow-up (up to approximately 1 year)	16.7% 1/6 • Number of events 1 • From first dose up to follow-up (up to approximately 1 year)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	66.7% 2/3 • Number of events 2 • From first dose up to follow-up (up to approximately 1 year)	0.00% 0/6 • From first dose up to follow-up (up to approximately 1 year)
Gastrointestinal disorders Colonic obstruction	0.00% 0/3 • From first dose up to follow-up (up to approximately 1 year)	16.7% 1/6 • Number of events 1 • From first dose up to follow-up (up to approximately 1 year)
Hepatobiliary disorders Bile duct obstruction	0.00% 0/3 • From first dose up to follow-up (up to approximately 1 year)	16.7% 1/6 • Number of events 1 • From first dose up to follow-up (up to approximately 1 year)

Other adverse events

Additional Information

Eva Järlid Westerberg, VP Clinical Operations

Genmab A/S

Phone: +45 7020 2728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Zalatumumab 8 mg/kg n=3 participants at risk Participants received zalutumumab 8 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m\^2 every 2 weeks up to 10 months.	Zalutumumab 16 mg/kg n=6 participants at risk Participants received zalutumumab 16 mg/kg intravenously once weekly in combination with irinotecan 180 mg/m\^2 every 2 weeks up to 10 months.
Gastrointestinal disorders Nausea	100.0% 3/3 • Number of events 4 • From first dose up to follow-up (up to approximately 1 year)	66.7% 4/6 • Number of events 4 • From first dose up to follow-up (up to approximately 1 year)
Skin and subcutaneous tissue disorders Dry skin	66.7% 2/3 • Number of events 2 • From first dose up to follow-up (up to approximately 1 year)	83.3% 5/6 • Number of events 5 • From first dose up to follow-up (up to approximately 1 year)
General disorders Fatigue	100.0% 3/3 • Number of events 3 • From first dose up to follow-up (up to approximately 1 year)	66.7% 4/6 • Number of events 4 • From first dose up to follow-up (up to approximately 1 year)
Gastrointestinal disorders Diarrhoea	100.0% 3/3 • Number of events 5 • From first dose up to follow-up (up to approximately 1 year)	50.0% 3/6 • Number of events 6 • From first dose up to follow-up (up to approximately 1 year)
Skin and subcutaneous tissue disorders Rash	66.7% 2/3 • Number of events 2 • From first dose up to follow-up (up to approximately 1 year)	66.7% 4/6 • Number of events 4 • From first dose up to follow-up (up to approximately 1 year)
Metabolism and nutrition disorders Anorexia	66.7% 2/3 • Number of events 2 • From first dose up to follow-up (up to approximately 1 year)	33.3% 2/6 • Number of events 2 • From first dose up to follow-up (up to approximately 1 year)
Gastrointestinal disorders Vomiting	66.7% 2/3 • Number of events 3 • From first dose up to follow-up (up to approximately 1 year)	16.7% 1/6 • Number of events 1 • From first dose up to follow-up (up to approximately 1 year)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From first dose up to follow-up (up to approximately 1 year)	50.0% 3/6 • Number of events 3 • From first dose up to follow-up (up to approximately 1 year)
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From first dose up to follow-up (up to approximately 1 year)	33.3% 2/6 • Number of events 3 • From first dose up to follow-up (up to approximately 1 year)
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From first dose up to follow-up (up to approximately 1 year)	33.3% 2/6 • Number of events 2 • From first dose up to follow-up (up to approximately 1 year)
General disorders Disease progression	33.3% 1/3 • Number of events 1 • From first dose up to follow-up (up to approximately 1 year)	16.7% 1/6 • Number of events 1 • From first dose up to follow-up (up to approximately 1 year)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	66.7% 2/3 • Number of events 2 • From first dose up to follow-up (up to approximately 1 year)	0.00% 0/6 • From first dose up to follow-up (up to approximately 1 year)
Renal and urinary disorders Urinary tract infection	33.3% 1/3 • Number of events 1 • From first dose up to follow-up (up to approximately 1 year)	16.7% 1/6 • Number of events 1 • From first dose up to follow-up (up to approximately 1 year)
General disorders Headache	33.3% 1/3 • Number of events 1 • From first dose up to follow-up (up to approximately 1 year)	16.7% 1/6 • Number of events 1 • From first dose up to follow-up (up to approximately 1 year)
General disorders Myalgia	0.00% 0/3 • From first dose up to follow-up (up to approximately 1 year)	33.3% 2/6 • Number of events 2 • From first dose up to follow-up (up to approximately 1 year)