Trial Outcomes & Findings for Zalutumumab in Combination With Radiotherapy in Head and Neck Cancer Patients Ineligible for Platinum Based Chemotherapy (NCT NCT00707655)
NCT ID: NCT00707655
Last Updated: 2023-08-03
Results Overview
Number of participants with at least one adverse event. All adverse events are collected during 12 weeks and all serious adverse events are collected during 2 years.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
From first dose date up to end of the safety follow up period (Up to 2 years)
Results posted on
2023-08-03
Participant Flow
Participant milestones
| Measure |
Zalutumumab 4 mg/kg
8 weekly infusions
|
Zalutumumab 8 mg/kg
8 weekly infusions
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zalutumumab in Combination With Radiotherapy in Head and Neck Cancer Patients Ineligible for Platinum Based Chemotherapy
Baseline characteristics by cohort
| Measure |
Zalutumumab 4 mg/kg
n=3 Participants
8 weekly infusions
|
Zalutumumab 8 mg/kg
n=5 Participants
8 weekly infusions
|
Total
n=8 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
73 years
n=5 Participants
|
70 years
n=7 Participants
|
72 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose date up to end of the safety follow up period (Up to 2 years)Population: Analysis set included all 8 participants who were enrolled in the study.
Number of participants with at least one adverse event. All adverse events are collected during 12 weeks and all serious adverse events are collected during 2 years.
Outcome measures
| Measure |
Zalutumumab 4 mg/kg
n=3 Participants
|
Zalutumumab 8 mg/kg
n=5 Participants
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Analysis set included all 8 participants who were enrolled in the study. Overall number of participants analyzed are the participants who are available for the assessment.
The Best Overall Tumour Response 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
| Measure |
Zalutumumab 4 mg/kg
n=3 Participants
|
Zalutumumab 8 mg/kg
n=4 Participants
|
|---|---|---|
|
Number of Participants With Best Overall Tumour Response
Complete response
|
3 Participants
|
1 Participants
|
|
Number of Participants With Best Overall Tumour Response
Partial response
|
0 Participants
|
3 Participants
|
|
Number of Participants With Best Overall Tumour Response
Stable disease
|
0 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Tumour Response
Progressive disease
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Analysis set included all 8 participants who were enrolled in the study.
Objective response is defined as CR or PR according to RECIST criteria. CR is defined as the disappearance of all target lesions. PR is 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.
Outcome measures
| Measure |
Zalutumumab 4 mg/kg
n=3 Participants
|
Zalutumumab 8 mg/kg
n=5 Participants
|
|---|---|---|
|
Number of Participants With Objective Response
|
3 Participants
|
4 Participants
|
Adverse Events
Zalutumumab 4 mg/kg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Zalutumumab 8 mg/kg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zalutumumab 4 mg/kg
n=3 participants at risk
8 weekly infusions
|
Zalutumumab 8 mg/kg
n=5 participants at risk
8 weekly infusions
|
|---|---|---|
|
Gastrointestinal disorders
Oral mucositis
|
66.7%
2/3 • Number of events 2 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
0.00%
0/5 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
General disorders
Infusion related reaction
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Investigations
Loss of weight
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
General disorders
Mucositis
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
General disorders
Disease progression
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Psychiatric disorders
Febrile multifactorial confusion
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
Other adverse events
| Measure |
Zalutumumab 4 mg/kg
n=3 participants at risk
8 weekly infusions
|
Zalutumumab 8 mg/kg
n=5 participants at risk
8 weekly infusions
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Gastrointestinal disorders
Constipation
|
100.0%
3/3 • Number of events 3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Gastrointestinal disorders
Dry mouth
|
100.0%
3/3 • Number of events 3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
80.0%
4/5 • Number of events 4 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
40.0%
2/5 • Number of events 3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Gastrointestinal disorders
Stomatitis
|
66.7%
2/3 • Number of events 2 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
0.00%
0/5 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Number of events 2 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
0.00%
0/5 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
General disorders
Disease progression
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
General disorders
Infusion related reaction
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
General disorders
Mucosal hemorrhage
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
General disorders
Pain
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Infections and infestations
Eye infection
|
33.3%
1/3 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Infections and infestations
Oral candidiasis
|
33.3%
1/3 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Infections and infestations
Skin infection
|
66.7%
2/3 • Number of events 2 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
0.00%
0/5 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
66.7%
2/3 • Number of events 2 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Investigations
Blood magnesium
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Investigations
Blood magnesium decreased
|
33.3%
1/3 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
0.00%
0/5 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Investigations
Blood potassium decreased
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Investigations
Cardiac murmur
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Investigations
Haemoglobin decreased
|
33.3%
1/3 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
0.00%
0/5 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
0.00%
0/5 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Investigations
Weight decreased
|
66.7%
2/3 • Number of events 2 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
0.00%
0/5 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
66.7%
2/3 • Number of events 3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
0.00%
0/5 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Metabolism and nutrition disorders
Hypophagia
|
33.3%
1/3 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
0.00%
0/5 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
0.00%
0/5 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Number of events 2 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
40.0%
2/5 • Number of events 2 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
40.0%
2/5 • Number of events 2 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
33.3%
1/3 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
40.0%
2/5 • Number of events 3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
0.00%
0/5 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
20.0%
1/5 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Rash
|
100.0%
3/3 • Number of events 3 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
100.0%
5/5 • Number of events 7 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
33.3%
1/3 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
0.00%
0/5 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
|
General disorders
Mucosal Inflammation
|
33.3%
1/3 • Number of events 1 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
100.0%
5/5 • Number of events 7 • From first dose date up to end of the safety follow up period (Up to 2 years)
|
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