Trial Outcomes & Findings for Zalutumumab in Non-curable Patients With SCCHN (NCT NCT00542308)
NCT ID: NCT00542308
Last Updated: 2023-08-03
Results Overview
OS was defined as time from start of treatment until date of death of any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
From randomization until death, assessed up to 21 months
Results posted on
2023-08-03
Participant Flow
All participants attending Visit 2 were included in the FAS irrespective of their compliance with the planned course of zalutumumab.
Participant milestones
| Measure |
Zalutumumab 4-16 mg/kg
Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
|
|---|---|
|
Overall Study
STARTED
|
90
|
|
Overall Study
COMPLETED
|
90
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zalutumumab in Non-curable Patients With SCCHN
Baseline characteristics by cohort
| Measure |
Zalutumumab 4-16 mg/kg
n=90 Participants
Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=99 Participants
|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 8.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=99 Participants
|
|
Region of Enrollment
Portugal
|
10 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=99 Participants
|
|
Region of Enrollment
Czech Republic
|
6 participants
n=99 Participants
|
|
Region of Enrollment
Slovakia
|
4 participants
n=99 Participants
|
|
Region of Enrollment
Peru
|
4 participants
n=99 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=99 Participants
|
|
Region of Enrollment
Israel
|
12 participants
n=99 Participants
|
|
Region of Enrollment
Chile
|
8 participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
11 participants
n=99 Participants
|
|
Region of Enrollment
Colombia
|
1 participants
n=99 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From randomization until death, assessed up to 21 monthsPopulation: All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.
OS was defined as time from start of treatment until date of death of any cause.
Outcome measures
| Measure |
Zalutumumab 4-16 mg/kg
n=90 Participants
Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
|
|---|---|
|
Overall Survival (OS)
|
5.3 months
Interval 4.1 to 7.1
|
SECONDARY outcome
Timeframe: During treatment and two weeks after end of treatment, assessed up to 21 months.Population: All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab. Overall number of participants analyzed are number of participants with data available for analysis of best response.
Objective Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0). Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR. Stable disease is Responses not fulfilling CR, PR or progressive disease (PD). PD is At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions.
Outcome measures
| Measure |
Zalutumumab 4-16 mg/kg
n=88 Participants
Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
|
|---|---|
|
Objective Tumour Response
Complete response
|
1 participants
|
|
Objective Tumour Response
Partial response
|
4 participants
|
|
Objective Tumour Response
Stable response
|
30 participants
|
|
Objective Tumour Response
Progressive disease
|
33 participants
|
|
Objective Tumour Response
Not evaluable
|
20 participants
|
SECONDARY outcome
Timeframe: During treatment and two weeks after end of treatment, assessed up to 21 monthsPopulation: All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab. Overall number of participants analyzed are the number of participants with a response.
DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier.
Outcome measures
| Measure |
Zalutumumab 4-16 mg/kg
n=5 Participants
Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
|
|---|---|
|
Duration of Response
|
NA days
Median and 95% confidence interval were not estimable due to insufficient number of participants with response.
|
SECONDARY outcome
Timeframe: During treatment and two weeks after end of treatment, assessed up to 21 monthsPopulation: All participants attending Visit 2 were included in the full analysis set irrespective of their compliance with the planned course of zalutumumab.
PFS is defined as the time from start of treatment until disease progression or death.
Outcome measures
| Measure |
Zalutumumab 4-16 mg/kg
n=90 Participants
Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
|
|---|---|
|
Progression Free Survival (PFS)
|
8.6 months
Interval 8.0 to 10.4
|
Adverse Events
Zalutumumab 4-16 mg/kg
Serious events: 83 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zalutumumab 4-16 mg/kg
n=90 participants at risk
Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
3.3%
3/90 • Number of events 3 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Cardiac disorders
CARDIAC ARREST
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Gastrointestinal disorders
DYSPHAGIA
|
5.6%
5/90 • Number of events 6 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Gastrointestinal disorders
OESOPHAGEAL FISTULA
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Gastrointestinal disorders
VOMITING
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
General disorders
DISEASE PROGRESSION
|
61.1%
55/90 • Number of events 55 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
2.2%
2/90 • Number of events 3 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
General disorders
INFUSION RELATED REACTION
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
General disorders
OEDEMA
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
General disorders
PAIN
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
General disorders
PERFORMANCE STATUS DECREASED
|
2.2%
2/90 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
General disorders
SUDDEN DEATH
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Infections and infestations
ABSCESS
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Infections and infestations
CATHETER RELATED INFECTION
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Infections and infestations
EYE INFECTION
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Infections and infestations
LUNG INFECTION
|
2.2%
2/90 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Infections and infestations
PNEUMONIA
|
7.8%
7/90 • Number of events 8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Infections and infestations
SEPSIS
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Infections and infestations
SKIN INFECTION
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Infections and infestations
UROSEPSIS
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Infections and infestations
WOUND INFECTION
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Injury, poisoning and procedural complications
FALL
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Investigations
WEIGHT DECREASED
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
4.4%
4/90 • Number of events 4 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
4.4%
4/90 • Number of events 4 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LUNG
|
2.2%
2/90 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM PROGRESSION
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR HAEMORRHAGE
|
6.7%
6/90 • Number of events 6 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Nervous system disorders
FACIAL PARESIS
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Nervous system disorders
QUADRIPARESIS
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Renal and urinary disorders
RENAL TUBULAR DISORDER
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
10.0%
9/90 • Number of events 9 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Respiratory, thoracic and mediastinal disorders
HYDROPNEUMOTHORAX
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
2.2%
2/90 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
3.3%
3/90 • Number of events 3 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
2.2%
2/90 • Number of events 2 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ACIDOSIS
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Skin and subcutaneous tissue disorders
RASH
|
1.1%
1/90 • Number of events 1 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
Other adverse events
| Measure |
Zalutumumab 4-16 mg/kg
n=90 participants at risk
Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
11.1%
10/90 • Number of events 10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Eye disorders
CONJUNCTIVITIS
|
6.7%
6/90 • Number of events 7 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Gastrointestinal disorders
CONSTIPATION
|
11.1%
10/90 • Number of events 10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Gastrointestinal disorders
DIARRHOEA
|
13.3%
12/90 • Number of events 15 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Gastrointestinal disorders
NAUSEA
|
17.8%
16/90 • Number of events 22 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Gastrointestinal disorders
VOMITING
|
16.7%
15/90 • Number of events 20 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
General disorders
ASTHENIA
|
18.9%
17/90 • Number of events 23 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
General disorders
FATIGUE
|
21.1%
19/90 • Number of events 26 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
General disorders
MUCOSAL INFLAMMATION
|
10.0%
9/90 • Number of events 12 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
General disorders
OEDEMA PERIPHERAL
|
5.6%
5/90 • Number of events 5 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
General disorders
PAIN
|
12.2%
11/90 • Number of events 14 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
General disorders
PYREXIA
|
20.0%
18/90 • Number of events 31 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Infections and infestations
BRONCHITIS
|
7.8%
7/90 • Number of events 9 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Infections and infestations
FOLLICULITIS
|
6.7%
6/90 • Number of events 6 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Infections and infestations
PARONYCHIA
|
8.9%
8/90 • Number of events 8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
5.6%
5/90 • Number of events 7 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Investigations
HAEMOGLOBIN DECREASED
|
8.9%
8/90 • Number of events 8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Investigations
WEIGHT DECREASED
|
7.8%
7/90 • Number of events 8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Metabolism and nutrition disorders
ANOREXIA
|
7.8%
7/90 • Number of events 8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
6.7%
6/90 • Number of events 6 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
20.0%
18/90 • Number of events 26 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
7.8%
7/90 • Number of events 7 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
10.0%
9/90 • Number of events 10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR HAEMORRHAGE
|
5.6%
5/90 • Number of events 8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Nervous system disorders
DIZZINESS
|
5.6%
5/90 • Number of events 7 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Nervous system disorders
HEADACHE
|
17.8%
16/90 • Number of events 19 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Psychiatric disorders
INSOMNIA
|
11.1%
10/90 • Number of events 10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
7.8%
7/90 • Number of events 7 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
15.6%
14/90 • Number of events 16 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Respiratory, thoracic and mediastinal disorders
RHONCHI
|
5.6%
5/90 • Number of events 6 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
11.1%
10/90 • Number of events 10 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Skin and subcutaneous tissue disorders
RASH
|
75.6%
68/90 • Number of events 85 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Skin and subcutaneous tissue disorders
SKIN FISSURES
|
14.4%
13/90 • Number of events 14 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Vascular disorders
HYPERTENSION
|
5.6%
5/90 • Number of events 5 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
|
Vascular disorders
HYPOTENSION
|
8.9%
8/90 • Number of events 8 • From first dose until the end of the safety follow-up period (30 days after last dose) up to 93.58 weeks
|
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