Trial Outcomes & Findings for Zalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer (NCT NCT00401401)
NCT ID: NCT00401401
Last Updated: 2011-12-23
Results Overview
Number of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Overall Study
Results posted on
2011-12-23
Participant Flow
Participant milestones
| Measure |
Zalutumumab 4 mg/kg
Zalutumumab 8 weekly infusions
|
Zalutumumab 8 mg/kg
Zalutumumab 8 weeky infusions
|
Zalutumumab 12 mg/kg
Zalutumumab 8 weekly infusions
|
Zalutumumab 16 mg/kg
Zalutumumab 8 weekly infusions
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
12
|
|
Overall Study
COMPLETED
|
6
|
6
|
5
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Zalutumumab 4 mg/kg
n=6 Participants
Zalutumumab 8 weekly infusions
|
Zalutumumab 8 mg/kg
n=6 Participants
Zalutumumab 8 weeky infusions
|
Zalutumumab 12 mg/kg
n=6 Participants
Zalutumumab 8 weekly infusions
|
Zalutumumab 16 mg/kg
n=12 Participants
Zalutumumab 8 weekly infusions
|
Total
n=30 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age Continuous
|
58 years
n=5 Participants
|
54 years
n=7 Participants
|
49 years
n=5 Participants
|
52 years
n=4 Participants
|
52 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
17 participants
n=21 Participants
|
|
Region of Enrollment
Sweden
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
8 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Overall StudyNumber of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial.
Outcome measures
| Measure |
Zalutumumab 4 mg/kg
n=6 Participants
|
Zalutumumab 8 mg/kg
n=6 Participants
|
Zalutumumab 12 mg/kg
n=6 Participants
|
Zalutumumab 16 mg/kg
n=12 Participants
|
|---|---|---|---|---|
|
Adverse Events
|
6 participants
|
6 participants
|
6 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsTumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. 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
Outcome measures
| Measure |
Zalutumumab 4 mg/kg
n=6 Participants
|
Zalutumumab 8 mg/kg
n=6 Participants
|
Zalutumumab 12 mg/kg
n=6 Participants
|
Zalutumumab 16 mg/kg
n=12 Participants
|
|---|---|---|---|---|
|
Overall Response
|
6 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Number of months between date of first infusion and date of best response
Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. 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
Outcome measures
| Measure |
Zalutumumab 4 mg/kg
n=6 Participants
|
Zalutumumab 8 mg/kg
n=4 Participants
|
Zalutumumab 12 mg/kg
n=2 Participants
|
Zalutumumab 16 mg/kg
n=5 Participants
|
|---|---|---|---|---|
|
Time to Response
|
5.79 months
Interval 3.8 to 12.0
|
3.98 months
Interval 3.9 to 6.4
|
4.31 months
Interval 4.2 to 4.5
|
5.80 months
Interval 4.0 to 6.4
|
SECONDARY outcome
Timeframe: Up to 3 yearsTumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. 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
Outcome measures
| Measure |
Zalutumumab 4 mg/kg
n=6 Participants
|
Zalutumumab 8 mg/kg
n=6 Participants
|
Zalutumumab 12 mg/kg
n=6 Participants
|
Zalutumumab 16 mg/kg
n=12 Participants
|
|---|---|---|---|---|
|
Best Overall Tumor Response
Progressive disease
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Best Overall Tumor Response
Complete response
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
|
Best Overall Tumor Response
Partial response
|
5 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Best Overall Tumor Response
Stable disease
|
0 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
|
Best Overall Tumor Response
Nonevaluable
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Zalutumumab 4 mg/kg
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Zalutumumab 8 mg/kg
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Zalutumumab 12 mg/kg
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Zalutumumab 16 mg/kg
Serious events: 11 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zalutumumab 4 mg/kg
n=6 participants at risk
Zalutumumab 8 weekly infusions
|
Zalutumumab 8 mg/kg
n=6 participants at risk
Zalutumumab 8 weeky infusions
|
Zalutumumab 12 mg/kg
n=6 participants at risk
Zalutumumab 8 weekly infusions
|
Zalutumumab 16 mg/kg
n=12 participants at risk
Zalutumumab 8 weekly infusions
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
16.7%
2/12 • Number of events 2
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
25.0%
3/12 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Death
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
|
General disorders
Disease progression
|
0.00%
0/6
|
0.00%
0/6
|
50.0%
3/6 • Number of events 3
|
16.7%
2/12 • Number of events 2
|
|
General disorders
General physical health deterioration
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Infusion related reaction
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Pyrexia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Herpes dermatitis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Infection in immunocompromised host
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Meningitis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
25.0%
3/12 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer recurrent
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer stage II
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal neoplasm
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
|
Vascular disorders
Iliac artery occlusion
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
Other adverse events
| Measure |
Zalutumumab 4 mg/kg
n=6 participants at risk
Zalutumumab 8 weekly infusions
|
Zalutumumab 8 mg/kg
n=6 participants at risk
Zalutumumab 8 weeky infusions
|
Zalutumumab 12 mg/kg
n=6 participants at risk
Zalutumumab 8 weekly infusions
|
Zalutumumab 16 mg/kg
n=12 participants at risk
Zalutumumab 8 weekly infusions
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
100.0%
3/3 • Number of events 3
|
33.3%
2/6 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
25.0%
3/12 • Number of events 3
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
16.7%
2/12 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
16.7%
2/12 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Number of events 3
|
66.7%
4/6 • Number of events 4
|
33.3%
2/6 • Number of events 2
|
33.3%
4/12 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
100.0%
6/6 • Number of events 6
|
100.0%
6/6 • Number of events 8
|
83.3%
5/6 • Number of events 6
|
66.7%
8/12 • Number of events 8
|
|
Gastrointestinal disorders
Dysphagia
|
83.3%
5/6 • Number of events 5
|
83.3%
5/6 • Number of events 6
|
83.3%
5/6 • Number of events 6
|
75.0%
9/12 • Number of events 9
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Number of events 9
|
83.3%
5/6 • Number of events 7
|
50.0%
3/6 • Number of events 5
|
50.0%
6/12 • Number of events 9
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
4/6 • Number of events 5
|
50.0%
3/6 • Number of events 5
|
50.0%
3/6 • Number of events 3
|
50.0%
6/12 • Number of events 8
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Disease progression
|
0.00%
0/6
|
0.00%
0/6
|
50.0%
3/6 • Number of events 3
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Fatigue
|
83.3%
5/6 • Number of events 6
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
41.7%
5/12 • Number of events 5
|
|
General disorders
Mucosal inflammation
|
100.0%
6/6 • Number of events 6
|
100.0%
6/6 • Number of events 7
|
83.3%
5/6 • Number of events 5
|
75.0%
9/12 • Number of events 9
|
|
General disorders
Pyrexia
|
50.0%
3/6 • Number of events 4
|
33.3%
2/6 • Number of events 5
|
16.7%
1/6 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
|
Infections and infestations
Laryngitis
|
83.3%
5/6 • Number of events 5
|
100.0%
6/6 • Number of events 7
|
83.3%
5/6 • Number of events 6
|
75.0%
9/12 • Number of events 12
|
|
Infections and infestations
Pharyngitis
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
2/12 • Number of events 2
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
66.7%
4/6 • Number of events 5
|
83.3%
10/12 • Number of events 13
|
|
Investigations
Weight decreased
|
66.7%
4/6 • Number of events 4
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
41.7%
5/12 • Number of events 5
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
|
Nervous system disorders
Dysgeusia
|
50.0%
3/6 • Number of events 4
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
41.7%
5/12 • Number of events 5
|
|
Psychiatric disorders
Anxiety
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
66.7%
4/6 • Number of events 4
|
66.7%
4/6 • Number of events 5
|
16.7%
1/6 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6
|
66.7%
4/6 • Number of events 6
|
33.3%
2/6 • Number of events 3
|
41.7%
5/12 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
66.7%
4/6 • Number of events 4
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
16.7%
2/12 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
3/6 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
50.0%
3/6 • Number of events 3
|
50.0%
6/12 • Number of events 7
|
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