Trial Outcomes & Findings for Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer (NCT NCT00460551)
NCT ID: NCT00460551
Last Updated: 2011-12-06
Results Overview
Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Until disease progression
Results posted on
2011-12-06
Participant Flow
Participant milestones
| Measure |
Zalutumumab 8 mg/kg
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer
Baseline characteristics by cohort
| Measure |
Zalutumumab 8 mg/kg
n=13 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=93 Participants
|
|
Age Continuous
|
66 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
|
Region of Enrollment
France
|
2 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=93 Participants
|
|
Region of Enrollment
Belgium
|
6 participants
n=93 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Until disease progressionPopulation: Data was not collected. Imaging scans were not taken during part 1A. The trial was prematurely closed when 13 patients were enrolled in part 1A. Scans were planned for part 1B and 2. No patients continued to part 1B and part 2.
Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: Number of patients reporting at least one adverse event
Number of participants reporting at least one adverse event
Outcome measures
| Measure |
Zalatumumab 8 mg/kg
n=13 Participants
|
|---|---|
|
Adverse Events
|
13 participants
|
Adverse Events
Zalutumumab 8 mg/kg
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zalutumumab 8 mg/kg
n=13 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
23.1%
3/13 • Number of events 3 • Up to 3 months
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Number of events 1 • Up to 3 months
|
|
Gastrointestinal disorders
Ileus
|
7.7%
1/13 • Number of events 1 • Up to 3 months
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
1/13 • Number of events 1 • Up to 3 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
15.4%
2/13 • Number of events 2 • Up to 3 months
|
|
General disorders
Chills
|
7.7%
1/13 • Number of events 1 • Up to 3 months
|
|
General disorders
Malaise
|
7.7%
1/13 • Number of events 1 • Up to 3 months
|
|
Infections and infestations
Gastroenteritis
|
7.7%
1/13 • Number of events 1 • Up to 3 months
|
|
Infections and infestations
Viral infection
|
7.7%
1/13 • Number of events 1 • Up to 3 months
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Number of events 1 • Up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.7%
1/13 • Number of events 1 • Up to 3 months
|
Other adverse events
| Measure |
Zalutumumab 8 mg/kg
n=13 participants at risk
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
100.0%
13/13 • Number of events 241 • Up to 3 months
|
|
Gastrointestinal disorders
Constipation
|
76.9%
10/13 • Number of events 22 • Up to 3 months
|
|
Gastrointestinal disorders
Diarrhoea
|
61.5%
8/13 • Number of events 14 • Up to 3 months
|
|
Gastrointestinal disorders
Nausea
|
61.5%
8/13 • Number of events 14 • Up to 3 months
|
|
General disorders
Fatigue
|
61.5%
8/13 • Number of events 14 • Up to 3 months
|
|
Gastrointestinal disorders
Dyspepsia
|
38.5%
5/13 • Number of events 7 • Up to 3 months
|
|
Gastrointestinal disorders
Dysphagia
|
38.5%
5/13 • Number of events 6 • Up to 3 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
38.5%
5/13 • Number of events 7 • Up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.5%
5/13 • Number of events 8 • Up to 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
38.5%
5/13 • Number of events 6 • Up to 3 months
|
|
Metabolism and nutrition disorders
Anorexia
|
38.5%
5/13 • Number of events 7 • Up to 3 months
|
Additional Information
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