Trial Outcomes & Findings for A Phase II Study of Dacomitinib in Progressive Brain Metastases (NCT NCT02047747)
NCT ID: NCT02047747
Last Updated: 2016-09-22
Results Overview
Intra-cranial objective response rate at 2 months as assessed by the Response Assessment in Neuro-oncology (RANO) criteria
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
2 months
Results posted on
2016-09-22
Participant Flow
Participant milestones
| Measure |
Dacomitinib
Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.
Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase II Study of Dacomitinib in Progressive Brain Metastases
Baseline characteristics by cohort
| Measure |
Dacomitinib
n=4 Participants
Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.
Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data not available.
Intra-cranial objective response rate at 2 months as assessed by the Response Assessment in Neuro-oncology (RANO) criteria
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of Treatment (4-6 weeks after permanent discontinuation of study treatment for any reason)Population: The study was terminated due to slow enrollment. Please see adverse event section for additional information.
Outcome measures
Outcome data not reported
Adverse Events
Dacomitinib
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dacomitinib
n=4 participants at risk
Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.
Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.
|
|---|---|
|
Eye disorders
diplopia
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
diarrhea
|
50.0%
2/4 • Number of events 2
|
|
Gastrointestinal disorders
nausea/vomitting
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
dry mouth
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
heartburn
|
25.0%
1/4 • Number of events 1
|
|
General disorders
fatigue
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
anemia
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
elevated ALT
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
elevated AST
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
sinusitis
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
cough
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
thrush
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
hypokalemia
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
hyponatremia
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
jaw trismus
|
25.0%
1/4 • Number of events 1
|
|
Renal and urinary disorders
increased creatinine
|
25.0%
1/4 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
rash
|
25.0%
1/4 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
dry skin/cracking (fingertips/nail bed)
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
acne
|
25.0%
1/4 • Number of events 1
|
Additional Information
David Piccioni M.D., Ph.D.
University of California, San Diego
Phone: (858) 822-6346
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place