Trial Outcomes & Findings for BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer (NCT NCT02706691)
NCT ID: NCT02706691
Last Updated: 2019-04-16
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2019-04-16
Participant Flow
Participant milestones
| Measure |
BGJ398 (Infigratinib) Dosing
Patients receive BGJ398 (125 mg) by mouth once daily on a three weeks on, one week off schedule. Courses repeat every 28 days until disease progression or unacceptable toxicity.
BGJ398: Given by mouth (oral)
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
BGJ398 (Infigratinib) Dosing
Patients receive BGJ398 (125 mg) by mouth once daily on a three weeks on, one week off schedule. Courses repeat every 28 days until disease progression or unacceptable toxicity.
BGJ398: Given by mouth (oral)
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
BGJ398 (Infigratinib) Dosing
n=1 Participants
Patients receive BGJ398 (125 mg) by mouth once daily on a three weeks on, one week off schedule. Courses repeat every 28 days until disease progression or unacceptable toxicity.
BGJ398: Given by mouth (oral)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Study stopped after 1 patient enrolled. Endpoint could not be analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through 30 days after end of study treatmentPopulation: Study stopped after 1 patient enrolled. Endpoint could not be analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: BGJ398 (Infigratinib) Dosing
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: BGJ398 (Infigratinib) Dosing
Outcome measures
Outcome data not reported
Adverse Events
BGJ398 (Infigratinib) Dosing
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BGJ398 (Infigratinib) Dosing
n=1 participants at risk
Patients receive BGJ398 (125 mg) by mouth once daily on a three weeks on, one week off schedule. Courses repeat every 28 days until disease progression or unacceptable toxicity.
BGJ398: Given by mouth (oral)
|
|---|---|
|
Nervous system disorders
Stroke
|
100.0%
1/1 • Number of events 1 • Adverse events collected over entire treatment period (2 months)
|
Other adverse events
| Measure |
BGJ398 (Infigratinib) Dosing
n=1 participants at risk
Patients receive BGJ398 (125 mg) by mouth once daily on a three weeks on, one week off schedule. Courses repeat every 28 days until disease progression or unacceptable toxicity.
BGJ398: Given by mouth (oral)
|
|---|---|
|
Investigations
Elevated inorganic phosphaste
|
100.0%
1/1 • Number of events 1 • Adverse events collected over entire treatment period (2 months)
|
|
Injury, poisoning and procedural complications
Bruising
|
100.0%
1/1 • Number of events 1 • Adverse events collected over entire treatment period (2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • Number of events 1 • Adverse events collected over entire treatment period (2 months)
|
|
Gastrointestinal disorders
Dry mouth
|
100.0%
1/1 • Number of events 1 • Adverse events collected over entire treatment period (2 months)
|
|
Gastrointestinal disorders
Dysphagia
|
100.0%
1/1 • Number of events 1 • Adverse events collected over entire treatment period (2 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
100.0%
1/1 • Number of events 2 • Adverse events collected over entire treatment period (2 months)
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 2 • Adverse events collected over entire treatment period (2 months)
|
|
Gastrointestinal disorders
Tarry Stool
|
100.0%
1/1 • Number of events 1 • Adverse events collected over entire treatment period (2 months)
|
|
Gastrointestinal disorders
Lip Bleeding
|
100.0%
1/1 • Number of events 1 • Adverse events collected over entire treatment period (2 months)
|
|
General disorders
Bilateral ankle soreness
|
100.0%
1/1 • Number of events 1 • Adverse events collected over entire treatment period (2 months)
|
|
Gastrointestinal disorders
Mucositis oral
|
100.0%
1/1 • Number of events 1 • Adverse events collected over entire treatment period (2 months)
|
|
Skin and subcutaneous tissue disorders
Hand-foot Syndrome
|
100.0%
1/1 • Number of events 1 • Adverse events collected over entire treatment period (2 months)
|
|
Nervous system disorders
Tremor
|
100.0%
1/1 • Number of events 1 • Adverse events collected over entire treatment period (2 months)
|
Additional Information
Technical Director
University of Chicago Comprehensive Cancer Center
Phone: 773-702-0819
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place