Trial Outcomes & Findings for Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208) (NCT NCT04003623)
NCT ID: NCT04003623
Last Updated: 2022-05-10
Results Overview
Defined as the proportion of participants in each cohort who achieve a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
TERMINATED
PHASE2
1 participants
Up to approximately 6 months
2022-05-10
Participant Flow
Approximately 50 participants were planned for enrollment. However, only 1 participant was enrolled in the study (assigned to Cohort A) and data was analyzed for safety. The study was closed for lack of enrollment in 2021.
A total of 1 participant (assigned to Cohort A) was enrolled in the study, received at least 1 dose of pemigatinib, and was included in the safety population. The participant withdrew consent after Cycle 2+. As a result, there was no efficacy evaluable population.
Participant milestones
| Measure |
Cohort A: Participants With FGFR1-3 In-frame Fusions or FGFR2 Intron 17 Rearrangements
Participants will receive 13.5mg QD Pemigatinib
|
Cohort B: Participants With Known/Predicted Activating Point Mutations in FGFGR1-3
Participants will receive 13.5mg QD Pemigatinib
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort A: Participants With FGFR1-3 In-frame Fusions or FGFR2 Intron 17 Rearrangements
Participants will receive 13.5mg QD Pemigatinib
|
Cohort B: Participants With Known/Predicted Activating Point Mutations in FGFGR1-3
Participants will receive 13.5mg QD Pemigatinib
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)
Baseline characteristics by cohort
| Measure |
Cohort A: Participants With FGFR1-3 In-frame Fusions or FGFR2 Intron 17 Rearrangements
n=1 Participants
Participants will receive 13.5mg QD Pemigatinib
|
Cohort B: Participants With Known/Predicted Activating Point Mutations in FGFGR1-3
Participants will receive 13.5mg QD Pemigatinib
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
NA Participants
n=99 Participants
|
—
|
NA Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
NA Participants
n=99 Participants
|
—
|
NA Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
NA Participants
n=99 Participants
|
—
|
NA Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
NA Participants
n=99 Participants
|
—
|
NA Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
NA Participants
n=99 Participants
|
—
|
NA Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
NA Participants
n=99 Participants
|
—
|
NA Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
NA Participants
n=99 Participants
|
—
|
NA Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
NA Participants
n=99 Participants
|
—
|
NA Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
NA Participants
n=99 Participants
|
—
|
NA Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 6 monthsPopulation: Due to low participant enrollment (n=1), efficacy analyses were not conducted.
Defined as the proportion of participants in each cohort who achieve a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 6 monthsPopulation: Due to low participant enrollment (n=1), efficacy analyses were not conducted.
Defined as the time from first dose until progressive disease (per RECIST v1.1 or Response Assessment in Neuro-Oncology \[RANO\]) or death (whichever is first) in each cohort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 6 monthsPopulation: Due to low participant enrollment (n=1), efficacy analyses were not conducted.
Defined as the time from the date of first assessment of CR or PR until the date of the first progressive disease (per RECIST v1.1 or RANO) or death (whichever is first) in each cohort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 6 monthsPopulation: Due to low participant enrollment (n=1), efficacy analyses were not conducted.
Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease per RECIST v1.1 or RANO.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 6 monthsPopulation: Due to low participant enrollment (n=1), efficacy analyses were not conducted.
Defined as the time from first dose of study drug to death of any cause in each cohort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 6 monthsPopulation: Due to low participant enrollment (n=1), efficacy analyses were not conducted.
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A: Participants With FGFR1-3 In-frame Fusions or FGFR2 Intron 17 Rearrangements
Cohort B: Participants With Known/Predicted Activating Point Mutations in FGFGR1-3
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A: Participants With FGFR1-3 In-frame Fusions or FGFR2 Intron 17 Rearrangements
n=1 participants at risk
Participants will receive 13.5mg QD Pemigatinib
|
Cohort B: Participants With Known/Predicted Activating Point Mutations in FGFGR1-3
Participants will receive 13.5mg QD Pemigatinib
|
|---|---|---|
|
Eye disorders
Blurred Vision
|
100.0%
1/1 • Number of events 1 • May 2020 to June 2020
Treatment-emergent adverse events, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).
|
—
0/0 • May 2020 to June 2020
Treatment-emergent adverse events, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Number of events 1 • May 2020 to June 2020
Treatment-emergent adverse events, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).
|
—
0/0 • May 2020 to June 2020
Treatment-emergent adverse events, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • May 2020 to June 2020
Treatment-emergent adverse events, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).
|
—
0/0 • May 2020 to June 2020
Treatment-emergent adverse events, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
100.0%
1/1 • Number of events 2 • May 2020 to June 2020
Treatment-emergent adverse events, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).
|
—
0/0 • May 2020 to June 2020
Treatment-emergent adverse events, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).
|
|
Musculoskeletal and connective tissue disorders
Lower Back Pain
|
100.0%
1/1 • Number of events 1 • May 2020 to June 2020
Treatment-emergent adverse events, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).
|
—
0/0 • May 2020 to June 2020
Treatment-emergent adverse events, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
1/1 • Number of events 1 • May 2020 to June 2020
Treatment-emergent adverse events, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).
|
—
0/0 • May 2020 to June 2020
Treatment-emergent adverse events, defined as adverse events that were either reported for the first time or the worsening of pre-existing events after the first dose of study drug until 30 days after the last dose of study drug, are reported for members of the Safety Population (all randomized participants who received at least one dose of study treatment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER