Advanced Malignancies
Conditions
Keywords
pemigatinib
Brief summary
Safety and tolerability of pemigatinib.in monotherapy or combination in patients that have participated in a previous parent study to treat advanced malignancies.
Detailed description
A Phase 2 Open-Label, Multicenter, Rollover Study to evaluate the long term safety and tolerability of Pemigatinib and to provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib
Interventions
DRUGPemigatinib
Pemigatinib tablets taken by mouth once daily as per protocol
DRUGRetifanlimab
Retifanlimab is administered over 60 minutes once every 4 weeks (Day 1 of a 28-day cycle)
DRUGPembrolizumab
Commercially labeled products
Sponsors
Incyte Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Currently enrolled and receiving treatment in an Incyte-sponsored clinical study (parent protocol) of pemigatinib as monotherapy or combination therapy. * Currently benefiting from and tolerating treatment with pemigatinib, as determined by the investigator. * Demonstrated compliance, as assessed by the investigator, with the parent protocol requirements. * Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures. * Currently have no evidence of progressive disease, as determined by the investigator, following treatment with pemigatinib as monotherapy or combination therapy. * Willingness to avoid pregnancy or fathering children.
Exclusion criteria
* Able to access pemigatinib commercially or outside of a clinical trial. * Permanently discontinued from the parent protocol for any reason. * No longer meet the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to at least 30 days after the last dose of study treatment or until toxicities resolve, return to baseline, or are deemed irreversible, whichever was longer (up to 1010 days) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and until 30 days after the last dose of study drug. |
Countries
Denmark, Italy, Japan, United States
Participant flow
Recruitment details
Participants who were actively receiving treatment with pemigatinib (monotherapy or in combination with pembrolizumab) under a parent protocol, were receiving clinical benefit in those trials, and who did not have access to pemigatinib (as monotherapy or as combination therapy) outside of a clinical trial were enrolled.
Pre-assignment details
This study was conducted at 9 sites in 4 countries.
Participants by arm
| Arm | Count |
|---|---|
| Pemigatinib 6 mg and 13.5 mg Monotherapy Participants originally enrolled in a parent study (54828-201 \[NCT02872714\], 54828-202 \[NCT02924376\], or 54828-207 \[NCT03822117\]), who received clinical benefit from pemigatinib, and who did not have access to pemigatinib outside of a clinical trial self-administered oral pemigatinib 6 milligrams (mg) or 13.5 mg once daily (QD), either continuously in 21-day cycles or on a 2-weeks-on therapy/1-week-off therapy schedule in 21-day cycles. Pemigatinib was administered at the same dose received in the parent studies until documented disease progression or unacceptable toxicity. | 4 |
| Pemigatinib 9 mg Monotherapy Participants originally enrolled in a parent study (54828-201 \[NCT02872714\], 54828-202 \[NCT02924376\], or 54828-207 \[NCT03822117\]), who received clinical benefit from pemigatinib, and who did not have access to pemigatinib outside of a clinical trial self-administered oral pemigatinib 9 mg QD, either continuously in 21-day cycles or on a 2-weeks-on therapy/1-week-off therapy schedule in 21-day cycles. Pemigatinib was administered at the same dose received in the parent studies until documented disease progression or unacceptable toxicity. | 5 |
| Pemigatinib Combination Participants originally enrolled in parent study 54828-101 (NCT02393248), who received clinical benefit from the combination of pemigatinib plus pembrolizumab, and who did not have access to the combination outside of a clinical trial received received the combination of pemigatinib and pembrolizumab. Participants received pembrolizumab intravenously at 200 mg once every 3 weeks on Day 1 of each 21-day cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab. | 1 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Non-compliance with Study Drug | 1 | 0 | 0 | 0 |
| Overall Study | Progressive Disease | 0 | 1 | 0 | 0 |
| Overall Study | Sponsor Terminated Study | 0 | 0 | 1 | 1 |
| Overall Study | Transitioned to Commercial Pemigatinib | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Pemigatinib 6 mg and 13.5 mg Monotherapy | Pemigatinib 9 mg Monotherapy | Pemigatinib Combination | Total |
|---|---|---|---|---|
| Age, Continuous | 64.5 years STANDARD_DEVIATION 17.2 | 61.2 years STANDARD_DEVIATION 6.3 | NA years | NA years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | NA Participants | NA Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 5 Participants | NA Participants | NA Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | NA Participants | NA Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | NA Participants | NA Participants |
| Race/Ethnicity, Customized Black/African-American | 1 Participants | 0 Participants | NA Participants | NA Participants |
| Race/Ethnicity, Customized White/Caucasian | 2 Participants | 4 Participants | NA Participants | NA Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 5 | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 1 / 2 | 5 / 5 | 1 / 2 | 1 / 1 |
| serious Total, serious adverse events | 1 / 2 | 2 / 5 | 0 / 2 | 0 / 1 |
Outcome results
Primary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and until 30 days after the last dose of study drug.
Time frame: up to at least 30 days after the last dose of study treatment or until toxicities resolve, return to baseline, or are deemed irreversible, whichever was longer (up to 1010 days)
Population: Safety Population: all participants who received at least 1 dose of study treatment in this study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pemigatinib 6 mg Monotherapy | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 1 Participants |
| Pemigatinib 9 mg Monotherapy | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 5 Participants |
| Pemigatinib 13.5 mg Monotherapy | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 1 Participants |
| Pemigatinib Combination | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 1 Participants |