The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies.
- Conditions
- Advanced Malignancies
- Interventions
- Registration Number
- NCT04949191
- Lead Sponsor
- Incyte Corporation
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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/exclusion criteria from the parent protocol if still receiving treatment.
- Women who are pregnant or breastfeeding or participants expecting to conceive or father children within the projected duration of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Treatment 1: Pemigatinib (INCB054828) Pemigatinib Pemigatinib will be taken orally once daily Study Treatment 2: Pemigatininb+ Retifanlimab Pemigatinib Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and retifanlimab will be administered once every 4 weeks Study Treatment 2: Pemigatininb+ Retifanlimab Retifanlimab Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and retifanlimab will be administered once every 4 weeks Study Treatment 3: Pemigatininb + Pembrolizumab Pemigatinib Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and pembroluzimab as per dosage instructions. Study Treatment 3: Pemigatininb + Pembrolizumab Pembrolizumab Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and pembroluzimab as per dosage instructions.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Virginia Cancer Specialists, Pc
🇺🇸Fairfax, Virginia, United States
Oncology Specialists of Charlotte
🇺🇸Charlotte, North Carolina, United States
Istituto Nazionale Tumori Regina Elena Irccs
🇮🇹Rome, Italy
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
🇮🇹Siena, Italy
Kanagawa Cancer Center
🇯🇵Yokohama-Shi, Japan
The Finsen Centre National Hospital
🇩🇰Copenhagen, Denmark
John Wayne Cancer Institute
🇺🇸Santa Monica, California, United States
Fondazione Irccs Istituto Nazionale Dei Tumori
🇮🇹Milan, Italy
Md Anderson Cancer Center
🇺🇸Houston, Texas, United States
South Texas Accelerated Research Therapeutics
🇺🇸San Antonio, Texas, United States