The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies.
NCT ID: NCT04949191
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2021-07-08
2024-04-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study Treatment 1: Pemigatinib (INCB054828)
Pemigatinib will be taken orally once daily
Pemigatinib
Pemigatinib tablets taken by mouth once daily as per protocol
Study Treatment 2: Pemigatininb+ Retifanlimab
Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and retifanlimab will be administered once every 4 weeks
Pemigatinib
Pemigatinib tablets taken by mouth once daily as per protocol
Retifanlimab
Retifanlimab is administered over 60 minutes once every 4 weeks (Day 1 of a 28-day cycle)
Study Treatment 3: Pemigatininb + Pembrolizumab
Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and pembroluzimab as per dosage instructions.
Pemigatinib
Pemigatinib tablets taken by mouth once daily as per protocol
Pembrolizumab
Commercially labeled products
Interventions
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Pemigatinib
Pemigatinib tablets taken by mouth once daily as per protocol
Retifanlimab
Retifanlimab is administered over 60 minutes once every 4 weeks (Day 1 of a 28-day cycle)
Pembrolizumab
Commercially labeled products
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Permanently discontinued from the parent protocol for any reason.
* Women who are pregnant or breastfeeding or participants expecting to conceive or father children within the projected duration of the study.
18 Years
90 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Langmuir
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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John Wayne Cancer Institute
Santa Monica, California, United States
Oncology Specialists of Charlotte
Charlotte, North Carolina, United States
Md Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Virginia Cancer Specialists, Pc
Fairfax, Virginia, United States
The Finsen Centre National Hospital
Copenhagen, , Denmark
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, , Italy
Istituto Nazionale Tumori Regina Elena Irccs
Rome, , Italy
Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
Siena, , Italy
Kanagawa Cancer Center
Yokohama, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INCB 54828-801
Identifier Type: -
Identifier Source: org_study_id
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