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The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies.

Sponsor
Incyte Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04949191
Collaborator
(none)
10
Enrollment
10
Locations
3
Arms
21.6
Anticipated Duration (Months)
1
Patient Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib
Actual Study Start Date :
Jul 12, 2021
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Treatment 1: Pemigatinib (INCB054828)

Pemigatinib will be taken orally once daily

Drug: Pemigatinib
Pemigatinib tablets taken by mouth once daily as per protocol
Other Names:
  • INCB054828

    		•
    Experimental: 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

    Drug: Pemigatinib
    Pemigatinib tablets taken by mouth once daily as per protocol
    Other Names:
  • INCB054828

    • Drug: Retifanlimab
    Retifanlimab is administered over 60 minutes once every 4 weeks (Day 1 of a 28-day cycle)
    Other Names:
  • INCMGA0012

    		•
    Experimental: 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.

    Drug: Pemigatinib
    Pemigatinib tablets taken by mouth once daily as per protocol
    Other Names:
  • INCB054828

    • Drug: Pembrolizumab
    Commercially labeled products

    Outcome Measures

    Primary Outcome Measures

    1. Number of Treatment Emergent Adverse Events (TEAEs) [up to 30 days after last dose]

      Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts 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/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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 John Wayne Cancer Institute Santa Monica California United States 90404
    2 Oncology Specialists of Charlotte Charlotte North Carolina United States 28207
    3 Md Anderson Cancer Center Houston Texas United States 77030
    4 South Texas Accelerated Research Therapeutics San Antonio Texas United States 78229
    5 Virginia Cancer Specialists, Pc Fairfax Virginia United States 22031
    6 The Finsen Centre National Hospital Copenhagen Denmark 02100
    7 Fondazione Irccs Istituto Nazionale Dei Tumori Milan Italy 20133
    8 Istituto Nazionale Tumori Regina Elena Irccs Rome Italy 00144
    9 Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte Siena Italy 53100
    10 Kanagawa Cancer Center Yokohama-Shi Japan 241-8515

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Peter Langmuir, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT04949191
    Other Study ID Numbers:
    • INCB 54828-801
    First Posted:
    Jul 2, 2021
    Last Update Posted:
    Jun 28, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Corporation
    pemigatinib
    Additional relevant MeSH terms:
    Neoplasms
    Pembrolizumab

    Study Results

    No Results Posted as of Jun 28, 2022