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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210587

Registered date:28/01/2022

An Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedAdvanced Malignancies
Date of first enrollment07/02/2022
Target sample size10
Countries of recruitmentU.S.A,Japan,Denmark,Japan,Italy,Japan
Study typeInterventional
Intervention(s)Patients enrolled and treated in a clinical study (parent study) of Pemigatinib as monotherapy or combination therapy will continue to receive one of the study treatment 1-3. Study Treatment 1: Pemigatinib (INCB054828) will be taken orally once daily Study Treatment 2: Pemigatininb+ Retifanlimab Participants rolling over from study INCB 54828-101 only will receive Pemigatinib (INCB054828) once daily and Retifanlimab will be administered once every 4 weeks. 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.

Outcome(s)

Primary OutcomeNumber of Treatment Emergent Adverse Events (TEAEs)
Secondary OutcomeNone

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 90age old
GenderBoth
Include 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.
Exclude 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.

Related Information

Contact

Public contact
Name Medical Information Center
Address Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan Tokyo Japan 100-0006
Telephone +81-120-094-139
E-mail jpmedinfo@incyte.com
Affiliation Incyte Biosciences Japan G.K.
Scientific contact
Name Ueda Eiji
Address Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan Tokyo Japan 100-0006
Telephone +81-120-094-139
E-mail jpmedinfo@incyte.com
Affiliation Incyte Biosciences Japan G.K.