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 |
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Health condition(s) or Problem(s) studied | Advanced Malignancies |
Date of first enrollment | 07/02/2022 |
Target sample size | 10 |
Countries of recruitment | U.S.A,Japan,Denmark,Japan,Italy,Japan |
Study type | Interventional |
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 Outcome | Number of Treatment Emergent Adverse Events (TEAEs) |
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Secondary Outcome | None |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | <= 90age old |
Gender | Both |
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
Primary Sponsor | Eiji Ueda |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT04949191 |
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 |
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 |
jpmedinfo@incyte.com | |
Affiliation | Incyte Biosciences Japan G.K. |