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

JRCT ID: jRCT2031210587

Registered date:28/01/2022

Basic Information

• Recruitment status: Not Recruiting
• 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)
• Secondary Outcome: None

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• 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
• Secondary ID(s): NCT04949191