Description:
Safety and tolerability of pemigatinib.in monotherapy or combination in patients that have participated in a previous parent study to treat advanced malignancies.
Clinical Trials /
The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies.
NCT04949191
Related Conditions:
- Malignant Solid Tumor
Recruiting Status:
Recruiting
Phase:
Phase 2
Trial Eligibility
Document
Title
- Brief Title: The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies.
- Official Title: An Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib
Clinical Trial IDs
- ORG STUDY ID: INCB 54828-801
- NCT ID: NCT04949191
Conditions
- Advanced Malignancies
Interventions
| Drug | Synonyms | Arms |
|---|---|---|
| Pemigatinib | INCB054828 | Study Treatment 1: Pemigatinib (INCB054828) |
| Retifanlimab | INCMGA0012 | Study Treatment 2: Pemigatininb+ Retifanlimab |
| Pembrolizumab | Study Treatment 3: Pemigatininb + Pembrolizumab |
Purpose
Safety and tolerability of pemigatinib.in monotherapy or combination in patients that have
participated in a previous parent study to treat advanced malignancies.
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
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| Study Treatment 1: Pemigatinib (INCB054828) | Experimental | Pemigatinib will be taken orally once daily |
|
| Study Treatment 2: Pemigatininb+ Retifanlimab | Experimental | Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and retifanlimab will be administered once every 4 weeks |
|
| Study Treatment 3: Pemigatininb + Pembrolizumab | Experimental | Participants rolling over from study INCB 54828-101 only will receive pemigatinib once daily and pembroluzimab as per dosage instructions. |
|
Eligibility Criteria
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.
| Maximum Eligible Age: | 90 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of Treatment Emergent Adverse Events (TEAEs) |
| Time Frame: | up to 30 days after last dose |
| Safety Issue: | |
| Description: | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Incyte Corporation |
Trial Keywords
- pemigatinib
Last Updated
August 4, 2021
