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

Advanced Malignancies Clinical Trial

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 Details — Status: Terminated

Administrative data

• NCT number: NCT04949191
• Other study ID #: INCB 54828-801
• Status: Terminated
• Phase: Phase 2
• Start date: July 8, 2021
• Est. completion date: April 11, 2024

Study information

• Verified date: May 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Safety and tolerability of pemigatinib.in monotherapy or combination in patients that have participated in a previous parent study to treat advanced malignancies.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 11, 2024
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Malignancies
• Neoplasms

Intervention

Drug:
• Pemigatinib
Pemigatinib tablets taken by mouth once daily as per protocol
• Retifanlimab
Retifanlimab is administered over 60 minutes once every 4 weeks (Day 1 of a 28-day cycle)
• Pembrolizumab
Commercially labeled products

Locations

Country	Name	City	State
Denmark	The Finsen Centre National Hospital	Copenhagen
Italy	Fondazione Irccs Istituto Nazionale Dei Tumori	Milan
Italy	Istituto Nazionale Tumori Regina Elena Irccs	Rome
Italy	Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte	Siena
Japan	Kanagawa Cancer Center	Yokohama-Shi
United States	Oncology Specialists of Charlotte	Charlotte	North Carolina
United States	Virginia Cancer Specialists, Pc	Fairfax	Virginia
United States	Md Anderson Cancer Center	Houston	Texas
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas
United States	John Wayne Cancer Institute	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Denmark,  Italy,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Treatment Emergent Adverse Events (TEAEs)	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.	up to 30 days after last dose