Clinical trial NCT04949191: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced Malignancies
Keywords: pemigatinib
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2021-07-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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.

Primary outcomes:
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: up to at least 30 days after the last dose of study treatment or until toxicities resolve, return to baseline, or are deemed irreversible, whichever was longer (up to 1010 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute
state: California
city: Charlotte
country: United States
facility: Oncology Specialists of Charlotte
state: North Carolina
city: Houston
country: United States
facility: Md Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, Pc
state: Virginia
city: Copenhagen
country: Denmark
facility: The Finsen Centre National Hospital
city: Milan
country: Italy
facility: Fondazione Irccs Istituto Nazionale Dei Tumori
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena Irccs
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte
city: Yokohama-Shi
country: Japan
facility: Kanagawa Cancer Center
Study officials:
affiliation: Incyte Corporation
name: Peter Langmuir
role: STUDY_DIRECTOR
References: