Clinical trial NCT04003623: Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)
Official title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumors Harboring Activating FGFR Mutations or Translocations (FIGHT-208)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced or Metastatic Solid Tumors
FGFR Mutations
FGFR Translocations
Keywords: Advanced solid tumor
metastatic solid tumor
FGFR inhibitor
FGFR mutation
FGFR translocation
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2019-07-01
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be assigned to 1 of 2 cohorts (Cohort A: FGFR1-3 in-frame fusions or FGFR2 intron 17 rearrangements; Cohort B: Known/predicted activating point mutations in FGFR1-3 \[excluding kinase domain\]) but there is no difference in the treatment regimen between the cohorts.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumors harboring activating FGFR mutations or translocations.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic (Stage IIIB or IV) or is surgically unresectable.
* Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors).
* Documentation of an FGFR1-3 gene mutation or translocation.
* Objective disease progression after at least 1 prior therapy.
* Not eligible or able to participate in any other Incyte-sponsored clinical trial.

Exclusion Criteria:

* Advanced/metastatic bladder cancer or advanced/metastatic cholangiocarcinoma.
* Prior receipt of a selective FGFR inhibitor.
* Current evidence of clinically significant corneal or retinal disorder.
* History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 6 months
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 6 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 6 months
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 6 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 6 months
measure: Number of Treatment-related Adverse Events
timeFrame: Up to approximately 6 months
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care Medical Group
state: California
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Honolulu
country: United States
facility: Hawaii Cancer Care
state: Hawaii
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Frederick
country: United States
facility: FMH James M Stockman Cancer Institute
state: Maryland
city: Belleville
country: United States
facility: New Jersey Cancer Care and Blood Disorders
state: New Jersey
city: Cincinnati
country: United States
facility: TriHealth
state: Ohio
city: Sioux Falls
country: United States
facility: Sanford Cancer Center
state: South Dakota
city: Dallas
country: United States
facility: Mary Crowley Cancer Center
state: Texas
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: