Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)

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)

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.

Study Overview

• Status: Terminated
• Conditions: Advanced or Metastatic Solid Tumors; FGFR Mutations; FGFR Translocations
• Intervention / Treatment: Drug: Pemigatinib

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Compassionate Cancer Care Medical Group
  • Florida
    • Ocala, Florida, United States, 34474
      • Ocala Oncology Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Hawaii Cancer Care
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
  • Maryland
    • Frederick, Maryland, United States, 21702
      • FMH James M Stockman Cancer Institute
  • New Jersey
    • Belleville, New Jersey, United States, 07109
      • New Jersey Cancer Care and Blood Disorders
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • TriHealth
  • South Dakota
    • Sioux Falls, South Dakota, United States, 51704
      • Sanford Cancer Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Mary Crowley Cancer Center
    • Houston, Texas, United States, 77030
      • Oncology Consultants
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pemigatinib	Drug: Pemigatinib; Pemigatinib administered orally once daily.; Other Names: INCB054828

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Defined as the proportion of participants in each cohort who achieve a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	Up to approximately 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	Defined as the time from first dose until progressive disease (per RECIST v1.1 or Response Assessment in Neuro-Oncology [RANO]) or death (whichever is first) in each cohort.	Up to approximately 6 months
Duration of Response (DOR)	Defined as the time from the date of first assessment of CR or PR until the date of the first progressive disease (per RECIST v1.1 or RANO) or death (whichever is first) in each cohort.	Up to approximately 6 months
Disease Control Rate (DCR)	Defined as the proportion of participants who achieved best overall response of CR, PR, or stable disease per RECIST v1.1 or RANO.	Up to approximately 6 months
Overall Survival (OS)	Defined as the time from first dose of study drug to death of any cause in each cohort.	Up to approximately 6 months
Number of Treatment-related Adverse Events	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.	Up to approximately 6 months

Collaborators and Investigators

• Sponsor: Incyte Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 31, 2019
• Primary Completion (ACTUAL): June 12, 2020
• Study Completion (ACTUAL): June 12, 2020

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (ACTUAL): July 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: metastatic solid tumor; Advanced solid tumor; FGFR inhibitor; FGFR mutation; FGFR translocation
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: INCB 54828-MA-TA-208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No