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

Advanced or Metastatic Solid Tumors Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04003623
• Other study ID #: INCB 54828-MA-TA-208
• Status: Terminated
• Phase: Phase 2
• Start date: October 31, 2019
• Est. completion date: June 12, 2020

Study information

• Verified date: April 2022
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 12, 2020
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumors
• FGFR Mutations
• FGFR Translocations
• Neoplasms

Intervention

Drug:
• Pemigatinib
Pemigatinib administered orally once daily.

Locations

Country	Name	City	State
United States	New Jersey Cancer Care and Blood Disorders	Belleville	New Jersey
United States	TriHealth	Cincinnati	Ohio
United States	Mary Crowley Cancer Center	Dallas	Texas
United States	Compassionate Cancer Care Medical Group	Fountain Valley	California
United States	FMH James M Stockman Cancer Institute	Frederick	Maryland
United States	Hawaii Cancer Care	Honolulu	Hawaii
United States	Oncology Consultants	Houston	Texas
United States	Ocala Oncology Center	Ocala	Florida
United States	Illinois Cancer Care	Peoria	Illinois
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	Sanford Cancer Center	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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