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

NCT04003623 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: INCB 54828-MA-TA-208
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 11

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.

Conditions

Advanced or Metastatic Solid Tumors; FGFR Mutations; FGFR Translocations

Keywords

Advanced solid tumor; metastatic solid tumor; FGFR inhibitor; FGFR mutation; FGFR translocation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Progression-free Survival (PFS)

  Up to approximately 6 months

• Duration of Response (DOR)

  Up to approximately 6 months

• Disease Control Rate (DCR)

  Up to approximately 6 months

• Overall Survival (OS)

  Up to approximately 6 months

• Number of Treatment-related Adverse Events

  Up to approximately 6 months

Study Arms (1)

Pemigatinib

EXPERIMENTAL

Drug: Pemigatinib

Interventions

Pemigatinib DRUG

Pemigatinib administered orally once daily.

Also known as: INCB054828

Pemigatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (11)

Compassionate Cancer Care Medical Group

Fountain Valley, California, 92708, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Hawaii Cancer Care

Honolulu, Hawaii, 96813, United States

Location

Illinois Cancer Care

Peoria, Illinois, 61615, United States

Location

FMH James M Stockman Cancer Institute

Frederick, Maryland, 21702, United States

Location

New Jersey Cancer Care and Blood Disorders

Belleville, New Jersey, 07109, United States

Location

TriHealth

Cincinnati, Ohio, 45220, United States

Location

Sanford Cancer Center

Sioux Falls, South Dakota, 51704, United States

Location

Mary Crowley Cancer Center

Dallas, Texas, 75230, United States

Location

Oncology Consultants

Houston, Texas, 77030, United States

Location

Utah Cancer Specialists

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

pemigatinib

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The Sponsor made a decision unrelated to safety to halt study enrollment. Due to early termination of the study with only1 participant, no analysis of efficacy endpoints was done.

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 1, 2019
• Study Start: October 31, 2019
• Primary Completion: June 12, 2020
• Study Completion: June 12, 2020
• Last Updated: May 10, 2022
• Results First Posted: April 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.

Locations

US (11)