Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

• ClinicalTrials.gov Identifier: NCT03822117
• Recruitment Status: Recruiting
• First Posted: January 30, 2019
• Last Update Posted: October 30, 2020
• Sponsor: Incyte Corporation
• Information provided by (Responsible Party): Incyte Corporation

Tracking Information

• First Submitted Date: January 28, 2019
• First Posted Date: January 30, 2019
• Last Update Posted Date: October 30, 2020
• Actual Study Start Date: May 29, 2019
• Estimated Primary Completion Date: December 17, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 28, 2019)

• Objective response rate (ORR) in Cohort A [ Time Frame: Up to approximately 6 months ]
  Defined as the proportion of participants in Cohort A who achieve a complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (RANO) as determined by an independent radiological review committee.
• ORR in Cohort B [ Time Frame: Up to approximately 6 months ]
  Defined as the proportion of participants in Cohort B who achieve a CR or PR based on RECIST v1.1 or RANO as determined by an independent radiological review committee.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 28, 2019)

• Progression-free survival (PFS) [ Time Frame: Up to approximately 6 months ]
  Defined as the time from first dose until progressive disease (according to RECIST v1.1 or RANO and assessed by an independent central review) or death (whichever is first) in Cohorts A and B, respectively.
• Duration of response (DOR) [ Time Frame: Up to approximately 6 months ]
  Defined as the time from the date of first assessment of CR or PR until the date of the first progressive disease (according to RECIST v1.1 or RANO and assessed by an independent central review) or death (whichever is first) in Cohorts A and B, respectively.
• Overall survival (OS) [ Time Frame: Up to approximately 6 months ]
  Defined as the time from first dose of study drug to death of any cause in Cohorts A and B, respectively.
• Number of treatment-emergent adverse events [ Time Frame: Up to approximately 6 months ]
  Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
• Number of treatment-related adverse events. [ Time Frame: Up to approximately 6 months ]
  Adverse events considered to be treatment-related by the investigator.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
• 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 Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
• 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 tumor malignancies harboring activating FGFR mutations or translocations.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

This study consists of 3 cohorts that will have study drug administered in parallel, Cohort A, Cohort B, and Cohort C. There is no difference in the treatment regimen between the cohorts.

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Solid Tumor Malignancy

Intervention

Drug: Pemigatinib

Pemigatinib administered orally once daily (QD).

Other Name: INCB054828

Study Arms

Experimental: Pemigatinib

Cohort A (Solid tumor malignancies with FGFR1-3 in frame fusions). Cohort B (Solid tumor malignancies with activating point mutations in FGFR1-3) Cohort C (Solid tumor malignancies with any other FGFR1-3 point mutations and variants of unknown significance).

Intervention: Drug: Pemigatinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 28, 2019): 170
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 17, 2022
• Estimated Primary Completion Date: December 17, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic or is surgically unresectable.
• Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors). Tumor lesions located in a previously irradiated area or in an area subjected to other loco-regional therapy are considered measureable if progression has been clearly demonstrated in the lesion.
• Documentation of an FGFR1-3 gene mutation or translocation.
• Objective progression after at least 1 prior therapy and no therapy available that is likely to provide clinical benefit. Participants who are intolerant to or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit.
• Eastern Cooperative Oncology Group performance status 0 to 2.
• Baseline archival tumor specimen (if < 12 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or approximately 15 unstained slides from biopsy or resection of primary tumor or metastasis.
• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

• Prior receipt of a selective FGFR inhibitor in the past 6 months.
• Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of pemigatinib.
• Cannot be a candidate for potentially curative surgery.
• Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
• Radiation therapy administered within 2 weeks of enrollment/first dose of study treatment.
• Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
• Known additional malignancy that is progressing or requires active treatment.
• History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
• Clinically significant or uncontrolled cardiac disease.
• Active chronic or current infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment within 2 weeks before enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed).
• Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as elevated transaminases or cirrhosis; chronic HBV/HCV infection with no cirrhosis and no elevated transaminases is allowed).
• Known HIV infection.
• Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or five half-lives (whichever is longer) before the first dose of study drug/treatment.
• Women who are pregnant or breastfeeding.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Incyte Corporation Call Center(U.S); 1.855.463.3463; medinfo@incyte.com

Contact: Incyte Corporation Call Center (ex-US); +800 00027423; globalmedinfo@incyte.com

• Listed Location Countries: Denmark, France, Germany, Israel, Italy, Japan, Korea, Republic of, Spain, Switzerland, United Kingdom, United States

Administrative Information

• NCT Number: NCT03822117
• Other Study ID Numbers: INCB 54828-207
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

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

• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (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.
• URL: https://www.incyte.com/our-company/compliance-and-transparency

• Responsible Party: Incyte Corporation
• Study Sponsor: Incyte Corporation
• Collaborators: Not Provided

Investigators

• Study Director: Luis Féliz, MD; Incyte Corporation

• PRS Account: Incyte Corporation
• Verification Date: October 2020