A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)

• ClinicalTrials.gov Identifier: NCT03011372
• Recruitment Status: Recruiting
• First Posted: January 5, 2017
• Last Update Posted: December 19, 2020
• Sponsor: Incyte Corporation
• Information provided by (Responsible Party): Incyte Corporation

Tracking Information

• First Submitted Date: January 4, 2017
• First Posted Date: January 5, 2017
• Last Update Posted Date: December 19, 2020
• Actual Study Start Date: April 25, 2017
• Estimated Primary Completion Date: July 31, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 30, 2019): The proportion of participants who achieve Complete Response (CR) based on response criteria for myeloid/lymphoid neoplasms with FGFR1 rearrangement [ Time Frame: : Assessed at protocol-defined timepoints through end of study, up to approximately 24 months. ]

Original Primary Outcome Measures (submitted: January 4, 2017)

Overall clinical benefit rate based on response criteria for myeloid/lymphoid neoplasms with FGFR1 rearrangement [ Time Frame: Assessed at protocol-defined timepoints through end of study, up to approximately 24 months. ]

Clinical benefit rate defined as the proportion of subjects who achieved a complete response (CR), partial response (PR), complete hematologic response (CHR), cytogenetic response, marrow response, or clinical benefit.

Current Secondary Outcome Measures (submitted: August 30, 2019)

• The proportion of subjects who achieve response, defined as a best response of CR or PR, as determined by investigator assessment according to the response criteria [ Time Frame: Assessed at protocol-defined timepoints through end of study, up to approximately 24 months. ]
• The proportion of subjects who achieve a complete cytogenetic response (CCyR) as assessed by local analysis and investigator evaluation [ Time Frame: Assessed at protocol-defined timepoints through end of study, up to approximately 24 months. ]
• The proportion of subjects who achieve a partial cytogenetic response (PCyR) as assessed by local analysis and investigator evaluation [ Time Frame: Assessed at protocol-defined timepoints through end of study, up to approximately 24 months. ]
• Duration of CR, defined as the time from first assessment of CR to the earlier of disease progression or death due to any cause [ Time Frame: Assessed at protocol-defined timepoints through end of study, up to approximately 24 months. ]
• Duration of response, defined as the time from first assessment of CR or PR to the earlier of disease progression or death due to any cause [ Time Frame: Assessed at protocol-defined timepoints through end of study, up to approximately 24 months. ]
• Progression-free survival (PFS) [ Time Frame: From the date of first study drug dose until the date of disease progression or until death due to any cause, whichever is earlier, assessed up to approximately 24 months. ]
  PFS is defined as the time from the first date of taking study drug until the date of disease progression, as measured by response criteria for myeloid/lymphoid neoplasms with FGFR1 rearrangement, or until death due to any cause, whichever is earlier.
• Overall survival [ Time Frame: From date of first study drug dose until death due to any cause, assessed up to approximately 24 months. ]
  Overall survival is defined as the time from the first day of taking study drug until death due to any cause. Subjects without death observed at the time of the analysis will be censored at last date known to be alive.
• Safety and tolerability as assessed by frequency, duration, and severity of adverse events [ Time Frame: From baseline through 30-35 days after end of treatment, up to 7 months per individual subject ]
  A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug. A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).

Original Secondary Outcome Measures (submitted: January 4, 2017)

• Duration of response/benefit [ Time Frame: Assessed at protocol-defined timepoints through end of study, up to approximately 24 months. ]
  Defined as the time from the date when the subject first achieves response/benefit until the date of the first documented disease progression.
• Progression-free survival [ Time Frame: From the date of first study drug dose until the date of disease progression or until death due to any cause, whichever is earlier, assessed up to approximately 24 months. ]
• Overall survival [ Time Frame: From date of first study drug dose until death due to any cause, assessed up to approximately 24 months. ]
• Safety and tolerability as assessed by frequency, duration, and severity of adverse events [ Time Frame: From baseline through 30-35 days after end of treatment, up to 7 months per individual subject ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)
• Official Title: A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)
• Brief Summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: MPN (Myeloproliferative Neoplasms)

Intervention

Drug: Pemigatinib

Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.

Participants will receive either the intermittent dose (as written) or continuous dosing.

Other Name: INCB054828

Study Arms

Experimental: Pemigatinib

Intervention: Drug: Pemigatinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 4, 2017): 46
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 25, 2022
• Estimated Primary Completion Date: July 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Documented lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to FGFR1 activation, based on standard diagnostic cytogenetic evaluation performed locally, before signing informed consent for this study.

• Eligible subjects must:

  • Have relapsed after stem cell transplantation or after other disease modifying therapy, OR
  • Not be current candidates for stem cell transplantation or other disease modifying therapies.
• Note: All relapsed/refractory subjects must have evidence of either cytogenetic or hematological disease and have no evidence of residual toxicity (eg, graft-versus-host disease requiring treatment).
• Life expectancy ≥ 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

• Prior receipt of a selective FGFR inhibitor.
• History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, except calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
• Current evidence of corneal disorder/keratopathy, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis, as confirmed by ophthalmologic examination.
• Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.

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; 1.855.463.3463; globalmedinfo@incyte.com

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

• Listed Location Countries: Austria, Belgium, Canada, France, Germany, Italy, Japan, Spain, Switzerland, United Kingdom, United States

Administrative Information

• NCT Number: NCT03011372
• Other Study ID Numbers: INCB 54828-203
• Has Data Monitoring Committee: No

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: Ekaterine Asatiani, MD; Incyte Corporation

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