Clinical Trials /

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

NCT03011372

Description:

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.

Related Conditions:
  • Hematopoietic and Lymphoid Cell Neoplasm
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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)

Clinical Trial IDs

  • ORG STUDY ID: INCB 54828-203
  • NCT ID: NCT03011372

Conditions

  • MPN (Myeloproliferative Neoplasms)

Interventions

DrugSynonymsArms
PemigatinibINCB054828Pemigatinib

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
PemigatinibExperimental
  • Pemigatinib

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.

          -  Subjects must be relapsed/refractory. Prior stem cell transplantation is allowed.

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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.
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Duration of response/benefit
Time Frame:Assessed at protocol-defined timepoints through end of study, up to approximately 24 months.
Safety Issue:
Description:Defined as the time from the date when the subject first achieves response/benefit until the date of the first documented disease progression.
Measure: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.
Safety Issue:
Description: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.
Measure:Overall survival
Time Frame:From date of first study drug dose until death due to any cause, assessed up to approximately 24 months.
Safety Issue:
Description: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.
Measure: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
Safety Issue:
Description: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).

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Myeloid neoplasm
  • fibroblast growth factor receptor inhibitor
  • FGFR1 rearrangement
  • 8p11
  • eosinophilia
  • eosinophilic syndrome
  • Lymphoid neoplasm

Last Updated