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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 December 2023
• Main ID: NCT03011372
• Date of registration: 04/01/2017
• Prospective Registration: Yes
• Primary sponsor: Incyte Corporation
• Public title: A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)
• Scientific 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)
• Date of first enrolment: April 25, 2017
• Target sample size: 47
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03011372
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Austria, Belgium, Canada, France, Germany, Italy, Japan, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Philomena Collucci, MD
• Affiliation: Incyte Corporation

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

MPN (Myeloproliferative Neoplasms)

Intervention(s)

Drug: Pemigatinib

Primary Outcome(s)

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.]

Secondary Outcome(s)

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]

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.]

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.]

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.]

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.]

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.]

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.]

Secondary ID(s)

INCB 54828-203

Source(s) of Monetary Support

Please refer to primary and secondary sponsors