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

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ClinicalTrials.gov Identifier: NCT03011372
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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.

Condition or disease Intervention/treatment Phase
MPN (Myeloproliferative Neoplasms) Drug: Pemigatinib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 26, 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pemigatinib Drug: Pemigatinib

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

Participants enrolled under Protocol Amendment 5 dated 17th May 2018 will receive the drug once a day by mouth continuously.

Other Name: INCB054828




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011372


Contacts
Contact: Incyte Corporation Call Center 1.855.463.3463
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

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Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Ekaterine Asatiani, MD Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03011372     History of Changes
Other Study ID Numbers: INCB 54828-203
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018

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

Keywords provided by Incyte Corporation:
Myeloid neoplasm
fibroblast growth factor receptor inhibitor
FGFR1 rearrangement
8p11
eosinophilia
eosinophilic syndrome
Lymphoid neoplasm

Additional relevant MeSH terms:
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases