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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03011372
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : August 21, 2020
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

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: N/A
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 : April 25, 2017
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : November 25, 2022

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

Other Name: INCB054828




Primary Outcome Measures :
  1. 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 Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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. ]
  6. 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.

  7. 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.

  8. 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).



Information from the National Library of Medicine

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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.
  • 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.

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

Locations
Show Show 31 study locations
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Ekaterine Asatiani, MD Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03011372    
Other Study ID Numbers: INCB 54828-203
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
Individual Participant Data (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
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

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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:
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Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases