Back to resultsA Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)
Primary Purpose
MPN (Myeloproliferative Neoplasms)
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pemigatinib
Sponsored by
About this trial
This is an interventional treatment trial for MPN (Myeloproliferative Neoplasms) focused on measuring Myeloid neoplasm, fibroblast growth factor receptor inhibitor, FGFR1 rearrangement, 8p11, eosinophilia, eosinophilic syndrome, Lymphoid neoplasm
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.
Sites / Locations
- Mayo Clinic Arizona
- City of Hope National Medical Center
- Stanford Cancer Institute
- Emory University - Winship Cancer Institute
- Franciscan St. Francis Health
- Washington University School of Medicine
- Weill Cornell Medical Centers
- Md Anderson Cancer Center
- University of Utah
- Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz
- Medical University of Vienna
- Iii Med. Abteilung For Hematologie and Onkologie Hanuscfhkrankenhaus
- Universitair Ziekenhuis (Uz) Leuven
- Princess Margaret Cancer Center
- Centre Leon Berard
- Chu de Nice - Hospital L Archet
- Hospital Saint Louis
- Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
- University Medical Center Rwth Aachen
- Universitatsklinikum Halle (Saale)
- Universitatsklinikum Jena
- Universitatsklinikum Leipzig
- University Hospital Mannheim
- Johannes Wesling Klinikum Minden
- Ospedale Papa Giovanni Xxiii
- Azienda Ospedaliero-Universitaria Careggi (Aouc)
- Kindai University Hospital
- Ntt Medical Center Tokyo
- Hospital Clinico Universitario de Valencia
- Inselspital - Universitaetsspital Bern
- Universitatsspital Zurich
- Guys and St Thomas Nhs Foundation Trust
- Oxford University Hospitals Nhs Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pemigatinib
Arm Description
Outcomes
Primary Outcome Measures
The proportion of participants who achieve Complete Response (CR) based on response criteria for myeloid/lymphoid neoplasms with FGFR1 rearrangement
Secondary Outcome Measures
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
The proportion of subjects who achieve a complete cytogenetic response (CCyR) as assessed by local analysis and investigator evaluation
The proportion of subjects who achieve a partial cytogenetic response (PCyR) as assessed by local analysis and investigator evaluation
Duration of CR, defined as the time from first assessment of CR to the earlier of disease progression or death due to any cause
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
Progression-free survival (PFS)
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
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03011372
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MPN (Myeloproliferative Neoplasms)
Keywords
Myeloid neoplasm, fibroblast growth factor receptor inhibitor, FGFR1 rearrangement, 8p11, eosinophilia, eosinophilic syndrome, Lymphoid neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pemigatinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pemigatinib
Other Intervention Name(s)
INCB054828
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
Progression-free survival (PFS)
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.
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.
Title
Overall survival
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.
Time Frame
From date of first study drug dose until death due to any cause, assessed up to approximately 24 months.
Title
Safety and tolerability as assessed by frequency, duration, and severity of adverse events
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).
Time Frame
From baseline through 30-35 days after end of treatment, up to 7 months per individual subject
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philomena Collucci, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Stanford Cancer Institute
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Emory University - Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Franciscan St. Francis Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Weill Cornell Medical Centers
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Md Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz
City
Linz
ZIP/Postal Code
04010
Country
Austria
Facility Name
Medical University of Vienna
City
Wien
ZIP/Postal Code
01090
Country
Austria
Facility Name
Iii Med. Abteilung For Hematologie and Onkologie Hanuscfhkrankenhaus
City
Wien
ZIP/Postal Code
01140
Country
Austria
Facility Name
Universitair Ziekenhuis (Uz) Leuven
City
Leuven
ZIP/Postal Code
03000
Country
Belgium
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Chu de Nice - Hospital L Archet
City
Nice Cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Hospital Saint Louis
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
University Medical Center Rwth Aachen
City
Aachen
ZIP/Postal Code
D-52074
Country
Germany
Facility Name
Universitatsklinikum Halle (Saale)
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitatsklinikum Jena
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
University Hospital Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
Ospedale Papa Giovanni Xxiii
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Careggi (Aouc)
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Kindai University Hospital
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Ntt Medical Center Tokyo
City
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Inselspital - Universitaetsspital Bern
City
Bern
ZIP/Postal Code
03010
Country
Switzerland
Facility Name
Universitatsspital Zurich
City
Zurich
ZIP/Postal Code
08091
Country
Switzerland
Facility Name
Guys and St Thomas Nhs Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Oxford University Hospitals Nhs Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing 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.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency
Learn more about this trial
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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