Efficacy and Safety of Pemigatinib in Previously Treated... | NCT03822117 | Trialant
NCT03822117
Sponsor
Incyte Corporation
Status
Terminated
Last Update Posted
Nov 4, 2025Actual
Enrollment
111Actual
Phase
Phase 2
Conditions
Solid Tumor Malignancy
Interventions
Pemigatinib
Countries
United States
Denmark
France
Germany
Israel
Italy
Japan
South Korea
Spain
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03822117
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 54828-207
Secondary IDs
ID
Type
Description
Link
2018-004768-69
EudraCT Number
Brief Title
Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
Official Title
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
A business decision was made to to discontinue further enrollment. There were no safety concerns that contributed to this decision.
Expanded Access Info
YesNCT03906357No longer available
Start Date
Oct 17, 2019Actual
Primary Completion Date
Mar 29, 2022Actual
Completion Date
Mar 29, 2022Actual
First Submitted Date
Jan 28, 2019
First Submission Date that Met QC Criteria
Jan 28, 2019
First Posted Date
Jan 30, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Feb 16, 2023
Results First Submitted that Met QC Criteria
Feb 16, 2023
Results First Posted Date
Mar 15, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 20, 2025
Last Update Posted Date
Nov 4, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations.
Cohort A (Solid tumor malignancies with FGFR1-3 in frame fusions; any FGFR2 rearrangement; FGFR1/3 rearrangement with known partner*). Cohort B (Solid tumor malignancies with known or likely activating mutations (excluding kinase domain) in FGFR1-3) Cohort C (Solid tumor malignancies with FGFR1-3 known activating mutations in kinase domain; FGFR1-3 putatively activating mutations; other FGFR1/3 rearrangements* (not eligible for Cohort A)).
*Only FGFR fusions or rearrangements with an intact kinase domain are eligible
Drug: Pemigatinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pemigatinib
Drug
Pemigatinib administered orally once daily (QD).
Pemigatinib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR), Defined as the Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Based on RECIST v1.1 or RANO, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1): CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per Response Assessment in Neuro-Oncology (RANO; for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.
up to 483 days
ORR, Defined as the Percentage of Participants With a Best Overall Response of CR or PR Based on RECIST v1.1 or RANO, in Participants With Known or Likely Activating FGFR1-3 Mutations
Per RECIST v1.1: CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per RANO (for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.
up to 449 days
Secondary Outcomes
Measure
Description
Time Frame
Progression-free Survival (PFS) in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
PFS was defined as the time from the first dose until progressive disease (according to RECIST v1.1 or RANO for participants with primary brain tumors and assessed by an independent centralized radiological review committee) or death (whichever occurred first).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic or is surgically unresectable.
Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors). Tumor lesions located in a previously irradiated area or in an area subjected to other loco-regional therapy are considered measureable if progression has been clearly demonstrated in the lesion.
Documentation of an FGFR1-3 gene mutation or translocation.
Objective progression after at least 1 prior therapy and no therapy available that is likely to provide clinical benefit. Participants who are intolerant to or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit.
Eastern Cooperative Oncology Group performance status 0 to 2.
Baseline archival tumor specimen (if less than 24 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or approximately 15 unstained slides from biopsy or resection of primary tumor or metastasis.
Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
Prior receipt of a selective FGFR inhibitor in the past 6 months.
Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of pemigatinib.
Cannot be a candidate for potentially curative surgery.
Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
Radiation therapy administered within 2 weeks of enrollment/first dose of study treatment.
Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
Known additional malignancy that is progressing or requires active treatment.
History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
Clinically significant or uncontrolled cardiac disease.
Active chronic or current infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment within 2 weeks before enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed).
Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (defined as elevated transaminases or cirrhosis; chronic HBV/HCV infection with no cirrhosis and no elevated transaminases is allowed).
Known HIV infection.
Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or five half-lives (whichever is longer) before the first dose of study drug/treatment.
Rodon J, Damian S, Furqan M, Garcia-Donas J, Imai H, Italiano A, Spanggaard I, Ueno M, Yokota T, Veronese ML, Oliveira N, Li X, Gilmartin A, Schaffer M, Goyal L. Pemigatinib in previously treated solid tumors with activating FGFR1-FGFR3 alterations: phase 2 FIGHT-207 basket trial. Nat Med. 2024 Jun;30(6):1645-1654. doi: 10.1038/s41591-024-02934-7. Epub 2024 May 6.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
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.
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.
This study enrolled participants at 49 study sites in the United States, South Korea, United Kingdom, France, Italy, Israel, Germany, Spain, Denmark, and Japan.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements
Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 15, 2021
Feb 16, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
This study consists of 3 cohorts that will have study drug administered in parallel, Cohort A, Cohort B, and Cohort C. There is no difference in the treatment regimen between the cohorts.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
INCB054828
up to 532 days
Duration of Response (DOR), Defined as the First CR or PR Assessment Until Progressive Disease (PD) or Death, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
Assessment was by an independent centralized radiological review committee; response was confirmed. Per RECIST v1.1: CR: disappearance of all target (TLs)/non-target lesions (NTLs); no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of TLs, taking as a reference the baseline sum diameters; no new lesions; no progression of NTLs. PD: progression of a TL/NTL or presence of new lesion. Per RANO (participants with primary brain tumors): CR: disappearance of all enhancing lesions (ELs); stable/improved non-enhancing lesions (NELs); stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable ELs; no progression of non-measurable disease; stable/improved NELs; stable/improved clinically. PD: >25% increase in sum of perpendicular diameters of all measurable ELs; significant increase of NELs; new lesions; clear clinical deterioration; failure to return for evaluation due to death/deteriorating condition.
up to 24.90 months
Overall Survival in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
Overall survival was defined as the time from the first dose of study drug to death of any cause.
up to 532 days
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-related Adverse Event (AE)
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study treatment. Treatment-related AEs were defined as TEAEs judged as related by the investigator or with a missing causality.
up to 651 days
Phoenix
Arizona
85054
United States
The University of Arizona Cancer Center
Tucson
Arizona
85724
United States
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange
California
92868
United States
Stanford Cancer Center
Palo Alto
California
94304
United States
John Wayne Cancer Institute
Santa Monica
California
90404
United States
St. Joseph Heritage Healthcare
Santa Rosa
California
95403
United States
Florida Cancer Specialists & Research Institute
Fort Myers
Florida
33901
United States
Mayo Clinic Jacksonville
Jacksonville
Florida
32224
United States
Florida Cancer Specialists
St. Petersburg
Florida
33705
United States
Florida Cancer Specialists
Tallahassee
Florida
32308
United States
Florida Cancer Specialists
West Palm Beach
Florida
33401
United States
Illinois Cancer Specialists
Arlington Heights
Illinois
60005
United States
Edward H Kaplan & Associates
Skokie
Illinois
60076
United States
Carle Cancer Center
Urbana
Illinois
61801
United States
Cancer Treatment Centers of America
Zion
Illinois
60099
United States
Indiana University Health - Arnett Cancer Care
Lafayette
Indiana
47904
United States
University of Iowa
Iowa City
Iowa
52242
United States
University of Kansas Cancer Center
Westwood
Kansas
66205
United States
Ochsner Clinic
New Orleans
Louisiana
70121
United States
Central Maine Medical Center
Lewiston
Maine
04240
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Umass Memorial Medical Center, Inc.
Worcester
Massachusetts
01655
United States
Mayo Clinic Rochester
Rochester
Minnesota
55905
United States
Comprehensive Cancer Centers of Nevada
Las Vegas
Nevada
89148
United States
Dartmouth Hitchcock Medical Center
Lebanon
New Hampshire
03756
United States
Summit Medical Group
Florham Park
New Jersey
07932
United States
Winthrop University Hospital
Mineola
New York
11501
United States
Oncology Specialists of Charlotte
Charlotte
North Carolina
28204
United States
Duke Cancer Center
Durham
North Carolina
27710
United States
Wake Forest Baptist Medical Center
Winston-Salem
North Carolina
27157
United States
Stephenson Cancer Center
Oklahoma City
Oklahoma
73104
United States
Southwestern Regional Medical Center
Tulsa
Oklahoma
74133
United States
Cancer Institute of Greenville Health System
Greenville
South Carolina
29605
United States
The West Clinic Pc
Germantown
Tennessee
38138
United States
University of Texas Southwestern Medical Center
Dallas
Texas
75390
United States
Houston Methodist Hospital
Houston
Texas
77030
United States
Joe Arrington Cancer Center
Lubbock
Texas
79410
United States
Virginia Cancer Specialists, Pc
Fairfax
Virginia
22031
United States
Virginia Oncology Associates-Lake Wright
Norfolk
Virginia
23502
United States
Seattle Cancer Care Alliance
Seattle
Washington
98109
United States
Multicare Institute For Research & Innovation
Tacoma
Washington
98405
United States
West Virginia University Hospitals Inc
Morgantown
West Virginia
26506
United States
University of Wisconsin Carbone Cancer Center
Madison
Wisconsin
53792
United States
The Finsen Centre National Hospital
Copenhagen
02100
Denmark
Institut Bergonie
Bordeaux
33000
France
CENTRE GEORGES FRAN�OIS LECLERC
Dijon
21079
France
Centre Antoine Lacassagne
Nice
06189
France
Hospital Saint Louis
Paris
75010
France
A.P.H. Paris Hopital Cochin
Paris
75014
France
Institut Universitaire Du Cancer de Toulouse Oncopole
Toulouse
31059
France
Universitatsklinikum Koln
Cologne
50937
Germany
University Medical Center Freiburg
Freiburg im Breisgau
79106
Germany
University Medical Centre Hamburg-Eppendorf, Centre of Oncology
Hamburg
20246
Germany
University Hospital Grosshadern Munich
Munich
81377
Germany
Universitaetsklinikum in Tubingen
Tübingen
72076
Germany
Ha Emek Medical Center
Afula
18101
Israel
Rambam Health Care Campus
Haifa
3525408
Israel
Hadassah Hebrew University Medical Center Ein Karem Hadassah
Jerusalem
90000
Israel
Rabin Medical Center - Beilinson Hospital
Petah Tikva
4841492
Israel
Assaf Harofeh Medical Center
Ẕerifin
7030000
Israel
L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI
Bologna
40138
Italy
Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
Candiolo
10060
Italy
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan
20133
Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale
Naples
80131
Italy
Istituto Nazionale Tumori Regina Elena Irccs
Roma
00144
Italy
Centro Ricerche Cliniche Di Verona (Crc)
Verona
37134
Italy
National Hospital Organization Kyushu Cancer Center
Fukuoka
811-1395
Japan
Kanazawa University Hospital
Ishikawa
920-8641
Japan
Kobe University Hospital
Kobe
650-0017
Japan
Tohoku University Hospital
Sendai
980-8574
Japan
Keio University Hospital
Shinjuku-ku
160-8582
Japan
Shizuoka Cancer Center
Shizuoka
411-8777
Japan
Kanagawa Cancer Center
Yokohama
241-8515
Japan
National Cancer Center
Goyang-si
10408
South Korea
Seoul National University Bundang Hospital
Seongnam-si
13620
South Korea
Severance Hospital Yonsei University Health System
Seoul
03722
South Korea
Samsung Medical Center
Seoul
06351
South Korea
Hospital General Universitario Vall D Hebron
Barcelona
08035
Spain
Hospital Clinic I Provincial
Barcelona
08036
Spain
Centro Integral Oncologico Clara Campal (Ciocc)
Madrid
28050
Spain
Hospital Regional Universitario de Malaga
Málaga
29010
Spain
Clinica Universidad de Navarra (Cun)
Pamplona
31008
Spain
Hospital Universitario Marques de Valdecilla
Santander
39008
Spain
Hospital Universitario Y Politcnico de La Fe
Valencia
46026
Spain
Inselspital - Universitaetsspital Bern
Bern
03010
Switzerland
Universitatsspital Zurich
Zurich
08091
Switzerland
University College London Hospitals (Uclh)
London
NW1 2PG
United Kingdom
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London
W12 0HS
United Kingdom
Sarah Cannon Research Institute
London
W1G 6AD
United Kingdom
FG001
Cohort B: Known or Likely Activating FGFR1-3 Mutations
Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
FG002
Cohort C: Other FGFR Mutations or Arrangements
Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
FG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
FG00049 subjects
FG00132 subjects
FG00226 subjects
FG0034 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG00049 subjects
FG00132 subjects
FG00226 subjects
FG0034 subjects
Type
Comment
Reasons
Death
FG00018 subjects
FG00117 subjects
FG00212 subjects
FG0034 subjects
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG0030 subjects
Study Terminated by Sponsor
FG00025 subjects
FG00111 subjects
FG0026 subjects
FG0030 subjects
Withdrawal by Subject
FG0004 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
Disease Progression
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
Never Returned to Hospital
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements
Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
BG001
Cohort B: Known or Likely Activating FGFR1-3 Mutations
Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
BG002
Cohort C: Other FGFR Mutations or Arrangements
Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
BG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00049
BG00132
BG00226
BG0034
BG004111
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00059.4± 11.51
BG00166.0± 10.04
BG00261.5± 13.32
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00028
BG00119
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG00038
BG00120
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0001
BG0011
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Objective Response Rate (ORR), Defined as the Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Based on RECIST v1.1 or RANO, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1): CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per Response Assessment in Neuro-Oncology (RANO; for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.
Efficacy Evaluable Population: all enrolled participants in Cohorts A, B, and C who received at least 1 dose of pemigatinib. Confidence interval was calculated based on the exact method for binomial distribution.
Posted
Number
95% Confidence Interval
percentage of participants
up to 483 days
ID
Title
Description
OG000
Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements
Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG001
Cohort B: Known or Likely Activating FGFR1-3 Mutations
Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG002
Cohort C: Other FGFR Mutations or Arrangements
Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00049
OG0010
OG0020
OG003
Title
Denominators
Categories
Title
Measurements
OG00026.5(14.95 to 41.08)
Primary
ORR, Defined as the Percentage of Participants With a Best Overall Response of CR or PR Based on RECIST v1.1 or RANO, in Participants With Known or Likely Activating FGFR1-3 Mutations
Per RECIST v1.1: CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per RANO (for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.
Efficacy Evaluable Population. Confidence interval was calculated based on the exact method for binomial distribution.
Posted
Number
95% Confidence Interval
percentage of participants
up to 449 days
ID
Title
Description
OG000
Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements
Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Secondary
Progression-free Survival (PFS) in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
PFS was defined as the time from the first dose until progressive disease (according to RECIST v1.1 or RANO for participants with primary brain tumors and assessed by an independent centralized radiological review committee) or death (whichever occurred first).
Efficacy Evaluable Population. The 95% confidence interval is calculated using the Brookmeyer and Crowley's method.
Posted
Median
95% Confidence Interval
months
up to 532 days
ID
Title
Description
OG000
Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements
Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG001
Cohort B: Known or Likely Activating FGFR1-3 Mutations
Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Secondary
Duration of Response (DOR), Defined as the First CR or PR Assessment Until Progressive Disease (PD) or Death, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
Assessment was by an independent centralized radiological review committee; response was confirmed. Per RECIST v1.1: CR: disappearance of all target (TLs)/non-target lesions (NTLs); no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of TLs, taking as a reference the baseline sum diameters; no new lesions; no progression of NTLs. PD: progression of a TL/NTL or presence of new lesion. Per RANO (participants with primary brain tumors): CR: disappearance of all enhancing lesions (ELs); stable/improved non-enhancing lesions (NELs); stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable ELs; no progression of non-measurable disease; stable/improved NELs; stable/improved clinically. PD: >25% increase in sum of perpendicular diameters of all measurable ELs; significant increase of NELs; new lesions; clear clinical deterioration; failure to return for evaluation due to death/deteriorating condition.
Efficacy Evaluable Population. The 95% confidence interval is calculated using the Brookmeyer and Crowley's method. Only participants with a CR or PR were analyzed.
Posted
Median
95% Confidence Interval
months
up to 24.90 months
ID
Title
Description
OG000
Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements
Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Secondary
Overall Survival in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
Overall survival was defined as the time from the first dose of study drug to death of any cause.
Efficacy Evaluable Population. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method.
Posted
Median
95% Confidence Interval
months
up to 532 days
ID
Title
Description
OG000
Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements
Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG001
Cohort B: Known or Likely Activating FGFR1-3 Mutations
Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG002
Cohort C: Other FGFR Mutations or Arrangements
Secondary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-related Adverse Event (AE)
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study treatment. Treatment-related AEs were defined as TEAEs judged as related by the investigator or with a missing causality.
Safety Population: all enrolled participants who received at least 1 dose of pemigatinib
Posted
Count of Participants
Participants
up to 651 days
ID
Title
Description
OG000
Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements
Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG001
Cohort B: Known or Likely Activating FGFR1-3 Mutations
Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Time Frame
up to 651 days
Description
Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements
Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
18
49
21
49
49
49
EG001
Cohort B: Known or Likely Activating FGFR1-3 Mutations
Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
17
32
7
32
32
32
EG002
Cohort C: Other FGFR Mutations or Arrangements
Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
13
26
10
26
26
26
EG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
4
4
2
4
4
4
EG004
Total
Total
52
111
40
111
111
111
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG0030 events0 affected4 at risk
EG0043 events3 affected111 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0002 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Corneal erosion
Eye disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Cutaneous calcification
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Fascial infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Fatigue
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected32 at risk
EG0022 events1 affected26 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
General physical health deterioration
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected32 at risk
EG0022 events2 affected26 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Headache
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected26 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Implant site infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Long QT syndrome
Cardiac disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Oedema peripheral
General disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24
Systematic Assessment
EG0003 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Post procedural haematuria
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Sepsis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0002 events2 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Stent malfunction
Product Issues
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Stevens-Johnson syndrome
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Ureteric obstruction
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected26 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00010 events7 affected49 at risk
EG0013 events3 affected32 at risk
EG0025 events5 affected26 at risk
EG0030 events0 affected4 at risk
EG00418 events15 affected111 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected49 at risk
EG0012 events1 affected32 at risk
EG0023 events3 affected26 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 24
Systematic Assessment
EG0008 events6 affected49 at risk
EG0015 events5 affected32 at risk
EG0023 events3 affected26 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG00020 events20 affected49 at risk
EG00121 events17 affected32 at risk
EG0028 events8 affected26 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0009 events8 affected49 at risk
EG0014 events4 affected32 at risk
EG0022 events2 affected26 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG00012 events11 affected49 at risk
EG00114 events11 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 24
Systematic Assessment
EG0009 events5 affected49 at risk
EG0015 events4 affected32 at risk
EG0026 events5 affected26 at risk
EG003
Asthenia
General disorders
MedDRA 24
Systematic Assessment
EG0008 events8 affected49 at risk
EG00115 events11 affected32 at risk
EG0029 events8 affected26 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected49 at risk
EG0014 events4 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 24
Systematic Assessment
EG0002 events2 affected49 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected26 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 24
Systematic Assessment
EG00010 events10 affected49 at risk
EG0013 events3 affected32 at risk
EG0025 events5 affected26 at risk
EG003
COVID-19
Infections and infestations
MedDRA 24
Systematic Assessment
EG0004 events4 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0015 events2 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0002 events2 affected49 at risk
EG0012 events2 affected32 at risk
EG0024 events3 affected26 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00020 events18 affected49 at risk
EG00118 events13 affected32 at risk
EG0026 events6 affected26 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected49 at risk
EG0017 events6 affected32 at risk
EG0022 events2 affected26 at risk
EG003
Cystitis
Infections and infestations
MedDRA 24
Systematic Assessment
EG0003 events3 affected49 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG00014 events10 affected49 at risk
EG00115 events12 affected32 at risk
EG0025 events5 affected26 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected49 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Depression
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00028 events19 affected49 at risk
EG00130 events17 affected32 at risk
EG0027 events7 affected26 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0005 events5 affected49 at risk
EG0013 events1 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Dry eye
Eye disorders
MedDRA 24
Systematic Assessment
EG00013 events12 affected49 at risk
EG00110 events9 affected32 at risk
EG0025 events4 affected26 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00015 events13 affected49 at risk
EG00113 events11 affected32 at risk
EG0028 events7 affected26 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0007 events6 affected49 at risk
EG0017 events6 affected32 at risk
EG0026 events5 affected26 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 24
Systematic Assessment
EG00012 events10 affected49 at risk
EG00117 events14 affected32 at risk
EG0027 events6 affected26 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0015 events4 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected49 at risk
EG0015 events4 affected32 at risk
EG0022 events2 affected26 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0005 events5 affected49 at risk
EG0013 events3 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0005 events4 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 24
Systematic Assessment
EG0004 events3 affected49 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Fatigue
General disorders
MedDRA 24
Systematic Assessment
EG00014 events10 affected49 at risk
EG00111 events9 affected32 at risk
EG0024 events4 affected26 at risk
EG003
Headache
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0005 events5 affected49 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected26 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0004 events2 affected49 at risk
EG0013 events3 affected32 at risk
EG0028 events3 affected26 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected49 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG00072 events45 affected49 at risk
EG00151 events27 affected32 at risk
EG00227 events17 affected26 at risk
EG003
Hypertension
Vascular disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected49 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected49 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0005 events5 affected49 at risk
EG0012 events1 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0005 events4 affected49 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0004 events4 affected49 at risk
EG0013 events3 affected32 at risk
EG0024 events2 affected26 at risk
EG003
Hypotension
Vascular disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected49 at risk
EG0016 events4 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 24
Systematic Assessment
EG0004 events4 affected49 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Keratitis
Eye disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected49 at risk
EG0010 events0 affected32 at risk
EG0022 events2 affected26 at risk
EG003
Lipase increased
Investigations
MedDRA 24
Systematic Assessment
EG0003 events2 affected49 at risk
EG0011 events1 affected32 at risk
EG0023 events2 affected26 at risk
EG003
Malaise
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0014 events4 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected49 at risk
EG0012 events1 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0004 events4 affected49 at risk
EG0014 events4 affected32 at risk
EG0022 events2 affected26 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0007 events7 affected49 at risk
EG0014 events4 affected32 at risk
EG0022 events2 affected26 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0004 events4 affected49 at risk
EG0014 events4 affected32 at risk
EG0022 events2 affected26 at risk
EG003
Nail infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0012 events2 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00012 events11 affected49 at risk
EG00112 events8 affected32 at risk
EG0027 events6 affected26 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Oedema peripheral
General disorders
MedDRA 24
Systematic Assessment
EG0006 events6 affected49 at risk
EG0015 events5 affected32 at risk
EG0022 events2 affected26 at risk
EG003
Onychalgia
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected49 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0003 events2 affected49 at risk
EG0016 events5 affected32 at risk
EG0023 events3 affected26 at risk
EG003
Onychomadesis
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0008 events7 affected49 at risk
EG0016 events6 affected32 at risk
EG0024 events4 affected26 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected49 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24
Systematic Assessment
EG0008 events7 affected49 at risk
EG0010 events0 affected32 at risk
EG0023 events3 affected26 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG00015 events13 affected49 at risk
EG00111 events8 affected32 at risk
EG0025 events5 affected26 at risk
EG003
Paronychia
Infections and infestations
MedDRA 24
Systematic Assessment
EG0005 events5 affected49 at risk
EG0017 events6 affected32 at risk
EG0023 events3 affected26 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected49 at risk
EG0014 events4 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Pyrexia
General disorders
MedDRA 24
Systematic Assessment
EG0002 events2 affected49 at risk
EG0013 events3 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0003 events3 affected49 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0013 events3 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Serous retinal detachment
Eye disorders
MedDRA 24
Systematic Assessment
EG0006 events5 affected49 at risk
EG0013 events3 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00039 events27 affected49 at risk
EG00125 events17 affected32 at risk
EG00221 events13 affected26 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 24
Systematic Assessment
EG0001 events1 affected49 at risk
EG0012 events2 affected32 at risk
EG0022 events2 affected26 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 24
Systematic Assessment
EG0003 events2 affected49 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 24
Systematic Assessment
EG0004 events4 affected49 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24
Systematic Assessment
EG0006 events6 affected49 at risk
EG0015 events5 affected32 at risk
EG0025 events4 affected26 at risk
EG003
Vision blurred
Eye disorders
MedDRA 24
Systematic Assessment
EG0005 events5 affected49 at risk
EG0014 events3 affected32 at risk
EG0020 events0 affected26 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 24
Systematic Assessment
EG0002 events1 affected49 at risk
EG0011 events1 affected32 at risk
EG0022 events2 affected26 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24
Systematic Assessment
EG00014 events10 affected49 at risk
EG0016 events5 affected32 at risk
EG0025 events5 affected26 at risk
EG003
Weight decreased
Investigations
MedDRA 24
Systematic Assessment
EG0009 events8 affected49 at risk
EG0016 events6 affected32 at risk
EG0022 events2 affected26 at risk
EG003
Xerosis
General disorders
MedDRA 24
Systematic Assessment
EG0000 events0 affected49 at risk
EG0012 events2 affected32 at risk
EG0021 events1 affected26 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000705477
pemigatinib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
48.0
± 14.45
BG00461.4± 12.11
14
BG0031
BG00462
Male
BG00021
BG00113
BG00212
BG0033
BG00449
16
BG0030
BG00474
Black or African American
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
Asian
Title
Measurements
BG0009
BG0019
BG0027
BG0034
BG00429
Participant Declined to Provide
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0041
Not Available
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0041
Not Required in Country of Origin
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0041
Missing
Title
Measurements
BG0001
BG0011
BG0022
BG0030
BG0044
1
BG0030
BG0043
Not Hispanic or Latino
Title
Measurements
BG00044
BG00125
BG00220
BG0033
BG00492
Not Reported
Title
Measurements
BG0002
BG0012
BG0023
BG0031
BG0048
Unknown
Title
Measurements
BG0001
BG0012
BG0020
BG0030
BG0043
Captured as "Other"
Title
Measurements
BG0000
BG0011
BG0020
BG0030
BG0041
Missing
Title
Measurements
BG0001
BG0011
BG0022
BG0030
BG0044
0
OG001
Cohort B: Known or Likely Activating FGFR1-3 Mutations
Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG002
Cohort C: Other FGFR Mutations or Arrangements
Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Units
Counts
Participants
OG0000
OG00132
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG0019.4(1.98 to 25.02)
OG002
Cohort C: Other FGFR Mutations or Arrangements
Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00049
OG00132
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG0004.53(3.58 to 6.28)
OG0013.68(2.07 to 4.47)
OG001
Cohort B: Known or Likely Activating FGFR1-3 Mutations
Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG002
Cohort C: Other FGFR Mutations or Arrangements
Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00013
OG0013
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG0007.79(4.17 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
OG0016.93(4.01 to NA)The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Units
Counts
Participants
OG00049
OG00132
OG0020
OG0030
Title
Denominators
Categories
Title
Measurements
OG00017.48(7.79 to NA)The upper limit of the confidence interval was not estimable because too few participants had died.
OG00111.37(6.57 to NA)The upper limit of the confidence interval was not estimable because too few participants had died.
OG002
Cohort C: Other FGFR Mutations or Arrangements
Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
OG003
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.