A Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)

A Phase 1, Open-Label, Dose-Escalation, Dose-Expansion, Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)

The purpose of this study is to evaluate the safety and tolerability of pemigatinib in Japanese subjects with advanced malignancies.

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: Pemigatinib

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan, 464-8681
    • Aichi Cancer Center Hospital
  • Chiba, Japan, 260-8717
    • Chiba Cancer Center
  • Chiba, Japan, 277-8577
    • National Cancer Central Hospital East
  • Fukuoka, Japan, 811-1395
    • Kyusyu Cancer Center
  • Ishikawa, Japan, 920-8641
    • Kanazawa University Hospital
  • Kanagawa, Japan, 241-8515
    • Kanagawa Cancer Center
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Saitama, Japan, 362-0806
    • Saitama Cancer Center
  • Sapporo, Japan, 003-0804
    • Hokkaido Cancer Center
  • Shizuoka, Japan, 411-8777
    • Shizuoka Cancer Center
  • Tokyo, Japan, 104-0045
    • National Cancer Central Hospital
  • Tokyo, Japan, 135-8550
    • JFCR Ariake Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• First generation Japanese; subject was born in Japan and has not lived outside of Japan for a total of > 10 years and subject can trace maternal and paternal Japanese ancestry.
• Part 1: Any histologically confirmed advanced solid tumor malignancy. Subjects enrolled at a lower dose level expansion cohort are required to have documented FGF/FGFR alterations and baseline and on-treatment tumor biopsy for testing of biomarkers.
• Part 2: Any histologically confirmed advanced solid tumor malignancy with a FGF/FGFR alteration
• Advanced or metastatic and recurrent cancer where an appropriate treatment option is not available.
• Life expectancy > 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status: Part 1: 0 or 1; Part 2: 0, 1, or 2.
• Genomic testing is mandatory for all enrolled subjects. Archival tumor specimen of at least 7 slides or willingness to undergo a pretreatment tumor biopsy to provide a tumor block or at least 7 unstained slides. Archival tumor biopsies are acceptable at baseline and should be no more than 2 years old (preferably less than 1 year old and collected since the completion of the last treatment); subjects with samples older than 2 years old and/or with sequencing report from the central laboratory require approval from the sponsor medical monitor for exemption from tumor biopsy or tumor sample requirement.

Exclusion Criteria:

• Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives (whichever is longer) before first dose of study drug (6 weeks for mitomycin-C or nitrosoureas, 7 days for tyrosine kinase inhibitors).
• Prior receipt of a selective FGFR inhibitor.
• Laboratory and medical history parameters outside Protocol-defined range.
• History and/or current evidence of ectopic mineralization/calcification including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcification.
• Current evidence of corneal disorder/keratopathy including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, confirmed by ophthalmologic examination.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pemigatinib; Part 1 is an open-label dose-escalation design based on observing each dose level for a period of 21 days. Part 2 will evaluate the recommended dose determined in Part 1.	Drug: Pemigatinib; Pemigatinib at the protocol-defined dose administered once daily.; Other Names: INCB054828

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)	An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.	Baseline through 30 days after end of treatment, up to approximately 16 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Defined as proportion of subjects who meet the response criteria (complete response + partial response) as appropriate for the tumor type.	Baseline and Day 15 of every third treatment cycle, up to approximately 6 months
Pharmacodynamics of pemigatinib assessed by changes in serum phosphorus level	Analyzed to look for differences that may be associated with response or safety as well as significant changes associated with treatment.	Baseline and protocol-defined timepoints throughout the treatment period, up to approximately 6 months
Observed Plasma Concentration of pemigatinib	PK parameters will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental (model independent) PK methods.	During the first cycle, up to Day 16

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Ekaterine Asatiani, MD, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): March 4, 2020
• Study Completion (Actual): March 4, 2020

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Solid tumor; malignancy; fibroblast growth factor receptor (FGFR); fibroblast growth factor (FGF)/FGFR alteration
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: INCB 54828-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes