Clinical trial NCT03235570: A Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)
Official title: A Phase 1, Open-Label, Dose-Escalation, Dose-Expansion, Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Solid tumor
malignancy
fibroblast growth factor receptor (FGFR)
fibroblast growth factor (FGF)/FGFR alteration
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-01
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)
timeFrame: Baseline through 30 days after end of treatment, up to approximately 16 months.
Secondary outcomes:
measure: Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Baseline and Day 15 of every third treatment cycle, up to approximately 6 months
measure: Pharmacodynamics of pemigatinib assessed by changes in serum phosphorus level
timeFrame: Baseline and protocol-defined timepoints throughout the treatment period, up to approximately 6 months
measure: Observed Plasma Concentration of pemigatinib
timeFrame: During the first cycle, up to Day 16
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Chiba
country: Japan
facility: National Cancer Central Hospital East
city: Fukuoka
country: Japan
facility: Kyusyu Cancer Center
city: Ishikawa
country: Japan
facility: Kanazawa University Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Sapporo
country: Japan
facility: Hokkaido Cancer Center
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: National Cancer Central Hospital
city: Tokyo
country: Japan
facility: JFCR Ariake Hospital
Study officials:
affiliation: Incyte Corporation
name: Ekaterine Asatiani, MD
role: STUDY_DIRECTOR
References: