Overview
A Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)
Status:
Completed
Completed
Trial end date:
2020-03-04
2020-03-04
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the safety and tolerability of pemigatinib in Japanese subjects with advanced malignancies.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Incyte Corporation
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.