Status:
COMPLETED
A Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)
Lead Sponsor:
Incyte Corporation
Conditions:
Solid Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE1
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
- 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
- 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.
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2020
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03235570
Start Date
August 1 2017
End Date
March 4 2020
Last Update
May 29 2020
Active Locations (12)
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1
Aichi Cancer Center Hospital
Aichi, Japan, 464-8681
2
Chiba Cancer Center
Chiba, Japan, 260-8717
3
National Cancer Central Hospital East
Chiba, Japan, 277-8577
4
Kyusyu Cancer Center
Fukuoka, Japan, 811-1395