A Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)
- Registration Number
- NCT03235570
- Lead Sponsor
- Incyte Corporation
- Brief Summary
The purpose of this study is to evaluate the safety and tolerability of pemigatinib in Japanese subjects with advanced malignancies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pemigatinib 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.
- Primary Outcome Measures
Name Time Method Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs) Baseline through 30 days after end of treatment, up to approximately 16 months. 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.
- Secondary Outcome Measures
Name Time Method Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Baseline and Day 15 of every third treatment cycle, up to approximately 6 months Defined as proportion of subjects who meet the response criteria (complete response + partial response) as appropriate for the tumor type.
Pharmacodynamics of pemigatinib assessed by changes in serum phosphorus level Baseline and protocol-defined timepoints throughout the treatment period, up to approximately 6 months Analyzed to look for differences that may be associated with response or safety as well as significant changes associated with treatment.
Observed Plasma Concentration of pemigatinib During the first cycle, up to Day 16 PK parameters will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental (model independent) PK methods.
Trial Locations
- Locations (12)
Chiba Cancer Center
🇯🇵Chiba, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Japan
Saitama Cancer Center
🇯🇵Saitama, Japan
JFCR Ariake Hospital
🇯🇵Tokyo, Japan
Hokkaido Cancer Center
🇯🇵Sapporo, Japan
Aichi Cancer Center Hospital
🇯🇵Aichi, Japan
National Cancer Central Hospital East
🇯🇵Chiba, Japan
Kanagawa Cancer Center
🇯🇵Kanagawa, Japan
Kyusyu Cancer Center
🇯🇵Fukuoka, Japan
Kanazawa University Hospital
🇯🇵Ishikawa, Japan
Shizuoka Cancer Center
🇯🇵Shizuoka, Japan
National Cancer Central Hospital
🇯🇵Tokyo, Japan