Solid Tumors
Conditions
Keywords
Solid tumor, malignancy, fibroblast growth factor receptor (FGFR), fibroblast growth factor (FGF)/FGFR alteration
Brief summary
The purpose of this study is to evaluate the safety and tolerability of pemigatinib in Japanese subjects with advanced malignancies.
Interventions
DRUGPemigatinib
Pemigatinib at the protocol-defined dose administered once daily.
Sponsors
Incyte Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Outcome results
None listed