Solid Tumors Clinical Trial
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)
Verified date | May 2020 |
Source | Incyte Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the safety and tolerability of pemigatinib in Japanese subjects with advanced malignancies.
Status | Completed |
Enrollment | 44 |
Est. completion date | March 4, 2020 |
Est. primary completion date | March 4, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Japan | Aichi Cancer Center Hospital | Aichi | |
Japan | Chiba Cancer Center | Chiba | |
Japan | National Cancer Central Hospital East | Chiba | |
Japan | Kyusyu Cancer Center | Fukuoka | |
Japan | Kanazawa University Hospital | Ishikawa | |
Japan | Kanagawa Cancer Center | Kanagawa | |
Japan | Osaka International Cancer Institute | Osaka | |
Japan | Saitama Cancer Center | Saitama | |
Japan | Hokkaido Cancer Center | Sapporo | |
Japan | Shizuoka Cancer Center | Shizuoka | |
Japan | JFCR Ariake Hospital | Tokyo | |
Japan | National Cancer Central Hospital | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Incyte Corporation |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs) | 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. | Baseline through 30 days after end of treatment, up to approximately 16 months. | |
Secondary | Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Defined as proportion of subjects who meet the response criteria (complete response + partial response) as appropriate for the tumor type. | Baseline and Day 15 of every third treatment cycle, up to approximately 6 months | |
Secondary | Pharmacodynamics of pemigatinib assessed by changes in serum phosphorus level | Analyzed to look for differences that may be associated with response or safety as well as significant changes associated with treatment. | Baseline and protocol-defined timepoints throughout the treatment period, up to approximately 6 months | |
Secondary | Observed Plasma Concentration of pemigatinib | PK parameters will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental (model independent) PK methods. | During the first cycle, up to Day 16 |
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