A Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235570
• Other study ID #: INCB 54828-102
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2017
• Est. completion date: March 4, 2020

Study information

• Verified date: May 2020
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of pemigatinib in Japanese subjects with advanced malignancies.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• Pemigatinib
Pemigatinib at the protocol-defined dose administered once daily.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

Japan, 

Outcome

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