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

NCT03235570 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: INCB 54828-102
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Solid Tumors

Keywords

Solid tumor; malignancy; fibroblast growth factor receptor (FGFR); fibroblast growth factor (FGF)/FGFR alteration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Pharmacodynamics of pemigatinib assessed by changes in serum phosphorus level

  Baseline and protocol-defined timepoints throughout the treatment period, up to approximately 6 months

• Observed Plasma Concentration of pemigatinib

  During the first cycle, up to Day 16

Study Arms (1)

Pemigatinib

EXPERIMENTAL

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.

Drug: Pemigatinib

Interventions

Pemigatinib DRUG

Pemigatinib at the protocol-defined dose administered once daily.

Also known as: INCB054828

Pemigatinib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (12)

Aichi Cancer Center Hospital

Aichi, 464-8681, Japan

Location

Chiba Cancer Center

Chiba, 260-8717, Japan

Location

National Cancer Central Hospital East

Chiba, 277-8577, Japan

Location

Kyusyu Cancer Center

Fukuoka, 811-1395, Japan

Location

Kanazawa University Hospital

Ishikawa, 920-8641, Japan

Location

Kanagawa Cancer Center

Kanagawa, 241-8515, Japan

Location

Osaka International Cancer Institute

Osaka, 541-8567, Japan

Location

Saitama Cancer Center

Saitama, 362-0806, Japan

Location

Hokkaido Cancer Center

Sapporo, 003-0804, Japan

Location

Shizuoka Cancer Center

Shizuoka, 411-8777, Japan

Location

National Cancer Central Hospital

Tokyo, 104-0045, Japan

Location

JFCR Ariake Hospital

Tokyo, 135-8550, Japan

Location

MeSH Terms

Conditions

Neoplasms; Acrocephalosyndactylia

Interventions

pemigatinib

Condition Hierarchy (Ancestors)

Craniosynostoses; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Syndactyly; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ekaterine Asatiani, MD

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 1, 2017
• Study Start: August 1, 2017
• Primary Completion: March 4, 2020
• Study Completion: March 4, 2020
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (12)