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

Sponsor
Incyte Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03235570
Collaborator
(none)
44
Enrollment
12
Locations
1
Arm
31.1
Actual Duration (Months)
3.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Aug 1, 2017
Actual Primary Completion Date :
Mar 4, 2020
Actual Study Completion Date :
Mar 4, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Pemigatinib
Pemigatinib at the protocol-defined dose administered once daily.
Other Names:
  • INCB054828

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aichi Cancer Center Hospital Aichi Japan 464-8681
    2 Chiba Cancer Center Chiba Japan 260-8717
    3 National Cancer Central Hospital East Chiba Japan 277-8577
    4 Kyusyu Cancer Center Fukuoka Japan 811-1395
    5 Kanazawa University Hospital Ishikawa Japan 920-8641
    6 Kanagawa Cancer Center Kanagawa Japan 241-8515
    7 Osaka International Cancer Institute Osaka Japan 541-8567
    8 Saitama Cancer Center Saitama Japan 362-0806
    9 Hokkaido Cancer Center Sapporo Japan 003-0804
    10 Shizuoka Cancer Center Shizuoka Japan 411-8777
    11 National Cancer Central Hospital Tokyo Japan 104-0045
    12 JFCR Ariake Hospital Tokyo Japan 135-8550

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Ekaterine Asatiani, MD, Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT03235570
    Other Study ID Numbers:
    • INCB 54828-102
    First Posted:
    Aug 1, 2017
    Last Update Posted:
    May 29, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Incyte Corporation
    Solid tumor
    malignancy
    fibroblast growth factor receptor (FGFR)
    fibroblast growth factor (FGF)/FGFR alteration
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of May 29, 2020