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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03235570
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

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
Solid Tumors Drug: Pemigatinib Phase 1

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Study Type : Interventional
Estimated Enrollment : 54 participants
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 : August 1, 2017
Estimated Primary Completion Date : June 13, 2020
Estimated Study Completion Date : October 13, 2020

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 Name: INCB054828




Primary Outcome Measures :
  1. Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235570


Contacts
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Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

Locations
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Japan
Aichi Cancer Center Hospital Recruiting
Aichi, Japan, 464-8681
Contact: Study Coordinator    +81-052-762-6111      
Chiba Cancer Center Recruiting
Chiba, Japan, 260-8717
Contact: Study Coordinator    +81-043-264-5431      
National Cancer Central Hospital East Recruiting
Chiba, Japan, 277-8577
Contact: Study Coordinator    +81-04-7133-1111      
Kanagawa Cancer Center Recruiting
Kanagawa, Japan, 241-8515
Contact: Study Coordinator    +81-045-520-2222      
Osaka International Cancer Institute Recruiting
Osaka, Japan, 541-8567
Contact: Study Coordinator    +81-06-6945-1181      
Saitama Cancer Center Recruiting
Saitama, Japan, 362-0806
Contact: Study Coordinator    +81-048-722-1111      
Hokkaido Cancer Center Recruiting
Sapporo, Japan, 003-0804
Contact: Study Coordinator    +81-011-811-9111      
Shizuoka Cancer Center Recruiting
Shizuoka, Japan, 411-8777
Contact: Study Coordinator    +81-55-989-5222      
National Cancer Central Hospital Recruiting
Tokyo, Japan, 104-0045
Contact: Study Coordinator    +81-03-3542-2511      
JFCR Ariake Hospital Recruiting
Tokyo, Japan, 135-8550
Contact: Study Coordinator    +81-03-3520-0111      
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Ekaterine Asatiani, MD Incyte Corporation

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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03235570    
Other Study ID Numbers: INCB 54828-102
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Neoplasms
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action