Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib
NCT ID: NCT04526704
Last Updated: 2024-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
32 participants
INTERVENTIONAL
2020-10-20
2023-07-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Continuation Cohort
Previously-treated participants with TGCT continuing their current dose of pexidartinib treatment.
Pexidartinib
200 mg capsules administered orally twice daily on an empty stomach (at least 1 hour before or at least 2 hours after a meal or snack)
Treatment-Free/Re-Treatment Cohort
Previously-treated participants with TGCT who discontinue pexidartinib treatment (Treatment-Free Period) and had the option to resume pexidartinib treatment at dose at completion of prior study (Re-Treatment Period).
Pexidartinib
200 mg capsules administered orally twice daily on an empty stomach (at least 1 hour before or at least 2 hours after a meal or snack)
Interventions
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Pexidartinib
200 mg capsules administered orally twice daily on an empty stomach (at least 1 hour before or at least 2 hours after a meal or snack)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to complete the PROMIS Physical Function Scale and EQ-5D-5L throughout the study.
* Willing and able to provide written informed consent prior to any study-related procedures and to comply with all study requirements.
* Females of reproductive potential must have a negative urine pregnancy test at Screening/Baseline (to be confirmed by a serum pregnancy test taken on the last treatment visit of their prior study). They are advised to use an effective, non-hormonal method of contraception during treatment with pexidartinib and for 1 month after the last dose. Males with female partners of reproductive potential should be advised to use an effective method of contraception during treatment with pexidartinib and for 1 month after the last dose. Female partners of male patients should concurrently use effective contraceptive methods (hormonal or non-hormonal).
Note: A female is considered of reproductive potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy) with a confirmed by follicle stimulating hormone (FSH) test level \>40 mIU/mL.
* Male participants must not freeze or donate sperm starting at Screening and throughout the study period, and for at least 5 half-lives or 1 month after the final study drug administration, whichever is longer. Female participants must not donate, or retrieve for their own use, ova from the time of Screening and throughout the study treatment period, and for at least 1 month or 5 half-lives after the final study drug administration, whichever is longer.
Exclusion Criteria
* Exposure to another investigational drug or current participation in other therapeutic investigational procedures, besides pexidartinib studies, within 1 month prior to start of study treatment. Any known contraindication to treatment with, including hypersensitivity to, the study drug(s) or excipients in pexidartinib.
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Team Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Honor Health
Scottsdale, Arizona, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Rizzoli-Istituto Ortopedico Rizzoli
Bologna, , Italy
Fondazione IRCC Istituto Nazionale dei Tumori
Milan, , Italy
Leiden University Medical Center (LUMC)
Leiden, , Netherlands
Hospital Sant Pau
Barcelona, , Spain
Hospital Virgen del Rocio
Seville, , Spain
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2020-000192-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PL3397-A-U4003
Identifier Type: -
Identifier Source: org_study_id