Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell T… (NCT04526704) | Clinical Trial Compass
CompletedPhase 4
Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib
United States32 participantsStarted 2020-10-20
Plain-language summary
This study is designed to evaluate the discontinuation/re-treatment of pexidartinib therapy in previously treated participants with tenosynovial giant cell tumor (TGCT).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Currently enrolled and on pexidartinib treatment in one of the following studies: Study PLX108-10 (ENLIVEN), Study PLX108-01, Study PL3397-A-A103 or Study PL3397-A-U126.
* 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 an…
What they're measuring
1
Number of Treatment-Free Participants at 12 Months In The Treatment-free/Re-treatment Cohort
Timeframe: Baseline up to 12 months after last participant enrolled in Cohort
2
Number of Treatment-Free Participants at 24 Months In The Treatment-free/Re-treatment Cohort
Timeframe: Baseline up to 24 months after last participant enrolled in Cohort