Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This study is designed to evaluate the discontinuation/re-treatment of pexidartinib therapy
in previously treated participants with tenosynovial giant cell tumor (TGCT).
Phase
Phase 4
Funding Agency/Sponsor
Industrial
Disease
Bone and Soft Tissue Cancers
Enrollment Eligibility
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 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:
- Participant has a clinically significant abnormality identified by the Investigator at
Screening on physical examination, laboratory tests, or electrocardiogram (ECG) which,
in the judgement of the Investigator, would preclude the participant's safe completion
of the study.
- 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.