A Phase 4, Multicenter Study to Evaluate Discontinuation and Re-Treatment in Subjects with Tenosynovial Giant Cell Tumor (TGCT) Previously Treated with Pexidartinib
- Conditions
- Pigmented Villonodular Synovitis (PVNS)Tenosynovial giant cell tumor (TGCT)10072990
- Registration Number
- NL-OMON52692
- Lead Sponsor
- DAIICHI SANKYO, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
Subjects must meet all of the following criteria to be eligible for
enrollment into the study:
1. Currently enrolled and have not been discontinued from pexidartinib
treatment in one of the following studies: Study PLX108-10 (ENLIVEN),
Study PLX108-01, Study PL3397-A-A103, or Study PL3397-A-U126.
2. Willing and able to complete the PROMIS (Physical Function Scale)
and EQ-5D-5L (European Quality of Life) throughout the study.
3. Willing and able to provide written informed consent form (ICF) prior
to any study-related procedures and to comply with all study
requirements.
4. 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 End-of-Treatment visit of their prior study)
and should be 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 potentialshould 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.
5. Male subjects 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 subjects 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.
Subjects who meet any of the following criteria are NOT eligible for
enrollment into the study
1. Subject has a clinically significant abnormality identified by the
Investigator at Screening on physical examination, laboratory tests, or
electrocardiogram which, in the judgement of the Investigator, would
preclude the subject's safe completion of the study.
2. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Proportion of subjects who remain treatment-free at Month 12 and Month 24</p><br>
- Secondary Outcome Measures
Name Time Method <p>Change from Baseline in Patient Reported Outcomes (PROs): Mean<br /><br>change from Baseline* for PROMIS PF and EQ-5D-5L quarterly for the<br /><br>treatment-free and Re-Treatment periods.<br /><br>*Note: Baseline is Screening values for Treatment Free Period<br /><br>Treatment Continuation Cohort. Baseline is reinitiated with subject<br /><br>entering Re-Treatment period.<br /><br>Safety: Incidence of AEs/TEAEs and SAEs, ECGs, and laboratory<br /><br>assessments<br /><br>Tumor Assessment: Qualitative assessment of the tumor (not applicable<br /><br>to Treatment-Free period)</p><br>