NL-OMON52692已完成4 期
A Phase 4, Multicenter Study to Evaluate Discontinuation and Re-Treatment in Subjects with Tenosynovial Giant Cell Tumor (TGCT) Previously Treated with Pexidartinib - PL3397-A-U4003
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
排除标准
- •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.
研究者
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