NL-OMON55479已完成不适用
AN OPEN-LABEL, SINGLE SEQUENCE, CROSSOVER DRUG-DRUG INTERACTION STUDY ASSESSING THE EFFECT OF PEXIDARTINIB ON THE PHARMACOKINETICS OF CYP3A4 AND CYP2C9 SUBSTRATES IN PATIENTS - PL3397-A-U126
Daiichi Pharmaceutical0 个研究点目标入组 3 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
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
- •1.Age * 18 y or * the legal age for being considered as an adult in the country
- •where the patient is screened at the time of signing informed consent.
- •2.DA histopathologically diagnosed tumor as follows: a.DTenosynovial giant cell
- •tumor (TGCT), which is associated with severe morbidity or functional
- •limitations and for whom surgery is not an option. Prior pexidartinib is
- •permitted for TGCT patients unless ineffective or not tolerated and there has
- •been a washout period of at least 4 weeks.
- •b.DKIT-mutant tumor, including melanoma or gastrointestinal stromal tumor
- •(GIST), for which there is no standard systemic therapy.
- •c.DOther solid tumors (all comers) for which there is no standard systemic
- •therapy and there is a rationale for use of pexidartinib at the Investigator's
- •discretion.
- •3.DWomen of childbearing potential must have a negative serum pregnancy test
- •within 14 d prior to enrollment. (Where demanded by local regulations, this
- •test may be required within 72 h prior to enrollment).
- •4.DMen and women of childbearing potential are permitted in the study as long
- •as they consent to avoid getting their partner pregnant or becoming pregnant,
- •respectively, by using a highly effective contraception method, as described
- •below, throughout the study and up to 90 d after completion. Highly effective
- •methods of contraception include intra-uterine device (nonhormonal or
- •hormonal); bilateral tubal occlusion; vasectomy; sexual abstinence (only if
- •this is in line with the patient's current lifestyle); or barrier methods (eg,
- •condom, diaphragm) used in combination with hormonal methods associated with
- •inhibition of ovulation. Women of nonchildbearing potential may be included if
- •they are either surgically sterile or have been postmenopausal for * 1 y. Women
- •who have documentation of at least 12 mo of spontaneous amenorrhea and have a
- •follicle stimulating hormone level > 40 mIU/mL will be considered
- •postmenopausal. The cut-off for performing a follicle- stimulating hormone test
- •is * 50 years old.
- •5.DAdequate hematologic, hepatic, and renal function, defined by:
- •*DAbsolute neutrophil count * 1.5 × 109/L.
- •*DHemoglobin > 10 g/dL.
- •*DPlatelet count * 100 × 109/L.
- •*DAspartate aminotransferase (AST) and alanine aminotransferase
- •(ALT) * upper limit of normal (ULN).
- •*DTotal bilirubin (TBil) and direct bilirubin (DBil) * ULN with an exception of
- •patients with confirmed Gilbert's syndrome. For patients with confirmed
- •Gilbert's syndrome, the total bilirubin should be * 1.5 × ULN.
- •*DSerum creatinine * 1.5 × ULN.
- •6.DWillingness and ability to use a paper pill diary.
- •7.DWillingness and ability to provide written informed consent prior to any
- •study-related procedures and to comply with all study requirements.
排除标准
- •1.Known active or chronic human immunodeficiency virus (HIV) or hepatitis C
- •virus (HCV) infection, or positive hepatitis B (HepB) surface antigen. Prior
- •hepatitis infection that has been treated with highly effective therapy with no
- •evidence of residual infection and with normal liver function (ALT, AST, total
- •and direct bilirubin * ULN) is allowed.
- •2.DKnown active tuberculosis.
- •3.DHepatobiliary diseases including biliary tract diseases, autoimmune
- •hepatitis, inflammation, fibrosis, cirrhosis of liver caused by viral, alcohol,
- •or genetic reasons. Gilbert's disease is allowed if TBil is * 1.5 × ULN.
- •4.Women who are breastfeeding.
- •5.Patients with poor metabolizer status of cytochrome P450 (CYP)
- •6.Patients on potent CYP2C9, CYP3A4, and uridine 5' diphospho-
- •glucuronosyltransferase (UDGT) family 1 member A4 (UGT1A4) inducer and
- •inhibitors and potent P glycoprotein (P-gp) inhibitors and inducers, unless
- •these medications are discontinued at least 14 d before study drug
- •administration. Foods or beverages containing CYP3A4/5 inhibitors (eg,
- •grapefruit, pomegranate, pomelo, and star fruit) should be avoided throughout
- •7.Anti-tumor or investigational agent therapy within 4 weeks prior to
- •8.A screening Fridericia-corrected QT (QTcF) interval * 450 ms (men)
- •or * 470 ms (women).
- •9.History of hypersensitivity to any investigational products, including their
- •excipients.
- •10.Inability to swallow oral medication.
- •11.Inability to complete study procedures.
- •12.Patients on tolbutamide or midazolam and unable to change to alternate
- •therapy. Prior therapy with tolbutamide or midazolam is allowed with a washout
- •period of at least 4 wk.
- •13.Patients with contraindications for tolbutamide or midazolam
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