NL-OMON46366尚未招募不适用
An open-label, Phase I study to assess the effect of itraconazole (CYP3A4 and P-gp inhibitor) on the pharmacokinetics of anetumab ravtansine and to assess the ECG effects, safety and immunogenicity of anetumab ravtansine given as a single agent and together with itraconazole in subjects with mesothelin-expressing advanced solid cancers. - Anetumab ravtansine drug interaction study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Bayer
- 入组人数
- 8
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 have histologically confirmed, locally advanced or metastatic solid cancers of the following histological types:
- •a.) predominantly epithelial (>=50% tumor component) pleural or peritoneal mesothelioma
- •b.) epithelial ovarian cancer (fallopian tube and primary peritoneal cancers are eligible)
- •c.) adenocarcinoma of the pancreas,
- •d.) triple-negative adenocarcinoma of the breast
- •e.) non-small-cell adenocarcinoma of the lung
- •f.) gastric cancer (including gastro-esophageal junction)
- •g.) colon cancer
- •h.) cholangiocarcinoma
- •i.) Thymic carcinoma;- Subjects must have no standard therapy available, or have actively refused standard therapy or, in the investigator*s opinion, treatment in this study is clinically and ethically acceptable for the subject.;- Subjects must provide samples of archival tumor tissue collected and submitted anytime during the study.
- •- Subjects must have positive mesothelin expression in the archival tumor tissue, defined as the membrane intensity score of 1+, 2+ or 3+ (on the 0-3 scale) expressed on the membrane of >=5% of tumor cells combined.;- Life expectancy of at least 12 weeks.;- ECOG performance status of 0 or 1.;- Subjects must have adequate bone marrow, renal and hepatic function and coagulation;- Subjects must have normal or clinically insignificant ECG at screening.;- Negative pregnancy test if woman of reproductive potential.;- If of reproductive potential, must agree to use adequate contraception as per protocol.
排除标准
- •- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial noninvasive bladder tumors or any previous cancer curatively treated greater than or equal to 3 years before the start of anetumab ravtansine.;- New or progressive brain or meningeal or spinal metastases.;- Poor CYP2D6 metabolizers based on the screening test for CYP2D6 genetic polymorphisms.;- Corneal epitheliopathy or any eye disorder that may predispose the subjects to drug-induced corneal epitheliopathy, or may interfere with diagnosis of treatment-emergent corneal epitheliopathy at the ophthalmologist*s or the investigator*s discretion. ;- History or current evidence of:
- •-- biliary cirrhosis
- •-- malignant biliary obstruction unless the bile flow to the gastrointestinal tract is maintained by a fully operational biliary stent
- •-- CTCAE (Common Terminology Criteria for Adverse Events) Grade >=2 bleeding disorder within 4 weeks before the start of anetumab ravtansine
- •-- uncontrolled cardiovascular disease or uncontrolled hypertension
- •-- Long QT Syndrome
- •-- HIV infection
- •-- Hepatitis B or C infection;- Left ventricular ejection fraction (LVEF) <50% at screening.;- Have QTc >450 ms or heart rate >=100 bpm or <=45 bpm at screening.;- Solid organ or bone marrow transplantation.;- Major surgery or significant trauma within 4 weeks before the start of anetumab ravtansine.
研究者
相似试验
已完成
1 期
A phase 1 open-label study evaluating the effects of food on TAS-205 in healthy volunteersDuchenne Muscular DystrophyJPRN-jRCT2071230028Takeda Shin'ichi20
已完成
1 期
Pharmacokinetics of terguride in healthy subjects with known CYP2D6 genotypeCYP2D6 genotypeGenetic DiseasesISRCTN36145549medac GmbH36
已完成
不适用
Open-label phase I study to investigate the effect of multiple doses of tasquinimod on the single-dose pharmacodynamics and pharmacokinetics of warfarin in healthy subjects1002765610036958prostate cancerNL-OMON35250Active Biotech15
已完成
不适用
A Phase I, Open-Label Study to Determine the Effect of Repeat Dosing of Trametinib on the Pharmacokinetics of a Combined Oral Contraceptive (Norethindrone plus Ethinyl Estradiol) in Female Patients with Solid TumorsSolid tumorsSolid tumors with a BRAF V600 mutation10027655NL-OMON47513ovartis2
进行中（未招募）
不适用
A Phase I/II open label study to assess efficacy and safety of IPH1101 associated with low dose of interleukin 2, as add-on therapy to imatinib in CML patients with residual molecular diseaseEUCTR2007-004252-37-FRInnate Pharma