NL-OMON50338已完成不适用
An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M4344 (formerly VX-803) as a Single Agent and in Combination With Cytotoxic Chemotherapy in Participants With Advanced Solid Tumors - Study of M4344 in Participants With Advanced Solid Tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Merck
- 入组人数
- 16
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 who meet all of the following inclusion criteria will be eligible for
- •this study:
- •1. Male and female subjects *18 years of age
- •2. Disease status:
- •Part A2 and A3: Subjects with histologically or cytologically confirmed
- •malignant advanced solid
- •tumors for which no standard therapy is available which may convey
- •clinical benefit.
- •Part B: Subjects with 1 histologically or cytologically confirmed
- •malignant advanced solid tumors for which no standard therapy is
- •available which may convey clinical benefit, and/or subjects must have
- •progressed after at least 1 prior chemotherapy regimen in the metastatic
- •setting, and for which carboplatin would be considered standard of care.
- •Part C1, C2, and C3: Participants with 1 histologically or cytologically
- •confirmed malignant advanced solid tumors for which no recommended standard
- •therapy is available (i.e. participants who have exhausted all standard of care
- •options according to NCCN Guidance) which may convey clinical benefit, and
- •whose tumor has at least 1 of the following biomarkers as determined by a
- •central trial assay or by an assay with appropriate regulatory status:
- •- C1 or C4: loss-of-function mutations in the gene ARID1A
- •- C2 or C5: loss-of-function mutations in the genes ATRX and/or DAXX
- •- C3 or C6: loss-of-function mutations in the gene ATM
- •3. Measurable disease according to RECIST criteria (Version 1.1)
- •4. WHO performance status of 0 or 1
- •5. Life expectancy of *12 weeks
- •6. Hematological and biochemical indices within the ranges shown below at
- •These values must be confirmed at the first day of dosing, before study drug
- •administration:
- •a. Hemoglobin: *9.0 g/dL for Parts A and B; *8.0 g/dL and no blood transfusions
- •the preceding 28 days for Part C
- •b. Absolute neutrophil count: *2.0 x 109/L
- •c. Platelet count: *125 x 109/L.
- •d. Serum bilirubin: *1.5 x upper limit of normal (ULN), except in the case of
- •or suspected Gilbert*s syndrome.
- •e. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and
- •phosphatase (liver origin): *2.5 x ULN or *5 x ULN in presence of liver
- •f. Serum albimin *2.5g/dL
- •g. Estimated glomerular filtration rate: *50 mL/min for Parts A and B; *40
- •for Parts C
- •h. Prothrombin time: <1.25 x ULN
- •i. In addition, there should not be other clinically significant metabolic or
- •hematologic abnormalities that are uncorrectable or that require ongoing,
- •recurrent pharmacologic management.
- •7. Sign and date an informed consent document
- •8. Willing and able to comply with scheduled visits, treatment plan, lifestyle,
- •tests, contraceptive guidelines, and other study procedures
排除标准
- •Subjects who meet any of the following exclusion criteria are not eligible for
- •this study:
- •1. Radiotherapy, unless brief course for palliative therapy, endocrine therapy,
- •immunotherapy, or chemotherapy during the 4 weeks (6 weeks for nitrosoureas and
- •Mitomycin-C, and 4 weeks for investigational medicinal products) or 4 drug
- •half-lives
- •before first dose of study drug, whichever is greater
- •2. Part B1: More than 6 cycles of prior therapy with carboplatin, unless
- •discussed with and
- •approved by the Merck medical monitor.
- •3. Ongoing toxic manifestations of previous treatments. Exceptions to this are
- •alopecia or
- •certain Grade 1 toxicities, which in the opinion of the investigator should not
- •exclude the
- •Part B1. Any known history of Grade 4 thrombocytopenia with any prior
- •chemotherapy regimen (not applicable for Parts C)
- •4. Brain metastases unless asymptomatic, treated, stable, and not
- •requiring steroids for at least 4 weeks before first dose of study drug
- •5. Female subjects who are already pregnant or lactating, or plan to become
- •pregnant within
- •6 months of the last dose of study drug are excluded. Female subjects of
- •childbearing
- •potential must adhere to contraception guidelines as outlined in Section
- •11.7.5.1. Female
- •subjects will be considered to be of nonchildbearing potential if they have
- •surgical hysterectomy or bilateral oophorectomy or have been amenorrheic for
- •2 years with a screening serum follicle-stimulating hormone (FSH) level within
- •laboratory*s reference range for postmenopausal females.
- •6. Male subjects with partners of childbearing potential must agree to adhere to
- •contraception guidelines in Section 11.7.5.1. Men with pregnant or lactating
- •partners or
- •partners who plan to become pregnant during the study or within 6 months of the
- •dose of study drug are excluded.
- •7. Major surgery *4 weeks before first dose of study drug or incomplete
- •recovery from a
- •prior major surgical procedure
- •8. Cardiac conditions as follows:
- •a. Clinically significant cardiovascular event within 6 months before study
- •i. congestive heart failure requiring therapy
- •ii. unstable angina pectoris
- •iii. myocardial infarction
- •iv. Class II/III/IV cardiac disease (New York Heart Association)
- •v. presence of severe valvular heart disease
- •vi. presence of a ventricular arrhythmia requiring treatment
- •b. History of arrhythmia that is symptomatic or requires treatment
- •(CTCAE Grade 2), symptomatic or uncontrolled atrial fibrillation despite
- •treatment, or asymptomatic sustained ventricular tachycardia. Subjects with
- •atrial fibrillation controlled by medication are permitted.
- •c. Uncontrolled hypertension (blood pressure *160/100 despite optimal therapy)
- •d. Second or third degree heart block with or without symptoms
- 另有 10 项未显示
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