EUCTR2013-005100-34-GB进行中（未招募）1 期
An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic / Pharmacodynamic Profile of VX-970 as a Single Agent in Combination With Carboplatin in Subjects With Advanced Solid Tumors
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
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
- •Parts A1, A2, B1 and B2: Subjects with histologically or cytologically confirmed malignant advanced solid tumors refractory to standard therapy or for which no suitable effective standard therapy exists
- •a Parts A1 and A2: Subjects will preferentially have mutations known to be involved in the DDR, e.g., ATM or TP53 genes identified by sequencing of tumor tissue derived DNA, using a platform such as the Illumina MiSeq.
- •b Part B1: In the MTD expansion cohort, at least 6 subjects must have disease sites amenable for paired biopsies
- •Part C: Subjects must have histologically or cytologically confirmed malignant advanced solid tumors or lymphoma and have tumor genotypes and/or phenotypes of interest based on defects in the DDR, the mechanism of action of VX 970, or on data from ongoing clinical studies
- •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 Screening. These values must be confirmed at the first day of dosing, before study drug administration
- •a Hemoglobin: =9.0 g/dL
- •b Absolute neutrophil count: =2.0 × 109/L
- •c Platelet count: =150 × 109/L
- •d Serum bilirubin: =1.5 × upper limit of normal (ULN), unless the subject has known or suspected Gilbert’s syndrome
- •e Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): =2.5 × (ULN) or =5 × ULN in presence of liver metastases
- •f Estimated glomerular filtration rate: =50 mL/min
- •g Prothrombin time: <1.5 × ULN
- •h 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, laboratory tests, contraceptive guidelines, and other study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
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 (except for ongoing luteinizing hormone releasing hormone agonist therapy for subjects with prostate cancer who have progressed), immunotherapy, or chemotherapy during the 4 weeks (6 weeks for nitrosoureas and Mitomycin C, and 4 weeks for IMP) or 4 drug half lives before first dose of study drug, whichever is greater
- •2 Ongoing toxic manifestations of previous treatments including known history of Grade 4 thrombocytopenia with any prior chemotherapy regimen, unless approved by the Vertex Medical Monitor. Exceptions to this are alopecia or certain Grade 1 toxicities, which in the opinion of the investigator should not exclude the subject
- •3 Spinal cord compression or brain metastases unless asymptomatic, treated, stable, and not requiring steroids for at least 4 weeks before first dose of study drug. Any history of leptomeningeal metastases.
- •4 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 11.6.5.1. Female subjects will be considered to be of nonchildbearing potential if they have undergone surgical hysterectomy or bilateral oophorectomy or have been amenorrheic for over 2 years with a screening serum follicle-stimulating hormone level within the laboratory’s reference range for postmenopausal females
- •5 Male subjects with partners of childbearing potential must agree to adhere to contraception guidelines in Section 11.6.5.1. Men with pregnant or lactating partners or partners who plan to become pregnant during the study or within 6 months of the last dose of study drug are excluded
- •6 Major surgery =4 weeks before first dose of study drug, or incomplete recovery from a prior major surgical procedure
- •7 Cardiac conditions as follows:
- •a Clinically significant cardiovascular event within 6 months before study entry:
- •i congestive heart failure requiring therapy
- •ii unstable angina pectoris
- •iii myocardial infarction
- •iv Class II/III/IV cardiac disease
- •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 3), 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
- •e QTc >470 msec not due to electrolyte abnormality and that does not resolve with correction of electrolytes
- •f History of congenital long QT syndrome
- •g History of torsades de pointes (or concurrent medication with a known risk of inducing torsades de pointes)
- •h Clinically-significant abnormality, including ejection fraction below normal institutional limits, present on transthoracic echocar
研究者
相似试验
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 Tumorsadvanced solid tumorsSolid tumors10025319NL-OMON50338Merck16
已完成
2 期
A pilot study in premature infants who are born at less than 29 weeks to determine if surfactant given by aerosol is safe and well-tolerated.Respiratory Distress SyndromeRespiratory - Other respiratory disorders / diseasesACTRN12617001458325CPR Pharma Services30
进行中（未招募）
1 期
An Open-Label Study Of The Safety And Tolerability Of Memantine InPediatric Patients With Autism, Asperger’s Disorder, Or PervasiveDevelopmental Disorder Not Otherwise Specified (PDD-NOS)Autism or Asperger’s Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)MedDRA version: 16.0Level: LLTClassification code 10008520Term: Childhood autismSystem Organ Class: 100000004852MedDRA version: 16.0Level: PTClassification code 10003484Term: Asperger's disorderSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 16.0Level: LLTClassification code 10034739Term: Pervasive developmental disorder NOSSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2012-001616-33-BEForest Research Institute, Inc.900
进行中（未招募）
不适用
An Open-Label Study Of The Safety And Tolerability Of Memantine InPediatric Patients With Autism, Asperger’s Disorder, Or PervasiveDevelopmental Disorder Not Otherwise Specified (PDD-NOS)Autism or Asperger’s Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)MedDRA version: 14.1Level: LLTClassification code 10008520Term: Childhood autismSystem Organ Class: 100000004852MedDRA version: 14.1Level: PTClassification code 10003484Term: Asperger's disorderSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 14.1Level: LLTClassification code 10034739Term: Pervasive developmental disorder NOSSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2012-001616-33-EEForest Research Institute, Inc.900
进行中（未招募）
不适用
An Open-Label Study Of The Safety And Tolerability Of Memantine InPediatric Patients With Autism, Asperger’s Disorder, Or PervasiveDevelopmental Disorder Not Otherwise Specified (PDD-NOS)EUCTR2012-001616-33-ISForest Research Institute, Inc.192