jRCT2080223638已完成2 期
An Open-Label, Phase 2, Parallel Arm Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 Single Agent in Patients with Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Open-Label, Parallel Arm Study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •1.Adult male or female participants aged >=20 years (Japan) or >=18 years (United States).
- •2.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •3.Has pathologically confirmed metastatic pancreatic adenocarcinoma that has progressed after, at least, a first line of standard systemic chemotherapy for the metastatic disease, OR participants with pathologically confirmed metastatic adenocarcinoma of the colon or rectum who have progressed to at least 2 lines of standard systemic chemotherapy for the metastatic disease, OR participants with pathologically confirmed locally advanced or metastatic sqEC that has progressed after at least a first line of standard systemic therapy for metastatic disease. First-line participants can be enrolled if a platinum doublet is contraindicated or refused by the participants, OR pathologically confirmed locally advanced or metastatic sqNSCLC that has progressed after at least 2 lines of standard systemic therapy for metastatic disease.
- •4.For the Western safety cohort only: participants with locally advanced or metastatic solid tumor for whom no standard treatment with an established survival benefit is available or if the participant refuses other standard therapy.
- •5.For disease-specific cohort participants: measurable disease per RECIST V1.1
- •6.Left ventricular ejection fraction >50% as measured by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan within 4 weeks before receiving the first dose of study drug.
- •7.Recovered to Grade 1 or baseline from all toxic effects of previous therapy (except alopecia or neuropathy).
- •8.Suitable venous access for the study-required blood sampling.
- •9.For the Western safety cohort only: willingness to undergo serial skin tissue biopsies.
- •10.For disease-specific cohort participants: Must have an archival (banked) tumor sample or agree to have a new (fresh) tumor biopsy during the screening period. If a new tumor sample is needed, the disease should be accessible for a nonsignificant risk biopsy procedure (those occurring outside the brain, lung/mediastinum, and pancreas, or obtained with endoscopic procedures not extending beyond the stomach or bowel). For participants in the Western safety cohort, this biopsy is optional.
排除标准
- •1.Participants who require continuous use of proton pump inhibitors (PPIs) or histamine-2 (H2) receptor antagonists and participants who are taking PPIs within 5 days before the first dose of study drug.
- •2.Treatment with clinically significant enzyme inducers, such as phenytoin, carbamazepine, phenobarbital, rifampin, rifabutin, rifapentine, or Saint John's wort within 14 days before the first dose of study drug.
- •3.Treatment with any systemic anticancer treatment (including investigational products) within 30 days or 5 half-lives, whichever is shorter, before the first dose of study drug.
- •4.History of any of the following within the last 3 months before administration of the first dose of study drug:
- •Ischemic myocardial event including angina requiring therapy and artery revascularization procedures, myocardial infarction, and unstable symptomatic ischemic heart disease.
- •Ischemic cerebrovascular event, including transient ischemic attack and artery, revascularization procedures.
- •Significant, uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, or ventricular tachycardia).
- •New York Heart Association Class III to IV heart failure.
- •Any other cardiac condition that, in the opinion of the investigator, could pose an additional risk for participation in the study (e.g., pericardial effusion or restrictive cardiomyopathy).
- •Baseline prolongation of the QT interval corrected for heart rate (HR) using Fridericia's formula (QT interval corrected for heart rate using Fridericia's formula (QTcF); e.g., repeated demonstration of QTcF interval >480 millisecond (ms), history of congenital long QT syndrome, or torsades de pointes).
- •5.Hypertension that is unstable or not controlled by medication.
- •6.History of uncontrolled brain metastasis unless:
- •Previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery, and
- •Stable disease (SD) for >=30 days, without steroid use (or stable steroid dose established for >=14 days before the first dose of TAK-931).
- •7.Known history of human immunodeficiency virus infection.
- •8.Known hepatitis B virus (HBV) surface antigen seropositive or detectable hepatitis C virus (HCV) infection viral load. Note: Participants who have positive HBV core antibody or HBV surface antigen antibody can be enrolled but must have an undetectable HBV viral load.
- •9.Prior treatment with radiation therapy involving >=25% of the hematopoietically active bone marrow within 3 months before the first dose of study drug.
- •10.Participants with known microsatellite instability-high (MSI-H) genotype or known wild type tumor protein 53 (TP53) per local testing.
- •11.Western Safety Cohort Only: Participants with Japanese heredity.
研究者
研究点 (1)
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