jRCT2080223766已完成1 期
A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-228 (a Catalytic TORC1/2 Inhibitor) as Single Agent in Adult East Asian Patients with Advanced Nonhematological Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Number of Participants with Grade 3 or Higher TEAEs
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, Non-randomized, Parallel Assignment 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
- •With advanced nonhematologic malignancies, with the exception of primary brain tumor, and have failed or are not eligible for standard of care therapy. History of brain metastasis may be allowed if all of the following criteria are met:
- •Brain metastases have been treated.
- •There is no evidence of progression or hemorrhage after treatment.
- •Steroid has been discontinued for >=4 weeks before the first dose of study drug.
- •There is no ongoing requirement for steroids or anti-epileptic drugs.
- •Received not more than 4 prior lines of systemic cytotoxic chemotherapy for advanced or metastatic disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to
- •Screening clinical laboratory values as specified below:
- •Bone marrow reserve consistent with absolute neutrophil count (ANC) >=2000 per cubic millimeter (/mm^3), platelet count >=125,000/mm^3, and hemoglobin >=10 gram per deciliter (g/dL) without transfusion in the last 4 weeks.
- •Note: Prophylactic transfusions of blood products or any prophylactic use of hematopoietic growth factors (such as erythropoietin, thrombopoietin, granulocyte colony stimulating factor [G-CSF], and granulocyte macrophage colony stimulating factor [GM-CSF]) is not permitted during the screening period.
- •Hepatic: Total bilirubin less than or equal to (<=) 1.5*upper limit of normal (ULN), alanine aminotransferase (ALT)/aspartate aminotransferase (AST) <=2.5*ULN (<=5*ULN if their elevation can be reasonably ascribed to the presence of hepatocellular carcinoma, biliary tract cancer, or metastatic disease in liver).
- •Adequate renal function, defined as meeting any 1 of the following criteria:
- •a) Serum creatinine <1.5*ULN.
- •b) Creatinine clearance based on the Cockcroft-Gault estimate >=40 milliliter per minute (mL/min).
- •c) Creatinine clearance based on urine collection (12- or 24-hour) >=40 mL/min.
- •d) Metabolic: Glycosylated hemoglobin (hemoglobin A1c [HbA1c]) <=7%, fasting serum glucose <=130 milligram per deciliter (mg/dL), and fasting triglycerides <=300 mg/dL.
排除标准
- •Diagnosis of primary brain tumor.
- •Untreated brain metastasis or history of leptomeningeal disease or spinal cord compression.
- •Failed to recover from the reversible effects of prior anticancer therapies with the exception of alopecia, and after-effects associated with prior tyrosine kinase inhibitor therapy, such as hair depigmentation, hypothyroidism, and/or splinter hemorrhage.
- •Initiation of hematopoietic growth factors within 1 week before the first dose of study drug.
- •Manifestations of malabsorption caused by prior gastrointestinal surgery, gastrointestinal disease, or for some other reason that may alter the absorption of TAK-
- •In addition, participants with enteric stomata are also excluded.
- •Poorly controlled diabetes mellitus defined as Hemoglobin A1c (HbA1c) greater than (>) 7%; participants with a history of transient glucose intolerance caused by corticosteroid administration are allowed if all other eligibility criteria are met.
- •Known human immunodeficiency virus infection.
- •Known hepatitis B surface antigen (HBsAg) positive, or known or suspected active hepatitis C virus (HCV) infection.
- •Note: Participants who have isolated positive hepatitis B core antibody (HBcAb) and/or hepatitis B surface antibody (HBsAb) (that is, in the setting of negative HBsAg) may be enrolled but must have an undetectable hepatitis B virus (HBV) viral load. Participants who have positive hepatitis C virus antibody (HCVAb) may be enrolled but must have an undetectable HCV viral load.
- •Significant active cardiovascular or pulmonary disease before the first dose of study drug, including:
- •Uncontrolled hypertension (that is, systolic blood pressure >180 millimeter of mercury [mmHg]; diastolic blood pressure >95 mmHg).
- •Pulmonary hypertension.
- •Uncontrolled asthma or oxygen saturation less than (<) 90% by pulse oximetry on room air.
- •Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention; or history of valve replacement.
- •Medically significant (symptomatic) bradycardia.
- •History of arrhythmia requiring an implantable cardiac defibrillator.
- •Baseline prolongation of the rate corrected QT interval (QTc) (example, repeated demonstration of QTc interval >480 millisecond [ms], or history of congenital long QT syndrome, or torsades de pointes).
- •Diagnosed or treated for another malignancy within 2 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
结局指标
主要结局
Number of Participants with Grade 3 or Higher TEAEs
时间窗: Baseline up to 30 days after the last dose of study drug (up to Cycle 12 Day 58) (Cycle length= 28 days)
Adverse Event (AE) Grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 4.03. Grade 1 scaled as Mild; Grade 2 scaled as Moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE.
次要结局
- Clinical Benefit Rate(Baseline up to 1 Year 7 Months)
研究者
研究点 (1)
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