NCT01897038已完成1 期
A Phase Ib, Open-Label Study Evaluating The Safety, Tolerability, and Pharmacokinetics of Onartuzumab Given as a Single Agent and in Combination With Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 主要终点
- Number of Participants with Dose-limiting Toxicities (DLT)
研究概览
简要总结
This multicenter, open-label study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities of onartuzumab as single agent or in combination with sorafenib in participants with advanced hepatocellular carcinoma. Participants in Cohort 1 will receive onartuzumab as single agent on Day 1 of each 21-day cycle. Participants in Cohorts 2 or 3 will receive onartuzumab on Day 1 of each 21-day cycle in combination with sorafenib 400 mg orally daily or twice daily. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Cytologically or histologically confirmed diagnosis of hepatocellular carcinoma (HCC)
- •Advanced or metastatic disease
- •Not a candidate for curative treatments (that is, resection, transplantation)
- •Child-Pugh class A liver function
- •Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- •Life expectancy greater than (>) 3 months
- •For participants who received prior adjuvant chemotherapy, a treatment-free interval of at least 6 months between the last chemotherapy cycle and Cycle 1 Day 1
排除标准
- •Prior surgery or local therapy within 4 weeks prior to Cycle 1 Day 1, with the exception of palliative radiation therapy to the bone
- •Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation
- •Granulocyte count less than (<) 1500 per cubic millimeter (mm^3), platelet count < 75,000/mm^3, and hemoglobin < 8 gram per deciliter (g/dL) within 7 days prior to Cycle 1 Day 1
- •Total bilirubin greater than (>) 1.5 times the upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT), Alanine transaminase (ALT) serum glutamic-pyruvic transaminase (SGPT), alkaline phosphatase (ALP) > 5 × ULN
- •Serum creatinine > 1.5 × ULN or creatinine clearance < 60 cubic centimeter per minute (cc/min) by Cockcroft-Gault formula
- •Significant history of cardiac disease within 6 months prior to Cycle 1 Day 1, myocardial infarction within the previous year, or current cardiac ventricular arrhythmias requiring medication
- •Serious active infection, or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment, with the exception of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections
- •Known active infection with human immunodeficiency virus (HIV) or known HIV-seropositivity
- •Inability to take oral medication or untreated malabsorption syndrome
- •Pregnant or lactating women
- •History of transplantation including organ, bone marrow transplantation, and peripheral blood stem cell transplantation with the exception of corneal transplantation
- •Active bleeding diathesis (including active esophageal varices) or tumor rupture within 8 weeks prior to Cycle 1 Day1 that are not successfully treated
- •Uncontrolled hypertension
- •Treatment with any other investigational drug within 4 weeks of Cycle 1 Day
研究组 & 干预措施
Cohort 1 (Onartuzumab)
Experimental
干预措施: Onartuzumab (Drug)
Cohorts 2/3 (Onartuzumab + Sorafenib)
Experimental
干预措施: Onartuzumab (Drug)
Cohorts 2/3 (Onartuzumab + Sorafenib)
Experimental
干预措施: Sorafenib (Drug)
结局指标
主要结局
Number of Participants with Dose-limiting Toxicities (DLT)
时间窗: Maximum up to 42 days
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
时间窗: Up to approximately 31 months
次要结局
- Area Under the Concentration-time Curve (AUC) of Onartuzumab(Day 1 up to Day 15 of Cycle 1, Day 1 of Cycle 2, 3, 4, and every fourth cycle thereafter (maximum up to 31 months))
- Steady-state Plasma Concentrations of Sorafenib When Administered in Combination With Onartuzumab(Day 1 Cycles 1-2)
- Progression-free Survival (PFS)(Up to approximately 31 months)
- Percentage of Participants With Objective Response(Up to approximately 31 months)
- Duration of Response (DR)(Up to approximately 31 months)
- Overall Survival (OS)(Up to approximately 31 months)
- Percentage of Participants With Progression-free Survival at 4 Months (PFS4)(4 months)
- Number of Participants With Anti-therapeutic Antibodies (ATAs) Against Onartuzumab(Up to approximately 31 months)
研究者
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