A Randomized Phase 2 Study of LY2157299 Versus LY2157299 - Sorafenib Combination Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Overall Survival (OS): Number of Events
研究概览
简要总结
The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as LY2157299 in participants with hepatocellular carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Have histological evidence of a diagnosis of HCC not amenable to curative surgery.
- •Have Child-Pugh Class A.
- •Have the presence of measurable disease.
- •Have adequate organ function.
- •Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
- •If male or female with reproductive potential, must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug.
- •If females with childbearing potential, must have had a negative serum pregnancy test 7 days prior to the first dose of study drug.
- •Are able to swallow capsules or tablets.
- •Have available diagnostic or biopsy tumor tissue.
排除标准
- •Have received previous systemic treatment for advanced disease.
- •Have known HCC with fibro-lamellar or mixed histology.
- •Have presence of clinically relevant ascites.
- •Have had a liver transplant.
- •Have moderate or severe cardiac disease.
- •Have active or uncontrolled clinically serious hepatitis B virus or hepatitis C virus infection.
- •Have experienced Grade 3 or 4 gastrointestinal bleeding or any variceal bleeding episode in the 3 months prior to enrollment requiring transfusion or endoscopic or operative intervention.
- •Have esophageal or gastric varices that require immediate intervention or represent a high bleeding risk.
- •Had major surgery within 4 weeks prior to the study randomization.
研究组 & 干预措施
150 milligram (mg) Galunisertib Monotherapy
150 mg galunisertib administered orally, twice daily (BID) for 14 days followed by 14 days with no study drug (28 days cycle).
干预措施: LY2157299 (Drug)
150 mg Galunisertib + 400 mg Sorafenib Therapy
150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).
400 mg sorafenib administered orally BID for 28 days.
干预措施: LY2157299 (Drug)
150 mg Galunisertib + 400 mg Sorafenib Therapy
150 mg galunisertib administered orally, BID for 14 days followed by 14 days with no study drug (28 days cycle).
400 mg sorafenib administered orally BID for 28 days.
干预措施: Sorafenib (Drug)
400 mg Sorafenib + Placebo Therapy
Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle).
400 mg sorafenib administered orally BID for 28 days.
干预措施: Sorafenib (Drug)
400 mg Sorafenib + Placebo Therapy
Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 days cycle).
400 mg sorafenib administered orally BID for 28 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival (OS): Number of Events
时间窗: Randomization to Date of Death from Any Cause (Up To 24 Months)
OS defined as the time from the date of randomization to the date of death due to any cause. An overall survival event was defined as death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. The number of participants with overall survival events (deaths) is reported.
次要结局
- Progression-Free Survival (PFS)(Randomization to Measured Progressive Disease or Death (Up To 24 Months))
- Population Pharmacokinetics (PopPK): Steady State Apparent Volume of Distribution (Vss) of Galunisertib(Cycle (C) 1: Day (D)1: Predose, 0.5-2 hours(h) Postdose; D14: Predose, 0.5-2, 3-5 h, Postdose; D15 Morning; D22 Morning; Predose C2 and C3 Predose D1)
- Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])(Randomization to Measured Progressive Disease (Up To 24 Months))
- Population Pharmacokinetics (PopPK): Mean Population Clearance of Galunisertib(Cycle (C) 1: Day (D)1: Predose, 0.5-2 hours(h) Postdose; D14: Predose, 0.5-2, 3-5 h, Postdose; D15 Morning; D22 Morning; Predose C2 and C3 Predose D1)
- Time to Tumor Progression (TTP)(Randomization to the Date of Objective Progressive Disease or Date of Death due to Study Disease, whichever came first (Up To 24 Months))
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Score(Baseline, 24 Months)
- Change From Baseline in EORTC QLQ Hepatocellular Carcinoma (HCC-18) Questionnaire Score(Baseline, 24 Months)