NCT03042611已完成3 期
A Prospective, Randomized, Double-Blinded, Placebo-Controlled, Multinational, Multicenter, Parallel-group, Phase III Study to Evaluate the Efficacy and Safety of Apatinib Plus Best Supportive Care (BSC) Compared to Placebo Plus BSC in Patients With Advanced or Metastatic Gastric Cancer
Elevar Therapeutics95 个研究点 分布在 6 个国家目标入组 460 人开始时间: 2017年3月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 460
- 试验地点
- 95
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of rivoceranib plus best supportive care (BSC) compared to placebo plus BSC in participants with advanced or metastatic gastric cancer (GC).
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
- Triple (Participant, Care Provider, 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
- •Documented primary diagnosis of histologic- or cytologic-confirmed adenocarcinoma of the stomach or gastroesophageal junction.
- •Locally advanced unresectable or metastatic disease that has progressed since last treatment.
- •One or more measurable or nonmeasurable evaluable lesions per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
- •Failure or intolerance to at least 2 prior lines of standard chemotherapies with each containing one or more of the following agents:
- •fluoropyrimidine (intravenous [IV] 5-fluorouracil [5-FU] capecitabine, or S-1),
- •platinum (cisplatin or oxaliplatin),
- •taxanes (paclitaxel or docetaxel) or epirubicin,
- •irinotecan,
- •trastuzumab in case of human epidermal growth factor receptor 2 (HER2)-positive,
- •ramucirumab
- •nivolumab
- •pembrolizumab
- •Disease progression within 6 months after the last treatment.
- •Adequate bone-marrow, renal and liver function.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •Expected survival of ≥12 weeks, in the opinion of the investigator.
排除标准
- •History of another malignancy within 2 years prior to randomization except for the following: Bladder tumors considered superficial such as noninvasive (T1a) and carcinoma in situ (CIS); Curatively treated cervical CIS; Thyroid papillary cancer with prior treatment; Carcinoma of the skin without melanomatous features; Prostate cancer which had been surgically or medically treated and not likely to recur within 2 years.
- •Central nervous system (CNS) metastases as shown by radiology records or clinical evidence of symptomatic CNS involvement in the last 3 months prior to randomization.
- •Cytotoxic chemotherapy, surgery, immunotherapy, radiotherapy or other targeted therapies within 3 weeks (4 weeks in cases of ramucirumab, mitomycin C, nitrosourea, lomustine; 1 week in case of biopsy) prior to randomization (Adjuvant radiotherapy given to local area for non-curative symptom relief is allowed until 2 weeks before randomization.).
- •Therapy with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to randomization that may prevent blood clotting and, in the investigator's opinion, could place the participant at risk.
- •Participants who had therapeutic paracentesis of ascites (>1 Liter [L]) within the 3 months prior to starting study treatment or who, in the opinion of the investigator, will likely need therapeutic paracentesis of ascites (>1L) within 3 months of starting study treatment.
- •Previous treatment with rivoceranib.
- •Known hypersensitivity to rivoceranib or components of the formulation.
- •Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9, and CYP2C19.
研究组 & 干预措施
Rivoceranib Plus BSC
Experimental
Participants will receive rivoceranib 700 milligrams (mg) orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration is 28 days.
干预措施: Rivoceranib (Drug)
Placebo
Experimental
Participants will receive matching placebo to rivoceranib orally once per day during each cycle plus BSC. BSC is defined as palliative, non-cancer therapy. Each cycle duration is 28 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Day 1 (randomization) up to approximately 36 months
OS was defined as the time from randomization to death. Participants alive or lost to follow-up at the end of study (EOS) were censored.
次要结局
- Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)(Up to approximately 24 months)
- Objective Response Rate (ORR) Per RECIST 1.1(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Baseline, End of Treatment (EOT) (Up to 24 months))
- Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Score(Baseline, EOT (Up to 24 months))
- Change From Baseline in EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score(Baseline, EOT (Up to 24 months))
- Number of Participants Per QOL Dimension Response as Measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire(EOT (Month 24))
研究者
研究点 (95)
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