A Randomised, Double Blinded, Multicentre Phase II Study to Assess the Efficacy of Olaparib (AZD2281, KU-0059436) in Combination With Paclitaxel Versus Paclitaxel in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) in the Overall Study Population
研究概览
简要总结
To assess the efficacy of olaparib when given in combination with paclitaxel compared with paclitaxel alone as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first-line therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent or metastatic gastric cancer that has progressed following first line-therapy
- •Confirmed ATM protein status by IHC archival tumour sample
- •At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline and follow up visits
排除标准
- •More than one prior chemotherapy regimen for the treatment of gastric cancer in the metastatic or recurrent setting
- •Any previous treatment with a PARP inhibitor, including olaparib
- •Patients with second primary cancer, except; adequately treated non melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for >5 years
研究组 & 干预措施
1
Olaparib + paclitaxel
干预措施: olaparib (Drug)
1
Olaparib + paclitaxel
干预措施: paclitaxel (Drug)
2
paclitaxel + placebo
干预措施: paclitaxel (Drug)
2
paclitaxel + placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Progression Free Survival (PFS) in the Overall Study Population
时间窗: Tumour assessments were carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months
PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.
Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients]
时间窗: Tumour assessments are carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months
PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.
次要结局
- Time to Deterioration in QoL Fatigue Score in the Overall Study Population(Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months)
- Overall Survival (OS) in ATM Negative Patients(Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months)
- Objective Response Rate (ORR) in the Overall Study Population(Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months)
- Objective Response Rate (ORR) in the ATM Negative Patients(Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months)
- Percentage Change in Tumour Size at Week 8 in the Overall Study Population(Tumour scans done at Baseline and week 8)
- Percentage Change in Tumour Size at Week 8 in the ATM Negative Patients(Tumour scans done at Baseline and week 8)
- Overall Survival (OS) in the Overall Study Population(Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months)
- Time to Deterioration in Global Quality of Life (QoL) Score in the Overall Study Population(Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months)
- Time to Deterioration in QoL Nausea & Vomiting Domain Score in the Overall Study Population(Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months)
- Time to Deterioration in QoL Pain Domain Score in the Overall Study Population(Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months)
- Time to Deterioration in QoL Dysphagia Domain Score in the Overall Study Population(Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months)
- Time to Deterioration in QoL Eating Restriction Domain Score in the Overall Study Population(Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months)
- Time to Deterioration in QoL Stomach Pain Domain Score in the Overall Study Population(Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months)
- Time to Deterioration in QoL Reflux Domain Score in the Overall Study Population(Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months)
- Time to Deterioration in QoL Anxiety Domain Score in the Overall Study Population(Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months)