A Phase II Study of RRx-001 in Platinum Refractory/Resistant Small Cell Carcinoma, EGFR TKI Resistant EGFR+ T790M Negative Non-Small Cell Lung Cancer, High Grade Neuroendocrine Tumors and Resistant/Refractory Ovarian Cancer Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 10
- 主要终点
- Overall Survival
研究概览
简要总结
This study is designed to explore the potential of the epigenetic agent RRx-001 to sensitize patients who previously received and now have failed a platinum based doublet regimen. RRx-001 is administered with autologous blood once weekly followed by or in combination with reintroduction of platinum-based doublet therapy.
详细描述
This is an open label, four 'cohort' study for administration of RRx-001 with autologous blood once weekly followed by or in combination with reintroduction of platinum-based doublet therapy according to the treatment schedule listed below. Small cell carcinoma and ovarian cohort participants will be randomized to 1 of 2 treatment arms, respectively. Neuroendocrine and NSCLC patients will be enrolled to single arms.
Participants with SCC will receive one of the following; RRx-001 followed by platinum doublet chemotherapy or platinum based chemotherapy alone. HGNEC, RRx-001 followed by platinum doublet chemotherapy. NSCLC, RRx-001 followed by platinum doublet chemotherapy. Participants with Platinum Refractory/Resistant Ovarian and MMMT will receive one of the following, RRx-001 followed by platinum doublet chemotherapy or chemotherapy alone.
Approximately 213 participants will be enrolled.
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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Small Cell Lung Cancer (Arm 1)
RRx-001 weekly for 3 weeks followed by up to 4 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 and carboplatin or cisplatin (for patients with stable disease (SD) or better at discontinuation of platinum).
干预措施: RRx-001 (Drug)
Small Cell Lung Cancer (Arm 1)
RRx-001 weekly for 3 weeks followed by up to 4 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 and carboplatin or cisplatin (for patients with stable disease (SD) or better at discontinuation of platinum).
干预措施: Cisplatin (Drug)
Small Cell Lung Cancer (Arm 1)
RRx-001 weekly for 3 weeks followed by up to 4 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 and carboplatin or cisplatin (for patients with stable disease (SD) or better at discontinuation of platinum).
干预措施: Etoposide (Drug)
Small Cell Lung Cancer (Arm 1)
RRx-001 weekly for 3 weeks followed by up to 4 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 and carboplatin or cisplatin (for patients with stable disease (SD) or better at discontinuation of platinum).
干预措施: Carboplatin (Drug)
Small Cell Lung Cancer (Arm 2)
Carboplatin or cisplatin plus etoposide or irinotecan or vinorelbine until progression or intolerable toxicity
干预措施: Cisplatin (Drug)
Small Cell Lung Cancer (Arm 2)
Carboplatin or cisplatin plus etoposide or irinotecan or vinorelbine until progression or intolerable toxicity
干预措施: Etoposide (Drug)
Small Cell Lung Cancer (Arm 2)
Carboplatin or cisplatin plus etoposide or irinotecan or vinorelbine until progression or intolerable toxicity
干预措施: Carboplatin (Drug)
Small Cell Lung Cancer (Arm 2)
Carboplatin or cisplatin plus etoposide or irinotecan or vinorelbine until progression or intolerable toxicity
干预措施: Irinotecan (Drug)
Small Cell Lung Cancer (Arm 2)
Carboplatin or cisplatin plus etoposide or irinotecan or vinorelbine until progression or intolerable toxicity
干预措施: Vinorelbine (Drug)
Non Small Cell Lung Cancer
RRx-001 weekly for 3 weeks followed by up to 6 cycles of cisplatin or carboplatin plus paclitaxel or nab-paclitaxel or pemetrexed and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum).
干预措施: RRx-001 (Drug)
Non Small Cell Lung Cancer
RRx-001 weekly for 3 weeks followed by up to 6 cycles of cisplatin or carboplatin plus paclitaxel or nab-paclitaxel or pemetrexed and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum).
干预措施: Cisplatin (Drug)
Non Small Cell Lung Cancer
RRx-001 weekly for 3 weeks followed by up to 6 cycles of cisplatin or carboplatin plus paclitaxel or nab-paclitaxel or pemetrexed and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum).
干预措施: Carboplatin (Drug)
Non Small Cell Lung Cancer
RRx-001 weekly for 3 weeks followed by up to 6 cycles of cisplatin or carboplatin plus paclitaxel or nab-paclitaxel or pemetrexed and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum).
干预措施: Paclitaxel (Drug)
Non Small Cell Lung Cancer
RRx-001 weekly for 3 weeks followed by up to 6 cycles of cisplatin or carboplatin plus paclitaxel or nab-paclitaxel or pemetrexed and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum).
干预措施: Nab-Paclitaxel (Drug)
Non Small Cell Lung Cancer
RRx-001 weekly for 3 weeks followed by up to 6 cycles of cisplatin or carboplatin plus paclitaxel or nab-paclitaxel or pemetrexed and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum).
干预措施: Pemetrexed (Drug)
Neuroendocrine tumors
RRx-001 weekly until progression followed by up to 6 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum).
干预措施: RRx-001 (Drug)
Neuroendocrine tumors
RRx-001 weekly until progression followed by up to 6 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum).
干预措施: Cisplatin (Drug)
Neuroendocrine tumors
RRx-001 weekly until progression followed by up to 6 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum).
干预措施: Etoposide (Drug)
Neuroendocrine tumors
RRx-001 weekly until progression followed by up to 6 cycles of carboplatin or cisplatin plus etoposide and then RRx-001 maintenance (for patients with stable disease or better at discontinuation of platinum).
干预措施: Carboplatin (Drug)
Ovarian epithelial cancer (Arm 1)
RRx-001 weekly for 2 weeks followed by 2 cycles of Carboplatin chemotherapy and then RRx-001/Carboplatin maintenance (for patients with stable disease or better at discontinuation of platinum).
干预措施: RRx-001 (Drug)
Ovarian epithelial cancer (Arm 1)
RRx-001 weekly for 2 weeks followed by 2 cycles of Carboplatin chemotherapy and then RRx-001/Carboplatin maintenance (for patients with stable disease or better at discontinuation of platinum).
干预措施: Carboplatin (Drug)
Ovarian epithelial cancer (Arm 2)
Carboplatin, Etoposide, Doxil, Gemcitabine or Vinorelbine or Taxane until progression or intolerable toxicity
干预措施: Etoposide (Drug)
Ovarian epithelial cancer (Arm 2)
Carboplatin, Etoposide, Doxil, Gemcitabine or Vinorelbine or Taxane until progression or intolerable toxicity
干预措施: Carboplatin (Drug)
Ovarian epithelial cancer (Arm 2)
Carboplatin, Etoposide, Doxil, Gemcitabine or Vinorelbine or Taxane until progression or intolerable toxicity
干预措施: Vinorelbine (Drug)
Ovarian epithelial cancer (Arm 2)
Carboplatin, Etoposide, Doxil, Gemcitabine or Vinorelbine or Taxane until progression or intolerable toxicity
干预措施: Doxil (Drug)
Ovarian epithelial cancer (Arm 2)
Carboplatin, Etoposide, Doxil, Gemcitabine or Vinorelbine or Taxane until progression or intolerable toxicity
干预措施: Gemcitabine (Drug)
Ovarian epithelial cancer (Arm 2)
Carboplatin, Etoposide, Doxil, Gemcitabine or Vinorelbine or Taxane until progression or intolerable toxicity
干预措施: Taxane (Drug)
结局指标
主要结局
Overall Survival
时间窗: From start of treatment through death for up to 64 months from Start of Treatment.
From the time from enrollment until the time of death from any cause or last follow-up. Patients will be followed clinically as outlined in the treatment schedule and will be followed off study for death.
次要结局
- Overall Response Rate (ORR)(Assessed up to 49 months)
- Disease Control Rate (DCR)(Assessed up to 49 months)
- Progression Free Survival (PFS)(Assessed up to 49 months)