A Phase 1b Study to Assess the Safety and Anti-tumour Activity of Dexanabinol Monotherapy and Dexanabinol in Combination With Chemotherapy in Patients With Advanced Tumours
试验速览
- 阶段
- 1 期
- 入组人数
- 112
- 试验地点
- 13
- 主要终点
- Number of adverse events (AEs) in patients receiving dexanabinol monotherapy
研究概览
简要总结
This study is a trial of dexanabinol in patients with advanced tumours. The purposes of the protocol are to study different doses of the study drug to determine the maximum safe dose of the drug given in combination with standard chemotherapies and to further understand the safety of the study drug and to measure any reduction in size of patients' cancer tumour(s).
Dexanabinol is a synthetic cannabinoid which has previously undergone clinical trials for traumatic brain injury (TBI) and in subjects undergoing coronary artery bypass surgery. Currently dexanabinol is under investigation for potential anti-tumour activity in patients with advanced tumours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
Relapsed or refractory advanced tumours
Patients with selected relapsed or refractory tumour types to receive single agent dexanabinol.
干预措施: Dexanabinol (Drug)
Newly diagnosed hepatocellular carcinoma
Patients with hepatocellular carcinoma to receive dexanabinol in combination with standard chemotherapy.
干预措施: Dexanabinol (Drug)
Newly diagnosed hepatocellular carcinoma
Patients with hepatocellular carcinoma to receive dexanabinol in combination with standard chemotherapy.
干预措施: Sorafenib (Drug)
Newly diagnosed pancreatic cancer
Patients with pancreatic cancer to receive dexanabinol in combination with standard chemotherapy
干预措施: Dexanabinol (Drug)
Newly diagnosed pancreatic cancer
Patients with pancreatic cancer to receive dexanabinol in combination with standard chemotherapy
干预措施: Nab-paclitaxel (Drug)
Newly diagnosed pancreatic cancer
Patients with pancreatic cancer to receive dexanabinol in combination with standard chemotherapy
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Number of adverse events (AEs) in patients receiving dexanabinol monotherapy
时间窗: From start of dosing until 30 days ± 3 days post last dose of dexanbinol
AEs will be graded according to the NCI CTCAE v4.03 for cancer clinical trials.
Maximum Tolerated Dose (MTD) of dexanabinol given in combination with standard chemotherapies
时间窗: For 29 days from the day of first dose
Patients will be sequentially assigned to increasing doses of dexanabinol to establish the MTD (or maximum administered dose (MAD)). 3 patients will be enrolled to a cohort to assess each dose level. Dose escalation to a cohort of 3 new patients will occur when all patients in the previous cohort have completed the first cycle i.e. the first four doses followed by observation through to day 29 and no dose limiting toxicity (DLT) has occurred.
Number of adverse events (AEs) in patients receiving dexanabinol in combination with standard chemotherapies
时间窗: From start of dosing until 30 days ± 3 days post last dose of IMP
AEs will be graded according to the NCI CTCAE v4.03 for cancer clinical trials.
次要结局
- Minimum concentration (Cmin) of dexanabinol and (where applicable) combination chemotherapy(Cycle 1 Day 1 and Day 8 pre-dose (0h); 1, 2, 3h (i.e. immediately prior to end infusion) post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24h post-end infusion day 15 immediately prior to and at end of IMP infusion)
- Area under curve (AUC) of dexanabinol and (where applicable) combination chemotherapy(Cycle 1 Day 1 and Day 8 pre-dose (0h); 1, 2, 3h (i.e. immediately prior to end infusion) post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24h post-end infusion; day 15 immediately prior to and at end of IMP infusion)
- Maximum concentration (Cmax) of dexanabinol and (where applicable) combination chemotherapy(Cycle 1 Day 1 and Day 8 pre-dose (0h); 1, 2, 3h (i.e. immediately prior to end infusion) post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24h post-end infusion day 15 immediately prior to and at end of IMP infusion)
- Tumour response ( RECIST 1.1, assessment by CT or MRI)(Participants will be followed until objective disease progression as per the RECIST v1.1 criteria, an expected average of four months)