A Study of Dexanabinol in Combination With Chemotherapy in Patients With Advanced Tumours
- Conditions
- Hepatocellular CarcinomaPancreatic Cancer
- Interventions
- Registration Number
- NCT02423239
- Lead Sponsor
- e-Therapeutics PLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 112
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Newly diagnosed hepatocellular carcinoma Sorafenib Patients with hepatocellular carcinoma to receive dexanabinol in combination with standard chemotherapy. Newly diagnosed pancreatic cancer Nab-paclitaxel Patients with pancreatic cancer to receive dexanabinol in combination with standard chemotherapy Newly diagnosed pancreatic cancer Gemcitabine Patients with pancreatic cancer to receive dexanabinol in combination with standard chemotherapy Relapsed or refractory advanced tumours Dexanabinol Patients with selected relapsed or refractory tumour types to receive single agent dexanabinol. Newly diagnosed hepatocellular carcinoma Dexanabinol Patients with hepatocellular carcinoma to receive dexanabinol in combination with standard chemotherapy. Newly diagnosed pancreatic cancer Dexanabinol Patients with pancreatic cancer to receive dexanabinol in combination with standard chemotherapy
- Primary Outcome Measures
Name Time Method Number of adverse events (AEs) in patients receiving dexanabinol monotherapy 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 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 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.
- Secondary Outcome Measures
Name Time Method 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 Tumour response evaluation using RECIST 1.1 (assessment by CT or MRI).
Trial Locations
- Locations (13)
University Hospital Bonn, Study Center Bonn (SZB) Clinical Study Core Unit Institute of Clinical Chemistry and Clinical Pharmacology University Hospital Bonn, Sigmund-Freud-Str. 25
🇩🇪Bonn, Germany
Universitätsklinikum Hamburg-Eppendorf II. Medizinischen Klinik Martinistr. 52
🇩🇪Hamburg, Germany
Klinikum der Ruhr-Universitaet Bochum, Medizinische Klinik III - Hämatologie/Onkologie Marien Hospital Herne Universitätsklinikum der Ruhr-Universität Bochum Hölkeskampring 40
🇩🇪Herne, Germany
Klinikum der Universität München, Universitätsklinikum Großhadern Medizinische Klinik und Poliklinik III AG Onkologie Marchioninistr. 15
🇩🇪München, Germany
UNIFONTIS Praxis fur Integrative Onkologie, Hoppe-Seyler-Straße 6,
🇩🇪Tübingen, Germany
Osrodek Medyczny SAMARYTANIN, ul. Kazimierza Pużaka 11
🇵🇱Opole, Poland
Wojewodzki Szpital Zespolony w Toruniu, ul. Św. Józefa 53-59
🇵🇱Toruń, Poland
Hospital Universitario Virgen de la Victoria, Servicio de Oncología Médica Campus de Teatinos,
🇪🇸Málaga, Malaga, Spain
Freeman Hospital, Sir Bobby Robson Cancer Trials Research Centre, Freeman Road, High Heaton,
🇬🇧Newcastle upon Tyne, United Kingdom
Beatson West of Scotland Cancer Centre, 1053 Great Western Rd,
🇬🇧Glasgow, United Kingdom
St James's Hospital, Cancer Research UK Clinical Centre/Section of Oncology, Beckett St,
🇬🇧Leeds, United Kingdom
START MADRID-FJD, Hospital Fundación Jiménez Díaz, Av Reyes Católicos 2, Floor 1 28040
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocio, Hospital Universitario Virgen del Rocío Oncología Médica Avda. Manuel Siurot,
🇪🇸Sevilla, Spain