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Brief Title: A Study of Dexanabinol in Combination With Chemotherapy in Patients With Advanced Tumours
Official Title: 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
Study ID: NCT02423239
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
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
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
Freeman Hospital, Sir Bobby Robson Cancer Trials Research Centre, Freeman Road, High Heaton,, Newcastle upon Tyne, , United Kingdom