A Safety Study of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent Glioblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01812603|
Recruitment Status : Completed
First Posted : March 18, 2013
Last Update Posted : August 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Sativex||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Two Part Study to Assess the Tolerability, Safety and Pharmacodynamics of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent Glioblastoma|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||June 2016|
Experimental: Sativex and Dose-Intense Temozolomide
Patients will received Sativex and Dose-Intense Temozolomide and in open-label manner
Administered orally as a spray to the cheek according to a standard dose titration regimen, until patients reach a maximum tolerated dose (maximum 12 sprays per day). Each spray delivers 100 μl (Δ9tetrahydrocannabinol (THC), 27 mg/ml: Cannabidiol (CBD), 25 mg/ml).
- The incidence of adverse events in patients receiving Sativex in combination with dose-intense Temozolomide in the open-label phase of the study [ Time Frame: Study Day 1 - Day 358 ]Adverse events will be coded according to the current medical dictionary for regular activities graded using the Common Terminology Criteria for Adverse Events criteria. The number of patients who experienced an adverse event whilst on treatment will be presented.
- The number of patients with Progression Free Survival at six months (PFS6) [ Time Frame: Study Day 1 - Day 190 ]PFS6 will be assessment at Visit 11 (Day 190). Progression of disease will be determined from Response Assessment in Neuro-Oncology tumour assessment (based on Magnetic Resonance Imaging scans). The number of patients with PFS6 will be presented for the open-label phase (Part A).
- Overall Survival [ Time Frame: Study Day 1 - Day 358 ]Overall survival will be assessed at the end of the treatment visit (Day 358 or at early termination). The number of surviving patients from the open-label phase (Part A) will be presented.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812603
|The Clatterbridge Cancer Centre NHS Foundation Trust|
|Bebington, Wirral, United Kingdom, CH63 4JY|
|St James's Institute of Oncology, St James's University Hospital|
|Leeds, Yorkshire, United Kingdom, LS9 7TF|
|Bristol Haematology & Oncology Centre|
|Bristol, United Kingdom, BS2 8ED|
|Guy's and St Thomas NHS Foundation Trust, of St Thomas' Hospital|
|London, United Kingdom, SE1 7EH|
|The Christie NHS Foundation Trust|
|Manchester, United Kingdom, M20 4BX|
|Study Chair:||Susan Short, MD||Leeds Institute of Cancer and Pathology, Wellcome Trust Brenner Buidling, St James Univeristy Hospital, Leeds|
|Principal Investigator:||Christopher Twelves, MD||St James's Institute of Oncology, St James's University Hospital, Leeds.|
|Principal Investigator:||Lucy Brazil, MD||St. Thomas' Hospital, Clinical Oncology, London.|
|Principal Investigator:||Catherine McBain, MD||Dpt. Clinical Oncology, The Christie, Manchester.|
|Principal Investigator:||Brian Haylock, MBBS||The Clatterbridge Cancer Centre, Bebington, Wirral|
|Principal Investigator:||Christopher Herbert, MD||Bristol Haematology & Oncology Centre, Bristol|