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INTERVENTIONALCOMPLETEDNCT01812616
A Two Part Study to Assess the Tolerability, Safety and Pharmacodynamics of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent Glioblastoma
An open-label phase to assess the frequency and severity of adverse events in recurrent glioblastoma patients receiving Sativex in combination with dose-intense Temozolomide (Part A). A randomisation phase to assess the safety of Sativex compared with placebo (Part B). Part B will be reported here.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.gov↗last source update 2022-12-20
What this record can show
Protocol only - no registry results posted
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Study at a glance
- Phase
- PHASE1, PHASE2
- Enrollment
- 21 (ACTUAL)
- Start date
- 2014-09
- Sponsor
- Jazz Pharmaceuticals
- Design
- RANDOMIZED · PARALLEL · TREATMENT
- Locations
- 11
- Results record
- Not present in registry snapshot
Patients will receive Sativex and dose-intense Temozolomide in an open-label phase. The incidence of adverse events will be monitored (Part A). An investigator led Safety Review Team will assess the safety profile of the open-label patients and decide whether the study can progress to the randomisation phase (Part B). Patients who enrol in the randomisation phase patients will receive either Sativex or placebo. The safety of Sativex compared to placebo will be assessed by pharmacokinetic analysis of Temozolomide and its metabolites, clinical laboratory tests, adverse events and vital signs.
CancerCancerSafety
Linked local records
Related local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Conditions
No published condition report matched.
Cannabinoids and active compounds
Research network
Researchers and organizations
Interventions
What was registered
DRUGSativex
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).
THC/CBD spray · Nabiximols · GW-1000-02DRUGPlacebo
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 ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and Food, Drugs \& Cosmetics (FD\&C)certified color additives; FD\&C Yellow No.5 (E102 tartrazine) (0.0260%), FD\&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD\&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD\&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%).
Placebo comparator Eligibility
Population and criteria
- Sex
- ALL
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Healthy volunteers
- Not accepted
Inclusion criteria
- Patient is willing and able to give informed consent for participation in the study.
- Patient is aged 18 years or above.
- Histopathologically confirmed diagnosis of grade four Glioblastoma Multiforme as per World Health Organisation classification.
- Evidence of patients first tumour progression (as determined by Revised Assessment in Neuro-Oncology) following radiation and first line chemotherapy with Temozolomide.
- If taking steroids, then the dose must be stable or decreasing.
- Karnofsky performance scale of 60% or greater.
- Patient is able (in the investigators opinion) and willing to comply with all study requirements.
- Patient is willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable in individual countries.
- Patient is willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion criteria
- Patients with Glioblastoma Multiforme secondary to low-grade glioma or anaplastic glioma (anaplastic astrocytoma or anaplastic oligodendroglioma).
- Patients currently receiving treatment for recurrent Glioblastoma Multiforme.
- Less than a four week interval since prior chemotherapy.
- Less than a 12 week interval since prior radiotherapy unless there is either: a) histopathology confirmation of recurrent tumour, or b) new enhancement on Magnetic Resonance Imaging outside of the radiotherapy treatment field.
- Presence of extra-cranial metastatic disease.
- Any surgery, including intracranial biopsy (not including minor diagnostic procedures such as lymph node biopsy) within two weeks of baseline disease assessments; or not fully recovered from any side effects of previous procedures.
- Any history of a different malignancy unless the patient has remained disease-free for at least three years and are at low risk for recurrence of that malignancy (cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin are exempt from this criterion if treatment has occurred).
- Have previously received first line chemotherapy other than Temozolomide.
primary outcomes
primary measures
Incidence of Adverse Events as a Measure of Patient Safety.
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.
secondary outcomes
secondary measures
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 individual treatment groups.
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 in each group from the randomisation phase (Part B) will be presented.
Publications
Locally readable linked articles
linked publicationBritish Journal of Cancer · Free full text Snapshot provenance
- Snapshot
- 4c41092c-aa49-4d10-980b-3fc42116b338
- Retrieved
- 11/09/2026, 14:53:54
- SHA-256
- 25fe297900d93edec670c5f38e0c0f37ab3112c15e4c80e4f38299108a1049ce