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A Two Part Study to Assess the Tolerability, Safety and Pharmacodynamics of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent Glioblastoma

Phase 1/Phase 2
18 Years
Not Enrolling

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Trial Information

A Two Part Study to Assess the Tolerability, Safety and Pharmacodynamics of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent Glioblastoma

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.

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

- 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.

- Presents with Leptomeningeal dissemination.

- Have previously received stereotactic radiotherapy, convection enhanced delivery or
brachytherapy (as gliosis/scarring from these modalities may limit delivery).

- The patient is currently using or has used cannabis or cannabinoid based medications
within 30 days of study entry and is unwilling to abstain for the duration of the

- Any known or suspected history of a substance abuse/dependence disorder, current
heavy alcohol consumption (>60g of pure alcohol per day for men, >40 g of pure
alcohol per day for women), current use of an illicit drug or current non prescribed
use of any prescription drug.

- Any history or immediate family history of schizophrenia, other psychotic illness,
severe personality disorder or other significant psychiatric disorder other than
depression associated with their underlying condition.

- Has experienced myocardial infarction or clinically significant dysfunction within
the last 12 months or has a cardiac disorder that, in the opinion of the investigator
would put the patient at risk of clinically significant arrhythmia or myocardial

- Has grade 3 or above toxicity by Common Terminology Criteria for Adverse Events

- Female patients of child bearing potential and male patients whose partner is of
child bearing potential, unless willing to ensure that they or their partner use
effective contraception, for example, oral contraception, double barrier,
intra-uterine device, during the study and for three months thereafter (however a
male condom should not be used in conjunction with a female condom).

- Female patients who are pregnant, lactating or planning pregnancy during the course
of the study and for three months thereafter.

- Patient who have received an Investigational Medicinal Product within the four weeks
prior to the screening visit.

- Any other significant disease or disorder which, in the opinion of the investigator,
may either put the patient at risk because of participation in the study, or may
influence the result of the study, or the patient's ability to participate in the

- Travel outside the country of residence planned during the study.

- Patients previously enrolled into this study and received either Investigational
Medicinal Product or Dose-Intense Temozolomide.

- Any known or suspected hypersensitivity to cannabinoids or any of the excipients of
the Investigational Medicinal Product.

- Any known allergy to or other intolerability to Temozolomide.

- Following a physical examination, the patient has any abnormalities that, in the
opinion of the investigator would prevent the patient from safe participation in the

- Unwilling to abstain from donation of blood during the study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Incidence of Adverse Events as a Measure of Patient Safety.

Outcome Description:

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.

Outcome Time Frame:

Study Day 1 - Day 358

Safety Issue:


Principal Investigator

Susan Short, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Leeds Institute of Molecular Medicine, St James's University, Leeds.


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

GWCA1208 Part B



Start Date:

August 2013

Completion Date:

September 2015

Related Keywords:

  • Cancer
  • Cancer
  • Safety
  • Glioblastoma