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CancerPhase 1/2NCT01812616

A Safety Study of Sativex Compared With Placebo (Both With Dose-intense Temozolomide) in Recurrent Glioblastoma Patients

A Phase 1/2 study testing Sativex in people with Cancer, run by Jazz Pharmaceuticals at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Sativex
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
11 sitesin 2 countries
Study dates
Sep 2014to Jun 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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 study.
  • 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 infarction.
  • Has grade 3 or above toxicity by Common Terminology Criteria for Adverse Events criteria.
  • 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 study.
  • 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 study.
  • Unwilling to abstain from donation of blood during the study.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

United Kingdom7 sites

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Bebington, Wirral, CH63 4JY

  • Bristol Haematology & Oncology Centre

    Bristol, BS2 8ED

  • Queen's Centre for Haematology & Oncology, Castle Hill Hospital

    Cottingham, HU16 5JQ

  • West of Scotland Beatson Cancer Centre

    Glasgow, G12 0YN

  • St James's Institute of Oncology, St James's University Hospital

    Leeds, Yorkshire, LS9 7TF

  • Guy's & St Thomas' NHS Foundation Trust, of St Thomas' Hospital

    London, SE1 7EH

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

Other trials in United Kingdom

Germany4 sites

  • Klinik für Onkologie, Hämatologie und Stammzelltransplantation, Universitätsklinikum Aachen RWTH

    Aachen, 52074

  • Neurologie des Klinikums Altenburger Land

    Altenburg, 04600

  • Zentrum für Neuroonkologie der Universität Duesseldorf

    Düsseldorf, 40225

  • Strahlenklinik der Universität Erlangen

    Erlangen, 91054

Other trials in Germany

About this study

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

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.

Read the detailed description

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.

Conditions
Cancer
Being tested
Sativex, Placebo
Keywords
Cancer, Safety
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SativexDrug

    Also called THC/CBD spray, Nabiximols, GW-1000-02

    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).

  • PlaceboDrug

    Also called Placebo comparator

    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%).

Study groups in NCT01812616
Study groupRoleWhat they receive
Sativex and Dose-Intense TemozolomideExperimentalPatients will received Sativex and Dose-Intense Temozolomide in a double-blind manner
Receives: Drug: Sativex
Placebo and Dose-Intense TemozolomidePlacebo comparatorPatients will received placebo and Dose-Intense Temozolomide and in double-blind manner
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events as a Measure of Patient Safety.

    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.

    Measured: Study Day 1 - Day 358

Secondary outcomes (2)

  1. The number of patients with Progression Free Survival at six months (PFS6)

    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.

    Measured: Study Day 1 - Day 190

  2. Overall Survival

    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.

    Measured: Study Day 1 - Day 358

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2013 (estimated)
  2. Study startSep 2014
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01812616
Sponsor's protocol ID
GWCA1208 Part B
Status last verified
Dec 2022
First submitted
14 Mar 2013
Last updated
20 Dec 2022
Results posted
No
Data monitoring committee
No

Publications

  • Twelves C, Sabel M, Checketts D, Miller S, Tayo B, Jove M, Brazil L, Short SC; GWCA1208 study group. A phase 1b randomised, placebo-controlled trial of nabiximols cannabinoid oromucosal spray with temozolomide in patients with recurrent glioblastoma. Br J Cancer. 2021 Apr;124(8):1379-1387. doi: 10.1038/s41416-021-01259-3. Epub 2021 Feb 24.

    PubMed 33623076

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sativex in people with Cancer, run by Jazz Pharmaceuticals at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events as a Measure of Patient Safety. (time frame: Study Day 1 - Day 358). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01812616, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.

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