NCT01812616

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

Completed Phase 1/Phase 2 Last updated 19 December 2022

What this trial tests

Phase 1/Phase 2 trial testing Sativex in Cancer in 21 participants. Completed in 1 June 2016.

Timeline

1 September 2014

Primary endpoint
1 June 2016

1 June 2016

Quick facts

Lead sponsor	Jazz Pharmaceuticals
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	21
Start date	1 September 2014
Primary completion	1 June 2016
Estimated completion	1 June 2016
Sites	11 locations across Germany, United Kingdom

Drugs / interventions tested

• Sativex — full drug profile →
• Placebo

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

Jazz Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Anticancer mechanisms of cannabinoids.
   Velasco G, Sánchez C, Guzmán M. · · 2016 · cited 161× · PMID 27022311 · DOI 10.3747/co.23.3080
2. Anti-Cancer Potential of Cannabinoids, Terpenes, and Flavonoids Present in Cannabis.
   Tomko AM, Whynot EG, Ellis LD, Dupré DJ. · · 2020 · cited 133× · PMID 32708138 · DOI 10.3390/cancers12071985
3. Cannabinoid Formulations and Delivery Systems: Current and Future Options to Treat Pain.
   Stella B, Baratta F, Della Pepa C, Arpicco S, et al · · 2021 · cited 103× · PMID 34480749 · DOI 10.1007/s40265-021-01579-x
4. The current state and future perspectives of cannabinoids in cancer biology.
   Śledziński P, Zeyland J, Słomski R, Nowak A. · · 2018 · cited 100× · PMID 29473338 · DOI 10.1002/cam4.1312
5. The Endocannabinoid System as a Target in Cancer Diseases: Are We There Yet?
   Moreno E, Cavic M, Krivokuca A, Casadó V, et al · · 2019 · cited 95× · PMID 31024307 · DOI 10.3389/fphar.2019.00339
6. A phase 1b randomised, placebo-controlled trial of nabiximols cannabinoid oromucosal spray with temozolomide in patients with recurrent glioblastoma.
   Twelves C, Sabel M, Checketts D, Miller S, et al · · 2021 · cited 86× · PMID 33623076 · DOI 10.1038/s41416-021-01259-3
7. Cannabinoids in the landscape of cancer.
   Mangal N, Erridge S, Habib N, Sadanandam A, et al · · 2021 · cited 72× · PMID 34259916 · DOI 10.1007/s00432-021-03710-7
8. Cannabigerol Is a Potential Therapeutic Agent in a Novel Combined Therapy for Glioblastoma.
   Lah TT, Novak M, Pena Almidon MA, Marinelli O, et al · · 2021 · cited 58× · PMID 33562819 · DOI 10.3390/cells10020340