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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

4155 - Pilot and definitive randomised double-blind placebo-controlled trials evaluating an oral cannabinoid-rich THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting (CINV)

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Presenters

Antony Mersiades

Citation

Annals of Oncology (2018) 29 (suppl_8): viii603-viii640. 10.1093/annonc/mdy300

Authors

A. Mersiades1, A. Tognela2, P.S. Haber3, M. Stockler1, N. Lintzeris3, J. Simes1, I. McGregor4, I. Olver5, D.J. Allsop4, C. Gedye6, A. Kirby1, R.L. Morton1, K. Briscoe7, P. Fox8, M. Aghmesheh9, N. Wong1, A. Bhardwaj1, A.D. Tran1, C. Hahn10, P. Grimison10

Author affiliations

  • 1 Nhmrc Clinical Trials Centre, University of Sydney, 2050 - Sydney/AU
  • 2 Dept Of Medical Oncology, Macarthur Cancer Therapy Centre, Sydney/AU
  • 3 Sydney Medical School, University of Sydney, Sydney/AU
  • 4 Lambert Initiative For Cannabinoid Therapeutics, University of Sydney, Sydney/AU
  • 5 Sansom Institute For Health Research, University of South Australia, Adelaide/AU
  • 6 Dept Of Medical Oncology, Calvary Mater Newcastle, Newcastle/AU
  • 7 Dept Of Medical Oncology, Mid-North Coast Cancer Institute, Coffs Harbour/AU
  • 8 Dept Of Medical Oncology, Central West Cancer Care Centre, Orange Health Service, Orange/AU
  • 9 Dept Of Medical Oncology, Illawarra Cancer Care Centre, Illawarra Shoalhaven Local Health District, Wollongong/AU
  • 10 Dept Of Medical Oncology, Chris O'Brien Lifehouse, Sydney/AU
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Resources

Abstract 4155

Background

Up to half of patients receiving chemotherapy of moderate or high emetic risk experience CINV despite optimal anti-emetic prophylaxis. Limited evidence suggests cannabinoid medicine in the form of tetrahydrocannabinol (THC) may reduce CINV, and addition of cannabidiol (CBD) may improve efficacy and tolerance. The aim of this multi-centre, randomised, placebo-controlled, phase II/III trial is to determine efficacy and cost-effectiveness of addition of an oral cannabinoid-rich THC/CBD cannabis extract for control of CINV.

Trial design

The target population is adult patients experiencing CINV during moderate and highly emetogenic chemotherapy regimens despite appropriate anti-emetic therapy, who are scheduled to receive at least 2 more consecutive cycles (A, B and, where applicable, C). Treatment consists of oral THC 2.5mg/CBD 2.5mg (Tilray TN-TC11M) capsules or placebo TDS days -1 to 5, in addition to guideline-consistent anti-emetics, including rescue medications. Patients will start with 1 tablet PO TDS and can dose-titrate to a maximum of 4 tables PO TDS based on nausea control and side-effects. In the pilot trial (N = 80), subjects are randomised for cycle A, cross-over for cycle B, and nominate preferred treatment for cycle C. The planned definitive trial (N = 250) will randomise subjects to investigational product or placebo for cycles A, B and C in a parallel design. The primary end-point is the proportion of patients gaining a complete response (no emesis and no use of rescue medications) (0 – 120h), with additional end-points of (i) complete response, (ii) no emesis, (iii) no significant nausea and (iv) no use of rescue medication during the a) acute, b) delayed, and c) overall phases of cycle A, B and C, (iv) adverse events, (v) quality of life, and (vi) cost-effectiveness. As of 09/05/2018, 52 of 80 patients have been recruited to the pilot study, with expected recruitment completion in 3rd quarter 2018. Funding: NSW Department of Health. Acknowledgements: Trial participants, investigators and research staff. Drug supply by Tilray.

Clinical trial identification

ACTRN: 12616001036404.

Legal entity responsible for the study

University of Sydney.

Funding

New South Wales Department of Health.

Editorial Acknowledgement

Disclosure

A. Tognela: Travel, accommodation, expenses: Merck Serono. P.S. Haber: Stock/Membership: Cleveland Biolab; Honoraria, advisory board, HCV drugs: Gilead; Research funding: Braeburn (opioid product clinical trial). M. Stockler: Research funding: Astellas Pharma, Celgene, Bayer, Bionomics, Medivation, Sanofi, Pfizer, AstraZeneca, Bristol-Myers Squibb, Roche, Amgen, Merck Sharpe & Dohme, Tilray; Travel, accommodation, expenses: Medivation/Pfizer. N. Lintzeris: Consulting/advisory role: Mundipharma International, Indivumed; Research funding: Braeburn Pharmaceuticals (to institution). J. Simes: Research grants to institution: Abbvie, AGITG, Amgen, ANZ Breast Cancer Trials Group, Astellas Pharma, Bayer Pharmaceuticals, BBI, Bristol-Myers Squibb, Cancer Australia, Cancer Institute NSW, Cure Brain Cancer Foundation, Merck-Serono, MSD, NHMRC, Novartis, Pfizer, Roche. I. McGregor: Patents, royalties, other IP: University of Sydney, Kinoxis Therapeutics. I. Olver: Research funding: MSD, Jansen. C. Gedye: Employment: Novotec CRO; Research funding: CPI for co-operative group trials supported by BMS and MSD. R.L. Morton: Honoraria: Amgen, Baxter Healthcare; Research funding: Edwards Life Sciences. P. Grimison: Research funding to institution: Tilray, Pfizer, MSD, Gilead Sciences, Boston Biochemical, Tigermed; Personal research funding: Specialised Therapeutics, Progen, Medimmune. All other authors have declared no conflicts of interest.

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