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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

5316 - ACELARATE – A randomised Phase III, open label, clinical study comparing NUC-1031 with gemcitabine in patients with metastatic pancreatic carcinoma

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Topics

Cytotoxic Therapy

Tumour Site

Pancreatic Cancer

Presenters

Daniel Harrison Palmer

Citation

Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282

Authors

D. Harrison Palmer1, P.J. Ross2, P. Silcocks1, W. Greenhalf3, O. Faluyi4, Y.T. Ma5, J. Wadsley6, C. Rawcliffe1, J. Neoptolemos7, J.W. Valle8, H. Wasan9, N. Starling10, K. Patel11, J. Bridgewater12

Author affiliations

  • 1 Liverpool Cancer Trials Unit, University of Liverpool, L69 3GL - Liverpool/GB
  • 2 ., Guy's and St Thomas' NHS Foundation Trust, London/GB
  • 3 Liverpool Experimental Cancer Medicine Centre, University of Liverpool, L69 3GL - Liverpool/GB
  • 4 Medical Oncology, Clatterbridge Cancer Centre NHS Foundation Trust, CH63 4JY - Wirral/GB
  • 5 Medical Oncology, University Hospitals Birmingham NHS Foundation Trust, B15 2GW - Birmingham/GB
  • 6 Medical Oncology, Sheffield Teaching Hospital NHS Foundation Trust, Sheffield/GB
  • 7 Department Of General Surgery, University of Heidelberg, Heidelberg/DE
  • 8 Medical Oncology, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
  • 9 Hammersmith Hospital, Imperial College Healthcare NHS Trust, W12 0HS - London/GB
  • 10 Medical Oncology, Royal Marsden Hospital NHS Foundation Trust, SW3 6JJ - London/GB
  • 11 Medical Oncology, Churchill Hospital, Oxford/GB
  • 12 Oncology, University College London Hospitals, London/GB
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Resources

Abstract 5316

Background

Pancreatic ductal adenocarcinoma (PDAC) is predicted to be the second leading cause of cancer-related death by 2030 (Rahib et al, 2014). The overall 5-year survival rate is currently less than 7%. Gemcitabine is used for patients who are not suitable for combination therapy, but the response is poor at less than 10% (Conroy et al, 2011). Gemcitabine efficacy is limited due to intrinsic or acquired resistance mechanisms associated with transport, activation and breakdown. NUC-1031, a phosphoramidate transformation of gemcitabine, is designed to overcome the three key resistance mechanisms responsible for a poor survival prognosis to gemcitabine. In a Phase I study, NUC-1031 was well tolerated and demonstrated anti-tumour activity across a wide range of advanced cancers, including PDAC (Blagden et al, ASCO 2015). This ongoing Phase III study is designed to compare NUC-1031 with gemcitabine as first-line treatment in patients with PDAC who are unsuitable for combination chemotherapy.

Trial design

First-line patients with metastatic PDAC are being randomised to either NUC-1031 (825 mg/m2) or gemcitabine (1000 mg/m2) on days 1, 8 and 15 of a 28-day cycle until disease progression. Patients unsuitable for combination chemotherapy with a PS of 0-2 are eligible. Over 125 patients have been randomised across more than 20 centres. To detect a hazard ratio of 0.705 between the two arms, 270 events must be obtained from 328 patients, assuming a median survival of 6 months in the control (gemcitabine) arm. The primary outcome measure is overall survival. Secondary outcome measures include progression free survival, objective response rate, disease control rate, quality of life and safety. Translational research will explore the use of biomarkers for predictive benefit of NUC-1031 over gemcitabine.

Clinical trial identification

ISRCTN16765355.

Legal entity responsible for the study

Clatterbridge Cancer Centre NHS Foundation Trust.

Funding

NuCana Biomed Ltd.

Editorial Acknowledgement

Not applicable.

Disclosure

D. Harrison Palmer, W. Greenhalf: Research grant, travel bursary: Nucana Biomed Ltd. J. Wadsley: Honoraria: AstraZeneca, Sanofi-Genzyme, Eisai, Bayern, celgene, Lilly, Novartis. Consultancy, Advisory: AstraZeneca, Sanofi-Genzyme, Eisai, Bayer, Celgene, Lilly, Novartis; Research funding: AstraZeneca, Sanofi-Genzyme. J. Neoptolemos: Travel grant: Nucana Biomed Ltd. J.W. Valle, H. Wasan: Research funding: Nucana Biomed Ltd. All other authors have declared no conflicts of interest.

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