Northern Institute for Cancer Research

Early phase clinical trials in adults

Early Phase Clinical Trials in Adults

About

We are a dedicated team of clinical academics and research staff whose purpose is to design develop and deliver early phase clinical trials of novel cancer agents and combinations.

Research Leaders

Ruth Plummer
Yvette Drew
Alastair Greystoke
Steve O'Brien

Some of our research nurses on a trials day.

Facilities

Facilities

We are based on a dedicated cancer clinical trials unit, fully equipped for patient treatment and complex sample collection and processing to a high regulatory quality.  The trials unit is located within a regional cancer centre, supported by a comprehensive acute hospital with fully equipped resuscitation and intensive care teams on site. The unit is fully supported with diagnostic and interventional radiology, medical physics and a clinical trials pharmacy with a specials manufacturing licence.  Multi-disciplinary clinics in cardiology and ophthalmology are run weekly for toxicity evaluation and safety assessment.  A dedicated biomarker clinic enables annotated sample collection and molecular profiling of all patients recruited to studies.

Clinical trials and translational studies

Clinical trials and translational studies

We have a very active portfolio of early phase and translational studies, seeing >300 new patients per annum with solid tumours from a patient catchment area of 3.5 million.  We have taken >10 first-in-class agents into the clinic in recent years, from small molecule inhibitors to novel antibodies and proteins.

The clinical team is closely aligned with the pharmacology and mechanistic biomarker teams providing a seamless route for biomarker validation and delivery within clinical trials. Translational research interests focus on gynaecological (Drew), lung (Greystoke) and melanoma (Plummer), with each clinical PI working closely with NICR bioscientists to support laboratory cancer biology research and PhD studentships.

Publications

Danilenko M, Stamp E, Stocken DD, Husain A, Zangarini M, Cranston A, Stones R, Sinclair N, Hodgson K, Bowett SA, Roblin D, Traversa S, Plummer R, Veal G, Langtry JAA, Ashworth A, Burn J, Rajan N. Targeting tropomyosin receptor kinase in cutaneous CYLD defective tumors (TRAC): A randomised placebo-controlled early phase trial with pegcantratinib. JAMA Dermatology 2018, 154(8), 913-921. 

Escudier B, Faivre S, Van Cutsem E, Germann N, Pouget J-C, Plummer R, Vergote I, Thistlethwaite F, Bjarnason GA, Jones R, Mackay H, Edeline J, Fartoux L, Hirte H, Oza A. A Phase II Multicentre, Open-Label, Proof-of-Concept Study of Tasquinimod in Hepatocellular, Ovarian, Renal Cell, and Gastric Cancers. Targeted Oncology 2017, 12(5), 655-661.
 
Long GV, Hauschild A, Santinami M, Atkinson V, Mandal M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Schadendorf D, Lesimple T, Plummer R, Ji R, Zhang P, Mookerjee B, Legos J, Kefford R, Dummer R, Kirkwood JM. Adjuvant Dabrafenib plus Trametinib in stage III BRAF-mutated melanoma. New England Journal of Medicine 2017, 377(19), 1813-1823.
 
Cranston A, Stocken DD, Stamp E, Roblin D, Hamlin J, Langtry J, Plummer R, Ashworth A, Burn J, Rajan N. Tropomyosin Receptor Antagonism in Cylindromatosis (TRAC), an early phase trial of a topical tropomyosin kinase inhibitor as a treatment for inherited CYLD defective skin tumours: study protocol for a randomised controlled trial. Trials 2017, 18, 111.
 
Jamieson D, Griffin MJ, Sludden J, Drew Y, Cresti N, Swales K, Merriman M, Allen R, Bevan P, Buerkle M, Mala C, Coyle V, Rodgers L, Dean E, Greystoke A, Banerji U, Wilson RH, Evans TRJ, Anthoney A, Ranson M, Boddy AV, Plummer R. A phase I pharmacokinetic and pharmacodynamic study of the oral mitogen-activated protein kinase kinase (MEK) inhibitor, WX-554, in patients with advanced solid tumours. European Journal of Cancer 2016, 68, 1-10.
 

Drew Y, Ledermann J, Hall G, Rea D, Glasspool R, Highley M, Jayson GC, Sludden J, Murray J, Jamieson D, Halford S, Acton G, Backholer Z, Mangano R, Boddy A, Curtin N, Plummer E. (2016) Phase 2 multicentre trial investigating intermittent and continuous dosing schedules of the poly(ADP-ribose) polymerase inhibitor rucaparib in germline BRCA mutation carriers with advanced ovarian and breast cancers. Br J Cancer. 114(7), 723-730.

Migden MR, Guminski A, Gutzmer R, Dirix L, Lewis KD, Combemale P, Herd RM, Kudchadkar R, Trefzer U, Gogov S, Pallaud C, Yi T, Mone M, Kaatz M, Loquai C, Stratigos AJ, Schulze HJ, Plummer R, Chang AL, Cornélis F, Lear JT, Sellami D, Dummer R. (2015) Treatment with two different doses of sonidegib in patients with locally advanced or metastatic basal cell carcinoma (BOLT): a multicentre, randomised, double-blind phase 2 trial. Lancet Oncol. 16(6), 716-728.

Spicer J, Baird R, Suder A, Cresti N, Corbacho JG, Hogarth L, Frenkel E, Matsumoto S, Kawabata I, Donaldson K, Posner J, Sarker D, Jodrell D, Plummer R. (2015) Phase 1 dose-escalation study of S-222611, an oral reversible dual tyrosine kinase inhibitor of EGFR and HER2, in patients with solid tumours. Eur J Cancer. 51(2), 137-145.

Plummer R, Lorigan P, Steven N, Scott L, Middleton MR, Wilson RH, Mulligan E, Curtin N, Wang D, Dewji R, Abbattista A, Gallo J, Calvert H. (2013) A phase II study of the potent PARP inhibitor, Rucaparib (PF-01367338, AG014699), with temozolomide in patients with metastatic melanoma demonstrating evidence of chemopotentiation. Cancer Chemother Pharmacol. 71(5) 1991-1199.

Yap, T. A., L. Vidal, J. Adam, P. Stephens, J. Spicer, H. Shaw, J. Ang, G. Temple, S. Bell, M. Shahidi, M. Uttenreuther-Fischer, P. Stopfer, A. Futreal, H. Calvert, J. S. de Bono, and R. Plummer. 2010. 'Phase I trial of the irreversible EGFR and HER2 kinase inhibitor BIBW 2992 in patients with advanced solid tumors', J Clin Oncol, 28: 3965-72.

Drew, Y., E. A. Mulligan, W. T. Vong, H. D. Thomas, S. Kahn, S. Kyle, A. Mukhopadhyay, G. Los, Z. Hostomsky, E. R. Plummer, R. J. Edmondson, and N. J. Curtin. 2011. 'Therapeutic potential of poly(ADP-ribose) polymerase inhibitor AG014699 in human cancers with mutated or methylated BRCA1 or BRCA2', J Natl Cancer Inst, 103: 334-46.