NIHR Performance Metrics - Initiating Clinical Research. Quarter 2 ( )

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1 NIHR Performance Metrics - Initiating Clinical Research Quarter 2 ( ) Research Ethics Committee Reference Number Name of Trial Date of Receipt of Valid Research Application Date of First Patient Recruited Benchmark Met Reasons for delay 13/WA/ /SC/0515 A Randomized, DoubleBlind, Phase III Study of the Efficacy and Safety of Gemcitabine in Combination With TH302 Compared With Gemcitabine in Combination With Placebo in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Validity study for the Dejour Test,a non-invasive way of measuring oxygen sensitivity from an exhaled breath test, & its use in chronic type II respiratory failure 23/08/ /02/2014 No Rare Disease 13/09/ /01/2014 No Sponsor delays in submission documentation 10/H0802/46 Revascularisation for Ischaemic Ventricular Dysfunction (REVIVEDBCIS2) 16/09/ /06/2014 No Strict Eligibility 13/LO/0002 A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of GS-1101 (CAL-101) in Combination with Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia.(GS-US ) 16/09/ /03/2014 No Halt in recruitment A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton s Tyrosine 13/YH/0011 Kinase Inhibitor PCI versus Chlorambucil in Patients 65 Years or Older Closed early to 01/10/2013 CLOSED N/A with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic recruitment Lymphoma 13/NI/ /YH/ /LO/ /SC/0452 A phase II, randomised, doubleblind, placebo controlled, multicentre trial to assess the oral corticosteroidsparing effect of lebrikizumab in patients with with severe corticosteroiddependant asthma A Randomised Trial of the FLAMSABU Conditioning Regimen in Patients with Acute Myeloid Leukaemia and Myelodysplasia Undergoing Allogeneic Stem Cell Transplantation An efficacy and mechanism evaluation study of Levosimendan for the Prevention of Acute organ Dysfunction in Sepsis (LeoPARDS) A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Longterm Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508delCFTR Mutation (VX ) 03/10/ /02/2014 No NHS Permission delayed 09/10/ /02/2014 No 15/10/ /03/2014 No Halt in recruitment 22/10/ /02/2014 No Rollover study awaiting patient to complete main study

2 11/NW/ /SW/ /LO/ /NW/ /NW/ /WM/ /YH/0012 HZC113782: A Clinical Outcomes Study to compare the effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease. A randomized clinical trial to compare early versus delayed endovenous treatment of superficial venous reflux in patients with chronic venous ulceration A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir/abacavir/lamivudine once daily compared to atazanavir and ritonavir plus tenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naïve women A 24Week, International, Multicentre, Randomised, Parallelgroup, Doubleblind Trial to Evaluate Metformin Extended Release Monotherapy Compared to Metformin Immediate Release Monotherapy in Adult Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control with Diet and Exercise. (CV181206) Open-label, uncontrolled Phase II trial of intravenous PI3K inhibitor BAY in patients with relapsed, indolent or aggressive Non-Hodgkin s lymphomas A dose-finding phase Ib study followed by a randomized, double-blind phase II study of carboplatin and paclitaxel with or without buparlisib in patients with previously untreated metastatic non-small cell lung cancer (NSCLC) of squamous histology. (BASALT 2) An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (PCI versus Chlorambucil) 23/10/ /01/2014 No 29/10/ /01/2014 No Strict Eligibility 30/10/2013 N/A No Strict Eligibility 07/11/2013 No Late Site Activation & Strict Eligibility 12/11/2013 N/A No Rare Disease 12/11/2013 CLOSED N/A 12/11/2013 CLOSED N/A Study closed due to dosing issues Closed early to recruitment 13/LO/1258 SMT C A Phase 1, Open-label, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Paediatric Patients with Duchenne 13/11/ /02/2014 No Site activation delay Muscular Dystrophy (SMT C11002) 13/EM/0030 Speed of Increasing milk Feeds Trial 14/11/ /03/2014 No Staff availability 13/SC/ /WM/0187 A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF LEBRIKIZUMAB IN ADOLESCENT PATIENTS WITH SEVERE UNCONTROLLED ASTHMA WHO ARE ON INHALED CORTICOSTEROIDS AND A SECOND CONTROLLER MEDICATION (WB28183) A randomised controlled trial of reinforcement of closure of stoma site using a biological mesh 19/11/2013 N/A No 25/11/ /05/2014 No Staff Availability Staff Training

3 13/EE/ /WA/ /LO/ /YH/ /NW/ /NW/ /LO/1245 A Phase 3B Randomized, Open-Label, Multi-Center Trial Assessing Sofosbuvir + Ribavirin for 16 or 24 Weeks and Sofosbuvir + Pegylated Interferon + Ribavirin for 12 Weeks in Subjects with Genotype 2 or 3 Chronic HCV Infection. (GS-US ) A randomised phase II trial of Olaparib maintenance versus placebo monotherapy in patients with non small cell lung cancer Insight Insulin Pump EU Study: A European Multicenter Study to Evaluate the Accu-Chek Insight Insulin Pump in Routine Practice STOMP: Small cell lung cancer Trial of Olaparib (AZD2281) as Maintenance Programme: a randomised, double blind, multicentre phase II trial A multicentre, randomised, doubleblind, parallel group, placebocontrolled, phase III efficacy and safety study of benralizumab (MEDI563) added to highdose inhaled corticosteroid plus longacting B2agnoist in patients with uncontrolled asthma (SIROCCO) A phase III multicenter, randomized study of oral LDK378 versus standard chemotherapy in previously untreated adult patients with ALK rearranged (ALK positive), stage IIIB or IV, non squamous nonsmall cell lung cancer (CLDK378A2301) A Phase 1b, Multicenter, Pilot, Randomized, Double-blind Trial to Determine the Pharmacokinetics and Pharmacodynamics of Orally Administered Tolvaptan 3.75, 7.5, and 15 mg Tablets in Subjects with Syndrome of Inappropriate Antidiuretic Hormone Secretion (Otsuka ) 25/11/ /01/2014 YES 03/12/ /05/2014 No Site activation delay 09/12/ /08/2014 No Contracting delays and Staff availability 14/01/2014 N/A No Strict Eligibility 03/02/ /05/2014 No & Sponsor delay 19/02/ /08/2014 No Rare Disease 26/02/ /04/2014 YES 13/YH/0282 Openlabel, Phase IIIb study to evaluate the efficacy and safety of subcutaneous (SC) Tocilizumab monotherapy or combination therapy with methotrexate (MTX) or other nonbiologic disease modifying antirheumatic drugs (DMARDs) in patients with severe Rheumatoid Arthritis (RA) who are being treated with an antitumournecrosis factor (antitnf) agent and that have not achieved an adequate response to treatment 14/03/ /05/2014 YES 13/NW/0829 A 52 week, double-blind, randomized, multinational, multi-centre, 2 arm parallel group, active controlled clinical trial of fixed combination of beclometasone dipropionate plus formoterol fumarate plus glycopyrrolate bromide administered via pmdi (CHF 5993) versus fixed combination of beclometasone dipropionate plus formoterol fumarate administered via pmdi in Patients with Chronic Obstructive Pulmonary Disease 18/03/ /05/2014 YES

4 13/LO/ /YH/ /WM/ /LO/ /WA/ /EM/0310 A double-blind, randomized, placebo-controlled, cross-over study to evaluate the clinical efficacy and safety of subcutaneous administration of human plasmaderived C1-esterase inhibitor in the prophylactic treatment of hereditary angioedema (CSL830_3001) 18/03/2014 CLOSED N/A A 52 WEEK, PHASE 3 DOUBLE-BLIND, RANDOMIZED, PLACEBOCONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF PF IN SUBJECTS WITH HETEROZYGOUS FAMILIAL 24/03/ /06/2014 No Strict Eligibility HYPERCHOLESTEROLEMIA (B ) A Multinational, Randomised, DoubleBlind,Placebo Controlled Trial to Evaluate the Effect of Ticagrelor 90 mg twice daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients with Type 2 Diabetes Mellitus 01/04/2014 CLOSED N/A (THEMIS) A phase II randomised trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs cyclophosphamide, velcade and dexamethasone (CVD) for first relapse or primary refractory multiple myeloma. A Randomised, Double-Blind, Placebo-Controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment with MK3102 in Subjects with Type 2 Diabetes Mellitus The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients a pilot study 03/04/ /07/2014 No 04/04/ /07/2014 No Study closed to nonrecruiting sites Study closed to nonrecruiting sites & Site Initiation Delay 07/04/2014 No Sponsor delays 14/SC/0104 AZD1722 fir phosphate lowering in dialysis 08/04/ /07/2014 No Site activation delay 12/NW/ /LO/ /WM/ /WM/0057 A pragmatic randomised controlled trial comparing the effectiveness and cost effectiveness of levetiracetam and zonisamide versus standard treatments for epilepsy: a comparison of Standard And New Antiepileptic Drugs A multicentre phase III randomised controlled single masked clinical trial to test the clinical efficacy of LightMasks at preventing dark adaptation in the treatment of early diabetic macular oedema BCoS-Care:A pilot study for developing and evluating a care pathway for cognitive problems after stroke Multi-centre randomised controlled trial to compare the clinical and costeffectiveness of a vein bypass first with a best endovascular first revascularisation strategy for severe limb ischaemia due to infra-popliteal arterial disease: Bypass vs. Angioplasty in Severe Ischaemia of the Leg. 15/04/ /07/2014 No Site activation delay 29/04/ /09/2014 No NHS Permission delayed 13/05/ /07/2014 No Sponsor delay 14/05/ /07/2014 YES 13/SC/043 Adjuvant steroids in adults with pandemic influenza 14/05/2014 N/A No Pandemic Study 14/SC/0065 A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus 19/05/ /09/2014 No Strict Eligibility

5 08/H0305/38 13/EM/0349 Evaluation of a tailored text message intervention for pregnant smokers (MiQuit): A proof of concept trial 20/05/ /06/2014 YES MANTA - A Phase II, randomized, placebo-controlled study of Fulvestrant in combination with the dual mtor inhibitor AZD2014 or Everolimus or Fulvestrant 21/05/ /07/2014 Yes alone in ER-positive metastatic breast cancer 14/EE/0032 Treating dry eyes and corneal ulcers with fingerprick autologous blood 03/06/2014 N/A No 14/SC/ /NI/ /EM/ /NW/ /LO/ /H1005/28 14/YH/ /ES/0005 A multi-centre randomised, double blind, placebo-controlled, parallel group trial of the effectiveness of the nocturnal use of a Temperature Controlled Laminar Airflow (TLA) Device (Airsonett ) in adults with poorly controlled, severe allergic asthsma A Phase 4, Open label, Single-Arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or PostEssential Thrombocythemia Myelofibrosis A randomised, double blind, multi-center, placebo-controlled study to evaluate the efficacy, safety, and tolerability of NT100 in pregnant women with a history of unexplained recurrent pregnancy loss (RPL) A Multicenter Phase 3 Randomized Open-Label Study of Bosutinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukaemia Molecular genetics of adverse drug reactions: from candidate genes to genome wide association studies. Front-Line therapy in CLL: Assessment of Ibrutinib + Rituximab (A Phase III trial to assess ibrutinib + R against FCR in previously untreated patients with Chronic Lymphocytic Leukaemia (CLL) A phase 3, multi centre, randomized, double blind study to compare the efficacy and safety of oral azacitidine plus best supportive care versus placebo plus best supportive care in subjects with red blood cell transfusion dependent anaemia and thrombocytopenia due to ipss lower-risk myelodysplastic syndromes 11/06/ /08/2014 YES Unpredicatable Patient Population 25/06/2014 N/A No Rare Disease 30/06/2014 N/A No Strict Eligibility 17/07/ /08/2014 Yes 04/08/2014 N/A Within Benchmark Within Benchmark 19/08/2014 N/A Within Benchmark Within Benchmark 26/08/2014 N/A Within Benchmark Within Benchmark 15/09/2014 N/A Within Benchmark Within Benchmark 11/H1016/3 Manchester Vascular Access Study (MANVAS) 26/09/2014 N/A Within Benchmark Within Benchmark 13/LO/0108 A randomised phase II study comparing LEnalidomide plus rituximab, GEmcitabin e and methylprednisolone (LRGEM) to rituximab, gemcitabine, methylprednisolo 29/09/2014 ne and cisplatin (R GEM P) in second line treatment of Diffuse Large B cell lymph N/A Within Benchmark Within Benchmark oma (DLBCL)