Studies proceeding under pre HRA-Approval system (NHS Permission)

Transcription

1 15/NW/ Studies proceeding under pre HRA-roval system (NHS Permission) A MULTI-CENTRE RANDOMISED CLINICAL TRIAL OF BIOMARKER-DRIVEN MAINTENANCE TREATMENT FOR FIRST- LINE METASTATIC COLORECTAL CANCER (MODUL) 29/07/ /09/ /LO/ /LO/ /SC/ /SC/ A phase II randomised trial of biomarkers to assess (dose-) response in patients with metastatic castration resistant prostate cancer treated with radium-223 A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction with EpaNova in HiGh Cardiovascular Risk PatienTs with Hypertriglyceridemia (STRENGTH) A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Nivolumab versus Ipilimumab after Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects who are at High Risk for Recurrence Pharmacogenetics Blood Sample Cluster randomised trial of the clinical and cost effectiveness of the i-gel supraglottic airway device versus tracheal intubation in the initial airway management of out of hospital cardiac arrest 08/07/ /07/2015 Restrictive Lipid ranges made it more difficult than anticipated to recruit. This was a global 19/08/ /11/2015 issue with the study. The study team are Neither looking to amend the target number of patients. 02/07/ /07/ /08/ /09/2015 1

2 15/LO/ A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects with Chemotherapynaive astatic Castration-resistant Prostate Cancer (mcrpc) 21/10/ /12/ /EE/ NN Efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes. 16/12/ /02/ /NW/ A randomised, double-blind, double-dummy, placebo-controlled, parallel-group multicentre clinical proof-of-principle trial in adult subjects with newly diagnosed type 1 diabetes mellitus investigating the effect of NNC and liraglutide on preservation of beta-cell function. No eligible patients have been seen. The 17/12/2015 N/A study has very strict inclusion/exclusion criteria. As a result the target for the study is Neither only 1 patient in total. 15/SC/ A Phase III, Open-label, Randomised, Multicentre, International Study of MEDI4736, Given as Monotherapy or in Combination with Tremelimumab, Determined by PD-L1 Expression, Versus Standard of Care in s with Locally Advanced or astatic Non-Small Cell Lung Cancer (Stage IIIB-IV) who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum-based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC) Delays with contracts at the sponsors end and a delayed SIV. Two weeks after having 23/12/2015 N/A the'green light' one arm was closed which Sponsor enormously restricted likelihood of recruiting - site were unaware of this possibility. 2

3 15/NW/ A MULTICENTER, OPEN-LABEL, SINGLE- ARM SAFETY STUDY OF HERCEPTIN SC IN COMBINATION WITH PERJETA AND DOCETAXEL IN TREATMENT OF PATIENTS WITH HER2-POSITIVE ADVANCED BREAST CANCER (METASTATIC OR LOCALLY RECURRENT) This study has a small target. The 09/10/ /04/2016 Team had one eligible patient identified within 70 day window but they became too Neither unwell to go onto the study. 15/SC/ A PHASE 1B, OPEN-LABEL, DOSE- FINDING STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB C) IN COMBINATION WITH AXITINIB (AG ) IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED RENAL CELL CANCER 04/11/ /12/ /LO/ Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) versus Pegylated Liposomal Doxorubicin or Topotecan in s with Platinum-resistant Ovarian Cancer (CORAIL Trial) The site were awaiting log-in details from the 16/11/ /02/2016 Sponsor for at least one month which Sponsor prohibited recruitment during this period. 14/SC/ A phase III, multi-centre, double-blind, placebo-controlled randomised trial with four parallel cohorts. Each of the four cohorts are tumour site-specific (breast, colorectal, gastro oesophageal and prostate cancer) 27/11/ /12/ /SC/ The efficacy and cost effectiveness of Real Time Ultrasound Elastography in the investigation of thyroid nodules and the diagnosis of thyroid cancer. 01/02/ /02/2016 3

4 15/LO/ Effect of Remote Ischaemic Conditioning on clinical outcomes in ST-segment elevation myocardial infarction patients undergoing Primary Percutaneous Coronary Intervention (ERIC-PPCI): A multicentre randomised controlled clinical trial 12/02/ /02/ /SW/ Male synthetic sling versus Artificial urinary Sphincter Trial for men with urodynamic stress incontinence after prostate surgery: Evaluation by Randomised controlled trial 25/02/ /04/ /WS/ MSD MK 3475 Protocol 062 : A Randomized, Active Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil versus Placebo + Cisplatin + 5-Fluorouracil as First- Line Treatment in Subjects with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. 04/03/ /04/ /LO/ An Open-Label, Multicenter Clinical Trial with Nivolumab (BMS ) Monotherapy in Subjects with Advanced or astatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) who Have Received at Least One Prior Systemic Regimens for the Treatment of Stage IIIb/IV SqNSCLC. 18/01/ /01/2016 4

5 15/LO/ A Randomised three-arm, open label, Phase II study of continuous Selumetinib versus continuous or interrupted Selumetinib in combination with weekly Paclitaxel in astatic Uveal Melanoma Rare tumour type study with low overall 14/01/ /05/2016 Neither target 15/LO/ /LO/ RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY EVALUATING TAS-102 PLUS BEST SUPPORTIVE CARE (BSC) VERSUS PLACEBO PLUS BSC IN PATIENTS WITH METASTATIC GASTRIC CANCER REFRACTORY TO STANDARD TREATMENTS Using daily self-administered indirect moxibustion to Zusanli ST-36 to reduce chemotherapy induced pancytopenia: a feasibility study. Fewer patients than anticipated referred from District General Hospitals, patients currently 08/03/2016 N/A on 2nd line treatment are responding well Neither and therefore have not progressed to 3rd line treatment. 18/02/ /03/ /NE/ Multi-centre randomised controlled trial with economic evaluation and nested qualitative study comparing early structured physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a frozen shoulder (Adhesive Capsulitis) 23/03/ /05/ /NW/ Adjuvant immunotherapy with anti-pd-1 monoclonal antibody Pembrolizumab (MK- 3475) versus placebo after complete resection of high-risk Stage III melanoma: A randomized, double- blind Phase 3 trial of the EORTC Melanoma Group 17/03/2016 N/A lication (VRA) submitted CSP closure statement and CRN ndence citing Department of Health Neither 5

6 15/WS/ A Phase III open-label, multicenter trial of avelumab (MSB C) versus docetaxel in subjects with non-small cell lung cancer that has progressed after a platinumcontaining doublet lication (VRA) submitted 22/03/2016 N/A CSP closure statement and CRN Neither ndence citing Department of Health 15/EM/ A Randomized, Double-blind, Placebocontrolled Study of the Safety and Efficacy of Amatuximab in Combination with Pemetrexed and Cisplatin in Subjects with Unresectable Malignant Pleural Mesothelioma lication (VRA) submitted 22/03/2016 N/A CSP closure statement and CRN Neither ndence citing Department of Health 13/EE/ A randomised placebo-controlled trial of synchronous NIMorazole versus RADiotherapy alone in patients with locally advanced head and neck squamous cell carcinoma not suitable for synchronous chemotherapy or cetuximab. lication (VRA) submitted 23/03/2016 N/A CSP closure statement and CRN Neither ndence citing Department of Health 16/LO/ A Phase I Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 using the Intra-patient Escalation Dosing Regimen in s with Advanced Uveal Melanoma. lication (VRA) submitted 23/03/2016 N/A CSP closure statement and CRN Neither ndence citing Department of Health 6

7 15/EE/ A Randomized, Double-Blind, Placebo- Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab in Insulin Treated s with Type 1 or Type 2 Diabetes and With Hypercholesterolemia at High Cardiovascular Risk Not Adequately Controlled on Maximally Tolerated LDL-C Lowering Therapy. 23/03/ /05/ /LO/ A double-blind randomised controlled clinical trial to determine the efficacy of paclitaxelassisted balloon angioplasty of venous stenoses in haemodialysis access lication (VRA) submitted 22/03/ /06/2016 CSP closure statement and CRN Neither ndence citing Department of Health 15/NW/ A twenty-six week, randomized, open-label, 2- arm parallel group real world pragmatic trial to assess the clinical and health outcomes benefit of transition to Toujeo compared to standard of care insulin, in basal insulin treated patients with uncontrolled type 2 diabetes mellitus, with six-month extension lication (VRA) submitted 23/03/2016 N/A CSP closure statement and CRN Neither ndence citing Department of Health 7

8 15/SC/ MEDI4736 combinations in metastatic renal cell carcinoma (CALYPSO) lication (VRA) submitted 17/03/2016 N/A CSP closure statement and CRN Neither ndence citing Department of Health HRA-approval studies Date site invited Date site selected HRA roval date Date site confirmed by Sponsor Date site confirmed Date site ready to start first patient recruited for delay recruiting first patient 16/NW/ An open-label, randomised, phase 2 study comparing S plus bevacizumab to capecitabine plus bevacizumab in patients with previously untreated metastatic colorectal cancer who are non-eligible for intensive therapy 05/02/ /03/ /04/2016 N/A N/A N/A N/A Inaccurate information present in the patient information sheet designed by Sponsor caused delays in clarification of study treatment. Sponsor 8