Current CTU studies Apr 14 STUDIES OPEN TO RECRUITMENT TRIAL No. STUDY DESCRIPTION P.I. CONTACT SPONSOR/ PORTFOLIO DATE OPENED BMT ON/2011/3861 PRoT4 (Prophylactic Transfer of CD4 Lymphocytes) ON/2012/4116 UK HAPLO Study Multicentre randomised phase II study to evaluate the efficacy of prophylactic transfer of CD4 lymphocytes after Tcell depleted reduced intensity HLA-identical sibling transplantation for indolent nonHodgkin's lymphoma and CLL A UK multicentre phase II study of haploidentical stem cell transplantation in patients with haematological Dr S Robinson Dr R Protheroe Jon Heywood Research Nurse x 26741/bleep 2852 Helen Saldanha Trial Coordinator x 26740 Jon Heywood Research Nurse x 26741/bleep 2852 Helen Saldanha Trial Coordinator x 26740 CRUK (NIHR) 26/10/2012 UCL (NIHR) 26/06/2013 EORTC (NIHR) 26/04/2011 CRUK (NIHR) 15/11/2012 Commercial 02/08/2013 BRAIN ON/3468 BR14 EORTC 26053/22054 Adjuvant Location of trial treatment: Outpatient oral chemotherapy and Radiotherapy ON/4041 OPARATIC eCRF Location of trial treatment: NBT surgery & oral outpatient chemotherapy. ON/4315 ACT IV Phase III trial on Concurrent and Adjuvant Temozolomide chemotherapy in non1p/19q deleted anaplastic glioma. The CATNON Intergroup trial. A Cancer Research UK Phase I trial of olaparib (AZD2281), an oral PARP Inhibitor, in combination with extended low-dose oral temozolomide in patients with relapsed glioblastoma An International, Randomised, DoubleBlind, Controlled Study of Rindopepimut/GMCSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIIIpositive Glioblastoma Vicki Kitchker Research Nurse x 26744/bleep 3279 Dr K Hopkins Angela Webb Research Nurse x 26753/bleep 2195 Matt Baxter Asst CTU Manager x 26734 Angela Webb Research Nurse x 26753/bleep 2195 Dr K Hopkins Vicki Kitchker Research Nurse x 26744/bleep 3279 Matt Baxter Asst. CTU Manager x 26735 Angela Webb Research Nurse x 26753/bleep 2195 Dr K Hopkins Vicki Kitchker Research Nurse x 26744/bleep 3279 Matt Baxter Asst. CTU Manager x 26735 STUDIES OPEN TO RECRUITMENT TRIAL No. ON/4297 TAVAREC ON/4382 TAMIGA STUDY DESCRIPTION Randomised trial assessing the significance of Bevacizumab in recurrent grade II and Grade III gliomas. The TAVAREC trial. A double-blind, placebo-controlled, randomized, Phase IIIb trial evaluating the efficacy and safety of standard of care (SOC) +/-continuous bevacizumab treatment following progression of disease (PD) in patients with glioblastoma (GBM) after first (1st)-line treatment with radiotherapy, temozolomide and bevacizumab (MO28347) P.I. CONTACT PORTFOLIO DATE OPENED EORTC (NIHR) 22/01/2014 Commerical (NIHR) 31/01/2014 SPONSOR/ Vicki Kitchker Research Nurse x 26744/bleep 3279 Dr C Herbert Angela Webb Research Nurse x 26753/bleep 2195 Matt Baxter Asst. CTU Manager x 26735 Vicki Kitchker Research Nurse x 26744/bleep 3279 Dr K Hopkins Angela Webb Research Nurse x 26753/bleep 2195 Matt Baxter Asst. CTU Manager x 26735 BREAST ON/3235 MOSS Location of trial treatment: LG2 R/T Pre-treatment The tumour bed as target for breast irradiation following breast conserving surgery Dr A Bahl Dana Weston Research Radiographer x 22433/bleep 2436 24/08/2010 Investigator led Sylvia Pearson Snr Trial Coordinator ON HOLD FROM 01-Apr-13 x 26747 ON/3241 IMPORT HIGH Location of trial treatment: LG2 Radiotherapy Randomised trial testing dose escalated intensity modulated radiotherapy in women with higher than average local tumour recurrence risk after breast conservation surgery and appropriate systemic therapy for early breast cancer Dana Weston Research Radiographer x 26754/bleep 2436 Dr A Bahl Dorothy Griffiths Research Radiographer x 26739/bleep 3013 Helen Saldanha Trial Coordinator x 26740 ICR (NIHR) 19/07/2011 STUDIES OPEN TO RECRUITMENT TRIAL No. ON/2010/3589 BIG 3-07 (TROG 07.01) Location of trial treatment: LG2 Radiotherapy ON/3810 FAST FORWARD Location of trial treatment: LG2 Radiotherapy ON/3941 ARISTACAT Location of trial treatment: CDU ON/4082 OPTIMA Location of trial treatment: CDU STUDY DESCRIPTION P.I. Dr A Bahl Randomised clinical trial testing a 1-week course of curative whole breast radiotherapy against a standard 3-week schedule in terms of local cancer control and late adverse effects in patients with early breast cancer Dr A Bahl Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis SPONSOR/ PORTFOLIO DATE OPENED Dorothy Griffiths Research Radiographer x 26739/bleep 3013 BIG 3-07 (TROG 07.01) A Randomised Phase III Study of Radiation Doses and Fractionation Schedules for Ductal Carcinoma in Situ (DCIS) of the Breast ARomatase Inhibition plus/minus SaracaTinib as Advanced breast CAncer Therapy: a randomised phase II study of aromatase inhibition plus/minus the src-inhibitor AZD0530 in postmenopausal women with advanced breast cancer CONTACT Dana Weston Research Radiographer x 26754/bleep 2436 Lothian Health Board (NIHR) 21/11/2011 ICR / NIHR 06/02/2012 Common Services Agency (NIHR) 04/10/2012 UCL (NIHR) 12/03/2013 Helen Saldanha Trial Coordinator x 26740 Dana Weston Research Radiographer x 26754/bleep 2436 Dorothy Griffiths Research Radiographer x 26739/bleep 3013 Helen Saldanha Trial Coordinator x 26740 Liz Allison Research Nurse x 26736/bleep 2999 Dr J Braybrooke Seonaid Wright Research Nurse x 26755/bleep 2459 Angela Webb Research Nurse x 26753/bleep 2195 Robert Hollister Trial Coordinator x 26742 Dr J Braybrooke Seonaid Wright Research Nurse x 26755/bleep 2459 Robert Hollister Trial Coordinator x 26742 STUDIES OPEN TO RECRUITMENT TRIAL No. ON/4220 KATHERINE / BO27938 NCRN384 STUDY DESCRIPTION A Randomised, Multicentre, OpenLabel Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With Her2Positive Primary Breast Cancer who have Residual Tumour present pathologically in the breast or axillary lyph nodes following preoperative therapy P.I. CONTACT SPONSOR/ PORTFOLIO DATE OPENED Seonaid Wright Research Nurse x 26755/bleep 2459 Dr J Braybrooke Liz Allison Research Nurse x 26736/bleep 2999 Angela Webb Research Nurse x 26753/bleep 2195 Commercial (NIHR) 28/06/2013 Robert Hollister Trial Coordinator x 26742 COLORECTAL ON/1707 NSCCG {Also open at NBT} observational – genetic epidemiology National Study of Colorectal Cancer Genetics Dr S Falk Helen Boal Clinical Trials Officer x 26737/bleep 6342 ICR (NIHR) 14/04/2004 Location of trial treatment: Blood sample only ON/2776 FOxTROT (589) adjuvant {Cross-site trial with NBT} Liz Allison Research Nurse x 26736/bleep 2999 Fluoropyrimidine, Oxaliplatin & Targeted Receptor preOperative Therapy for colon cancer Mr M Thomas Location of trial treatment: CDU ON/3529 FOXFIRE neo-adjuvant Location of trial treatment: CDU & Oxford Jon Heywood Research Nurse x 26741/bleep 2852 Angela Webb Research Nurse x 26753/bleep 2195 Uni of B’ham 08/07/2008 (NIHR) Paul Armenise Trial Coordinator x 26743 An open-label randomised trial of 5fluorouracil, oxaliplatin and folinic acid +/interventional radioembolisation as first line treatment for patients with unresectable liver-only or liver-predominant metastatic colorectal cancer Liz Allison Research Nurse x 26736/bleep 2999 Jon Heywood Research Nurse x 26741/bleep 2852 Dr S Falk Angela Webb Research Nurse x 26753/bleep 2195 Paul Armenise Trial Coordinator x 26743 Uni of Oxford (NIHR) 08/08/2011 STUDIES OPEN TO RECRUITMENT TRIAL No. STUDY DESCRIPTION P.I. CONTACT PORTFOLIO DATE OPENED UCL (NIHR) 01/02/2012 Commercial 20/06/2012 Cardiff University 24/10/2013 SPONSOR/ Liz Allison Research Nurse x 26736/bleep 2999 ON/3562 ARISTOTLE neo-adjuvant Location of trial treatment: CDU & Treatment floor A phase III trial comparing standard versus novel CRT as pre-operative treatment for MRI defined locally advanced rectal cancer Jon Heywood Research Nurse x 26741/bleep 2852 Dr S Falk Angela Webb Research Nurse x 26753/bleep 2195 Paul Armenise Trial Coordinator x 26743 ON3912 ACORN Location of trial treatment: Observatoinal only ON/4206 COPERNICUS Avastin COloRectal Non-interventional study- an observational study of avastin® (bevacizumab) in combination with chemotherapy for treatment of first line metastatic colorectal adenocarcinoma A Phase II study of neoadjuvant chemotherapy given before short course preoperative radiotherapy (SCPRT) as treatment for patients with MRIstaged operable rectal cancer at high risk of metastatic relapse Dr S Falk Helen Boal Clinical Trials Officer x 26737/bleep 6342 Paul Armenise Trial Coordinator x 26743 Liz Allison Research Nurse x 26736/bleep 2999 Jon Heywood Research Nurse x 26741/bleep 2852 Dr S Falk Angela Webb Research Nurse x 26753/bleep 2195 Paul Armenise Trial Coordinator x 26743 Liz Allison Research Nurse x 26736/bleep 2999 ON/4378 FOCUS-4 Molecular selection of therapy in colorectal cancer: a molecularlystratified randomised controlled trials programme Jon Heywood Research Nurse x 26741/bleep 2852 Dr S Falk Angela Webb Research Nurse x 26753/bleep 2195 Paul Armenise Trial Coordinator x 26743 MRC (NIHR) Opening imminently STUDIES OPEN TO RECRUITMENT TRIAL No. STUDY DESCRIPTION P.I. CONTACT SPONSOR/ PORTFOLIO DATE OPENED GYNAE ON/3790 ICON 8 Location of trial treatment: CDU An international phase III randomised trial of dose-fractionated chemotherapy compared to standard three-weekly chemotherapy, following immediate primary surgery or as part of delayed primary surgery, for women with newly diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer Seonaid Wright Research Nurse x 26755/bleep 2459 Vicki Kitchker Research Nurse x 26744/bleep 3279 Dr H Booz Jon Heywood Research Nurse x 26741/bleep 2852 MRC (NIHR) 25/11/2011 Commercial (NIHR) 01/03/2013 Robert Hollister Trial Coordinator x 26742 Seonaid Wright Research Nurse x 26755/bleep 2459 ON/3925 DESKTOP III Location of trial treatment: CDU A randomised multicentre study to compare the efficacy of additional tumour debulking surgery versus chemotherapy alone for recurrent platinum-sensitive ovarian cancer Vicki Kitchker Research Nurse x 26744/bleep 3279 Dr J Murdoch Jon Heywood Research Nurse x 26741/bleep 2852 Robert Hollister Trial Coordinator x 26742 ON/4295 OSCAR 1 ON/4176 TRIOC An observational study of avastin® (bevacizumab) as first line therapy in patients with advanced ovarian cancer A Randomised Parallel Group Double-Blind Phase II Study to Assess the Activity of Trovax® (MVA-5T4) Versus Placebo in Patients with Relapsed Asymptomatic Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer Helen Boal Clinical Trials Officer x 26737/bleep 6342 Dr A Walther Robert Hollister Trial Coordinator x 26742 Commercial (NIHR) 02/08/2013 Vicki Kitchker Research Nurse x 26744/bleep 3279 Seonaid Wright Research Nurse x 26755/bleep 2459 Dr A Walther UCL (NIHR) Jon Heywood Research Nurse x 26741/bleep 2852 Robert Hollister Trial Coordinator x 26742 Opening imminently STUDIES OPEN TO RECRUITMENT TRIAL No. ON/2013/4463 BriTROC-1 STUDY DESCRIPTION The UK Translational Research in Ovarian Cancer Collaborative Sample collection study to investigate the role of Homologous Recombination Deficiency in platinum sensitivity in recurrent high grade serous ovarian cancer P.I. CONTACT SPONSOR/ PORTFOLIO DATE OPENED Seonaid Wright Research Nurse x 26755/bleep 2459 Vicki Kitchker Research Nurse x 26744/bleep 3279 Dr A Walther Jon Heywood Research Nurse x 26741/bleep 2852 NHS Greater Glasgow & Clyde (NIHR) Opening imminently Robert Hollister Trial Coordinator x 26742 HAEMATOLOGY CH/1799 Leukaemia Samples (594) ALL sample study Location of trial treatment: N/A blood study ON/3067 AML 17 1st line eCRF Location of trial treatment: Ward 62 and Haem Day Unit ON/3149 Cytarabine Sensitivity sample study Location of trial treatment: Sample study The use of allogeneic T-lymphocytes (CTL) in adults with acute leukaemia (The use of cytotoxic t-lymphocytes (CTCs) as adoptive immunotherapy in patients with acute lymphoblastic leukaemia after bone marrow transplant Working parties on leukaemia in adults and children trial in acute myeloid leukaemia or high risk myelodysplastic syndrome 17 Vicki Kitchker Research Nurse x 26744/bleep 3279 Dr J Bird Jon Heywood Research Nurse x 26741/bleep 2852 National Blood Service 01/03/2008 Lisa Mayne Trial Coordinator x 26746 Jon Heywood Research Nurse x 26741/bleep 2852 Dr P Mehta Vicki Kitchker Research Nurse x 26744/bleep 3279 Cardiff University 09/07/2009 (NIHR) Lisa Mayne Trial Coordinator x 26746 Vicki Kitchker Research Nurse x 26744/bleep 3279 Cytarabine Sensitivity Study - Bacterial Biosensors for rapid pre-screening of chemotherapy efficacy Dr P Mehta Jon Heywood Research Nurse x 26741/bleep 2852 Lisa Mayne Trial Coordinator x 26746 Frimley Park Hospital (NIHR) 18/12/2009 STUDIES OPEN TO RECRUITMENT TRIAL No. ON/3418 UKALL 14 1st line Location of trial treatment: Ward 62 and Haem Day Unit ON/3290 PASS eCRF Location of trial treatment: N/A ON/3368 MYELOMA XI 1st line Also recruiting at NBT Location of trial treatment: Outpatient oral chemotherapy and Haem Day Unit ON/3613 REVEAL 1st line Location of trial treatment: Haem Day Unit ON/3532 PNH Registry eCRF Location of trial treatment: Outpatients STUDY DESCRIPTION P.I. CONTACT SPONSOR/ PORTFOLIO DATE OPENED Vicki Kitchker Research Nurse x 26744/bleep 3279 A randomised trial for adults with newly diagnosed acute lymphoblastic leukaemia Prof D Marks Jon Heywood Research Nurse x 26741/bleep 2852 UCL (NIHR) 04/02/2011 Commercial 29/06/2010 CTRU Leeds (NIHR) 12/05/2011 UCL (NIHR) 13/04/2012 Lisa Mayne Trial Coordinator x 26746 A non-interventional observational post authorisation safety study of subjects treated with lenalidomide Randomised comparisons in myeloma patients of all ages of thalidomide, lenalidomide and bortezomib combinations, and maintenance lenalidomide Dr J Bird, x 21120 Dr J Bird jenny.bird@uhbristol.nhs.uk Call CTU on x 26733 Vicki Kitchker Research Nurse x 26744/bleep 3279 Dr J Bird Jon Heywood Research Nurse x 26741/bleep 2852 Emily Foulstone Trial Coordinator x 26738 Vicki Kitchker Research Nurse x 26744/bleep 3279 A Pilot Study of Relapsed or Refractory Patients Using Velcade (Bortezomib) Combination Chemotherapy in AL Amyloidosis Dr J Bird The Paroxysmal Nocturnal Haemoglobinuria (PNH) Registry (M07001) Dr P Mehta Jon Heywood Research Nurse x 26741/bleep 2852 Emily Foulstone Trial Coordinator x 26738 Helen Boal Clinical Trials Officer x 26737/bleep 6342 Lisa Mayne Trial Coordinator x 26746 Commercial (NIHR) 23/09/2011 STUDIES OPEN TO RECRUITMENT TRIAL No. ON/3722 LI-1 Location of trial treatment: Ward 62 and Haem Day Unit CH/3875 UKALL 2011 Location of trial treatment: Ward 62 and Haem Day Unit PA/2519 MDSBio Location of trial treatment: Haem Day Unit for BM / Outpatients STUDY DESCRIPTION A Programme of Development for older patients with Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome United Kingdom National Randomised Trial For Children and Young Adults with Acute Lymphoblastic Leukaemia and Lymphoma 2011 Molecular and functional characterisation of bone marrow function in normal subjects, myelodysplastic syndromes (MDS), acute myeloid leukaemia (AML) and secondary disorders of haematopoiesis P.I. CONTACT SPONSOR/ PORTFOLIO DATE OPENED Vicki Kitchker Research Nurse x 26744/bleep 3279 Dr P Mehta Jon Heywood Research Nurse x 26741/bleep 2852 Cardiff Uni / NIHR 23/03/2012 Lisa Mayne Trial Coordinator x 26746 John Moppett (BCH) Prof D Marks (BHOC Lead) Vicki Kitchker Research Nurse x 26744/bleep 3279 Jon Heywood Research Nurse x 26741/bleep 2852 Uni of Birmingham 06/06/2012 (NIHR) Lisa Mayne Trial Coordinator x 26746 Vicki Kitchker Research Nurse x 26744/bleep 3279 Dr P Mehta Jon Heywood Research Nurse x 26741/bleep 2852 (NIHR) 25/07/2012 UCL (NIHR) 12/11/2013 Lisa Mayne Trial Coordinator x 26746 Vicki Kitchker Research Nurse x 26744/bleep 3279 ON/4143 UKALL 60+ e-CRF Phase 2 study for older adults with Acute Lymphoblastic Leukaemia Prof D Marks Jon Heywood Research Nurse x 26741/bleep 2852 Lisa Mayne Trial Coordinator x 26746 ON/2014/4522 MUK5 A phase II randomised trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs cyclophosphamide, velcade and dexamethasone (CVD) for first relapse and primary refractory multiple myeloma Vicki Kitchker Research Nurse x 26744/bleep 3279 Dr J Bird Jon Heywood Research Nurse x 26741/bleep 2852 Emily Foulstone Trial Coordinator x 26738 Uni of Leeds (NIHR) Opening imminently STUDIES OPEN TO RECRUITMENT TRIAL No. ON/4265 AZA-MDS-003 e-CRF ON/4020 InoVATE (INOTUZUMA B) e-CRF Location of trial treatment: Haem Day Unit STUDY DESCRIPTION A Phase 3, Multicentre, Randomised, DoubleBlind 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 TransfusionDependent Anemia And Thrombocytopenia Due To IPSS LowerRisk Myelodysplastic Syndromes An Open-label, Randomised Phase 3 Study of Inotuzumab Ozogamicin Compared to a Defined Investigator’s Choice in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL) P.I. CONTACT SPONSOR/ PORTFOLIO DATE OPENED Vicki Kitchker Research Nurse x 26744/bleep 3279 Dr P Mehta Jon Heywood Research Nurse x 26741/bleep 2852 Commercial (NIHR) 17/10/2013 Lisa Mayne Trial Coordinator x 26746 Jon Heywood Research Nurse x 26741/bleep 2852 Prof D Marks Vicki Kitchker Research Nurse x 26744/bleep 3279 Lisa Mayne Trial Coordinator x 26746 Commercial (NIHR) 24/01/13 STUDIES OPEN TO RECRUITMENT TRIAL No. STUDY DESCRIPTION P.I. CONTACT SPONSOR/ PORTFOLIO DATE OPENED HEAD & NECK ON/3636 ART DECO Adjuvant Location of trial treatment: LG2 Radiotherapy: Ward 61 Chemotherapy ON/3803 IoN Location of trial treatment: Ward 61 Isotope treatment rooms A Randomised Multicentre Accelerated Radiotherapy Study of Dose Escalated Intensity Modulated Radiotherapy vs Standard Dose Intensity Modulated Radiotherapy in Patients Receiving Treatment for Locally Advanced Laryngeal and Hypopharyngeal Cancers (NIHR) Dorothy Griffiths Research Radiographer x 26739/bleep 3013 Dr M Beasely Dana Weston Research Radiographer x 26754/bleep 2436 Aintree University Hospitals NHS Foundation Trust (NIHR) 10/01/2011 UCL/NIHR 24/05/2012 University of Warwick (NIHR) 26/11/2012 Helen Saldanha Trial Coordinator x 26740 Dorothy Griffiths Research Radiographer x 26739/bleep 3013 Is ablative radio-iodine Necessary for low risk differentiated thyroid cancer patients Dr M Beasley Dana Weston Research Radiographer x 26754/bleep 2436 Helen Saldanha Trial Coordinator x 26740 ON/3957 DeESCALATE Location of trial treatment: Ward 61 De-ESCALaTE HPV Determination of Epidermal growth factor receptor-inhibitor (cetuximab) versus Standard Chemotherapy (cisplatin) early And Late Toxicity Events in Human Papillomavirus-positive oropharyngeal squamous cell carcinoma Stephen Lang Research Nurse x 26745/bleep 6225 Angela Webb Research Nurse x 26753/bleep 2195 Dr H Booz Dana Weston Research Radiographer x 26754/bleep 2436 Emily Foulstone Trial Coordinator x 26738 STUDIES OPEN TO RECRUITMENT TRIAL No. STUDY DESCRIPTION P.I. CONTACT SPONSOR/ PORTFOLIO DATE OPENED Stephen Lang Research Nurse x 26745/bleep 6225 ON/3552 HOPON Location of trial treatment: Hyperbaric oxygen treatment to be administered either in Cariff or Plymouth hospitals HOPON (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis): A Randomised Controlled Trial of Hyperbaric Oxygen to prevent Osteoradionecrosis of the Irradiated Mandible Angela Webb Research Nurse x 26753/bleep 2195 Dr M Beasley Dana Weston Research Radiographer x 26754/bleep 2436 Uni of Liverpool / Aintree Uni (NIHR) 30/11/2012 MRC (NIHR) 12/02/2007 Emily Foulstone Trial Coordinator x 26738 LUNG ON/2490 QUARTZ (522) Metastatic Location of trial treatment: LG2 radiotherapy. ON/3848 SMART Location of trial treatment: LG2 Radiotherapy A phase 111 multicentre randomised controlled trial to assess whether optimal supportive care alone (including Dexamethasone) is as effective as optimal supportive care (including Dexamethasone) plus whole brain radiotherapy in the treatment of patients with inoperable brain metastases from non small cell lung cancer. Surgical and large bore pleural procedures in malignant pleural Mesothelioma And Radiotherapy Trial (SMART trial) - RCT evaluating whether prophylactic radiotherapy reduces the incidence of procedure tract metastases Dorothy Griffiths Research Radiographer x 26739/bleep 3013 Dr C Comins Dana Weston Research Radiographer x 26754/bleep 2436 Helen Saldanha Trial Coordinator x 26740 Dorothy Griffiths Research Radiographer x 26739/bleep 3013 Dr C Comins Dana Weston Research Radiographer x 26754/bleep 2436 Helen Saldanha Trial Coordinator x 26740 NBT / NIHR 03/01/12 STUDIES OPEN TO RECRUITMENT TRIAL No. STUDY DESCRIPTION ON/4267 LungART Phase III study comparing postoperative conformal radiotherapy to no post-operative radiotherapy in patients with completely resected non-small cell lung cancer and mediastinal N2 Involvement P.I. CONTACT PORTFOLIO DATE OPENED NIHR 28/10/2013 Commercial 17/09/2013 Leeds Teaching Hospital (NIHR) 13/01/2009 NIHR 23/05/2013 SPONSOR/ Dorothy Griffiths Research Radiographer x 26739/bleep 3013 Dr C Comins Dana Weston Research Radiographer x 26754/bleep 2436 Helen Saldanha Trial Coordinator x 26740 LYMPHOMA ON/4195 ZEST A Phase 3, Openlabel, Multicentre, Randomised Study of Sequential Zevalin (ibritumomab tiuxetan) versus Observation in Patients at Least 60 Years of Age with Newly Diagnosed Diffuse Large B-cell Lymphoma in PETnegative Complete Remission After RCHOP or R-CHOP-like Therapy Dorothy Griffiths Research Radiographer x 26739/bleep 3013 Dr M Beasley Dana Weston Research Radiographer x 26754/bleep 2436 Helen Saldanha Trial Coordinator x 26740 MELANOMA/SKIN ON/2815 Melanoma Lifestyle Study The melanoma lifestyle study Dr D de Berker Helen Boal Clinical Trials Officer x 26737/bleep 6342 Location of trial treatment: N/A sample study ON/4205 IMAGE A multi-national, prospective, observational study in patients with unresectable or metastatic melanoma, using Yervoy (ipilimumab) Helen Boal Clinical Trials Officer x 26737/bleep 6342 Dr C Herbert Paul Armenise Trial Coordinator x 26743 STUDIES OPEN TO RECRUITMENT TRIAL No. STUDY DESCRIPTION ON/4242 BRIM8 – GO27826 A phase III, randomized, doubleblind, placebo controlled study of vemurafenib (RO5185426) adjuvant therapy in patients with surgically resected, cutaneous BRAFmutant melanoma at high risk for recurrence ON/4291 ZeSS A Prospective Observational Safety Study of Patients with BRAFV600 Mutationpositive Unresectable or Metastatic Melanoma Treated with Vemurafenib (Zelboraf®) ON/2013/4344 NEMO A randomized Phase III, open label, multicenter, two-arm study comparing the efficacy of MEK162 versus Dacarbazine in patients with advanced unresectable or metastatic NRAS mutation positive melanoma P.I. CONTACT PORTFOLIO DATE OPENED Commercial 29/07/2013 Commercial 05/07/2013 SPONSOR/ Stephen Lang Research Nurse x 26745/bleep 6225 Dr C Herbert Vicki Kitchker Research Nurse x 26744/bleep 3279 Paul Armenise Trial Coordinator x 26743 Helen Boal Clinical Trials Officer x 26737/bleep 6342 Dr C Herbert Paul Armenise Trial Coordinator x 26743 Stephen Lang Research Nurse x 26745/bleep 6225 Dr C Herbert Vicki Kitchker Research Nurse x 26744/bleep 3279 18/03/2014 Commercial Paul Armenise Trial Coordinator x 26743 PALLIATIVE Dana Weston Research Radiographer x 26754/bleep 2436 A Randomised phase III trial of single fraction radiotherapy compared to multifraction radiotherapy in patients with metastatic spinal cord compression Dr K Hopkins SU/2013/4332 TREC Transanal Endoscopic Microsurgery (TEM) and Radiotherapy in Early Rectal Cancer Mr M Thomas Rebecca Houlihan Surgical Research Nurse, BRI x 24551/bleep 6304 ON/2013/4264 ROCS Radiotherapy after Oesophageal Cancer Stenting Study Prof J Blazeby Katrina Hurley Snr Research Nurse Surgical Research Team x 204532 ON/3347 SCORAD III Metastatic Location of trial treatment: LG2 Radiotherapy Dorothy Griffiths Research Radiographer x 26739/bleep 3013 UCL (NIHR) 15/07/2010 Helen Saldanha Trial Coordinator x 26740 Uni of Birmingham 26/09/2013 (NIHR) Velindre NHS Trust (NIHR) In set-up STUDIES OPEN TO RECRUITMENT TRIAL No. STUDY DESCRIPTION P.I. CONTACT SPONSOR/ PORTFOLIO DATE OPENED SARCOMA ON/3590 Axi STS 2nd & 3rd line Location of trial treatment: Home ON/3696 CASPS Metastatic Location of trial treatment: Home ON/3947 STRASS Location of trial treatment: LG2 Radiotherapy A clinicopathological phase II study of axitinib in patients with advanced angiosarcoma and other soft tissue sarcomas Stephen Lang Research Nurse x 26745/bleep 6225 Dr A Dangoor Liz Allison Research Nurse x 26736/bleep 2999 Robert Hollister Trial Coordinator x 26742 Sheffield teaching hospitals NHS Foundation Trust (NIHR) 09/05/2011 ICR/Royal Marsden (NIHR) 26/09/2011 EORTC (NIHR) 12/11/2012 Stephen Lang Research Nurse x 26745/bleep 6225 A phase II trial of Cediranib in the treatment of patients with alveolar soft part sarcoma Dr A Dangoor Liz Allison Research Nurse x 26736/bleep 2999 Robert Hollister Trial Coordinator x 26742 A phase III randomised study of preoperative radiotherapy plus surgery versus surgery alone for patients with Retroperitoneal sarcoma (RPS) Dana Weston Research Radiographer x 26754/bleep 2436 Dr P Cornes Dorothy Griffiths Research Radiographer x 26739/bleep 3013 Helen Saldanha Trial Coordinator x 26740 CH/3909 VIT 09-10 International randomised phase II trial of the combination of vincristine and irinotecan with or withour temozolomide (VI or VIT) in children and adults with refractory or relapsed rhabdomyosarcoma Stephen Lang Research Nurse x 26745/bleep 6225 Dr H Rees TEENAGERS & YOUNG ADULTS Liz Allison Research Nurse x 26736/bleep 2999 Robert Hollister Trial Coordinator x 26742 Commercial (NIHR) 19/08/2013 (BHOC) STUDIES OPEN TO RECRUITMENT TRIAL No. ON/4044 BRIGHTLIGHT Location of trial treatment: N/A non-chemo trial STUDY DESCRIPTION The 2012 TYA Cancer Cohort Study (the BRIGHTLIGHT Study). Do specialist cancer services for teenagers and young adults (TYA) add value? P.I. Dr A Cameron CONTACT Vicki Kitchker Research Nurse x 26744/bleep 3279 Sylvia Pearson SPONSOR/ PORTFOLIO DATE OPENED UCL (NIHR) 12/11/2012 ICR (NIHR) 23/04/2007 MRC (NIHR) 06/08/2008 ICR (NIHR) 15/10/2010 Uni of Warwick (NIHR) 31/10/2013 Snr Trial Coordinator x 26747 TESTICULAR ON/2537 Testicular Genetics Location of trial treatment: Genetics trial so no treatment given ON/2826 TRISST (TE24) (585) Imaging Identification of testicular germ cell tumour susceptibility genes- the UK Genetics of testicular genetics study Dr J Braybrooke Liz Allison Research Nurse x 26736/bleep 2999 Trial Of Imaging and Schedule in Seminoma Testes Dr J Braybrooke Location of trial treatment: Imaging trial so no treatment given ON/3452 111 TRIAL Adjuvant Location of trial treatment: Days 13 treatment given on Ward 61; Days 8 & 15 treatment given on CDU Helen Boal Clinical Trials Officer x 26737/bleep 6342 A single group trial evaluating one cycle of adjuvant BEP chemotherapy in high risk, stage 1 nonseminomatous germ cell tumours of the testis (NSGCTT) Angela Webb Research Nurse x 26753/bleep 2195 Helen Boal Clinical Trials Officer x 26737/bleep 6342 Liz Allison Research Nurse x 26736/bleep 2999 Dr J Braybrooke Angela Webb Research Nurse x 26753/bleep 2195 Helen Boal Clinical Trials Officer x 26737/bleep 6342 UNSPECIFIED ON/4310 SELECT-D e-CRF Anticoagulation Therapy in SELECTeD Cancer Patients at Risk of Recurrence of Venous Thromboembolism Stephen Lang Research Nurse x 26745/bleep 6225 Dr A Kuchel Angela Webb Research Nurse x 26753/bleep 2195 Lisa Mayne Trial Coordinator x 26746 STUDIES OPEN TO RECRUITMENT TRIAL No. STUDY DESCRIPTION P.I. CONTACT PORTFOLIO DATE OPENED Southampton Uni 26/05/2007 SPONSOR/ UPPER GI Angela Webb Research Nurse x 26753/bleep 2195 ON/2513 BILCAP (533) Adjuvant Location of trial treatment: Oral chemotherapy dispensed A randomised clinical trial evaluating adjuvant chemotherapy with capecitabine compared to expectant treatment alone following surgery for biliary tract cancer Sharon Short Research Nurse x 26751/bleep 3463 Dr S Falk Seonaid Wright Research Nurse x 26755/bleep 2459 (NIHR) Emily Foulstone Trial Coordinator x 26738 Sharon Short Research Nurse x 26751/bleep 3463 ON/2646 ST03 (553) neo adjuvant Location of trial treatment: Ward 61 A randomised phase II/III trial of perioperative chemotherapy with or without bevacizumab in operable adenocarcinoma of the stomach and GO junction Angela Webb Research Nurse x 26753/bleep 2195 Dr S Falk Seonaid Wright Research Nurse x 26755/bleep 2459 MRC (NIHR) 27/08/2008 Emily Foulstone Trial Coordinator x 26738 Sharon Short Research Nurse x 26751/bleep 3463 ON/2844 ESPAC-4 Adjuvant Location of trial treatment: CDU Combination versus single agent chemotherapy in resectable pancreatic cancer. European Study Group for PAncreatic Cancer Trial 4 Angela Webb Research Nurse x 26753/bleep 2195 Dr S Falk Seonaid Wright Research Nurse x 26755/bleep 2459 Emily Foulstone Trial Coordinator x 26738 Uni of Liverpool (NIHR) 09/04/2009 STUDIES OPEN TO RECRUITMENT TRIAL No. ON/4097 MetMAb Location of trial treatment: CDU ON/3953 GATSBY NCRN369 Location of trial treatment: 1st treatment of TDm-1 administered on Ward 61; subsequently administered on CDU ON/4212 ChOPIN ON/4241 RESORCE Location of trial treatment: Oral treatment dispensed STUDY DESCRIPTION A Randomised, Phase III, Multicentre, Double-Blind, PlaceboControlled Study Evaluating the Efficacy and Safety of Onartuzumab (Metmab) In Combination With 5Fluorouracil, Folinic Acid, And Oxaliplatin (Mfolfox6) In Patients With Metastatic Her2Negative Met-Positive GO Cancer A Randomised, Multicentre, Adaptive Phase II/III Study To Evaluate The Efficacy And Safety Of Trastuzumab Emtansine (T-Dm1) Versus Taxane (Docetaxel Or Paclitaxel) In Patients With Previously Treated Locally Advanced Or Metastatic Her2Positive Gastric Cancer, Including Adenocarcinoma Of The GO Junction Chemoprevention Of Premalignant Intestinal Neoplasia (ChOPIN) incorporating Inherited Predisposition of Oesophageal Diseases (IPOD) A randomised, double blind, placebocontrolled, multicenter phase III study of regorafenib in patients with hepatocellular carcinoma (HCC) after sorafenib P.I. CONTACT SPONSOR/ PORTFOLIO DATE OPENED Sharon Short Research Nurse x 26751/bleep 3463 Angela Webb Research Nurse x 26753/bleep 2195 Dr S J Falk Seonaid Wright Research Nurse x 26755/bleep 2459 Commercial (NIHR) 28/01/2013 Emily Foulstone Trial Coordinator x 26738 Angela Webb Research Nurse x 26753/bleep 2195 Sharon Short Research Nurse x 26751/bleep 3463 Dr S J Falk Seonaid Wright Research Nurse x 26755/bleep 2459 Commercial (NIHR) 11/12/2012 Emily Foulstone Trial Coordinator x 26738 Helen Boal Clinical Trials Officer x 26737/bleep 6342 Dr S J Falk Emily Foulstone Trial Coordinator x 26738 Angela Webb Research Nurse x 26753/bleep 2195 QMUL (NIHR) 09/05/2013 Commercial 17/07/2013 Sharon Short Research Nurse x 26751/bleep 3463 Dr S J Falk Seonaid Wright Research Nurse x 26755/bleep 2459 Emily Foulstone Trial Coordinator x 26738 STUDIES OPEN TO RECRUITMENT TRIAL No. ON/4210 NeoSCOPE Location of trial treatment: CDU and radiotherapy STUDY DESCRIPTION Neoadjuvant - Study of Chemoradiotherapy in OesoPhagEal Cancer A randomised Phase II study of two preoperative chemoradiotherapy regimes (oxaliplatin and capecitabine followed by radiotherapy with either oxaliplatin and capecitabine or paclitaxel and carboplatin) for resectable oesophageal cancer. P.I. CONTACT SPONSOR/ PORTFOLIO DATE OPENED Angela Webb Research Nurse x 26753/bleep 2195 Sharon Short Research Nurse x 26751/bleep 3463 Dr S J Falk Seonaid Wright Research Nurse x 26755/bleep 2459 Velindre NHS Trust (NIHR) 16/09/2013 Emily Foulstone Trial Coordinator x 26738 Angela Webb Research Nurse x 26753/bleep 2195 ON/2013/4398 GO2 Alternative chemotherapy for frail or elderly patients with advanced gastric or oesophageal cancer Sharon Short Research Nurse x 26751/bleep 3463 Dr S Falk Seonaid Wright Research Nurse x 26755/bleep 2459 Uni of Leeds (NIHR) Open 18/03/2014 Emily Foulstone Trial Coordinator x 26738 UROLOGY Stephen Lang Research Nurse x 26745/bleep 6225 ON/2475 STAMPEDE Metastatic Location of trial treatment: CDU or oral Systemic Therapy in Advancing or Metastatic Prostate Cancer; Evaluation of Drug Efficacy Seonaid Wright Research Nurse x 26755/bleep 2459 Dr A Bahl Sharon Short Research Nurse x 26751/bleep 3463 MRC (NIHR) 29/10/2007 CRUK (NIHR) 12/02/2007 Kimberly Rockley Trial Coordinator x 26748 ON/2411 RAPPER Location of trial treatment: N/A Blood study Radiogenomics: Assessment of polymorphisms for predicting the effects of radiotherapy (Prostate) Dr A Bahl Helen Boal Clinical Trials Officer x 26737/bleep 6342 STUDIES OPEN TO RECRUITMENT TRIAL No. STUDY DESCRIPTION P.I. Also open at NBT Location of trial treatment: LG2 Radiotherapy or N/A for hormone therapy ON/3504 SORMET (FLT-PET/CT) Metastatic Location of trial treatment: N/A Radiotherapy and androgen deprivation in combination after local surgery: a randomised controlled trial in prostate cancer SPONSOR/ PORTFOLIO DATE OPENED Dorothy Griffiths Research Radiographer x 26739/bleep 3013 ON/2703 RADICALS adjuvant CONTACT Dr A Bahl Dana Weston Research Radiographer x 26754/bleep 2436 MRC (NIHR) 24/07/2008 Investigator led 25/02/2011 EORTC / NIHR 14/03/2012 CRUK/NIHR 22/08/2012 Helen Saldanha Trial Coordinator x 26740 Prediction of clinical benefit from sorafenib in metastatic renal cell cancer using FLTPET/CT Dr J Kabala Dr J Kabala Seonaid Wright Research Nurse x 26755/bleep 2459 ON/3767 SURTIME Location of trial treatment: Oral Randomised phase III trial comparing immediate versus deferred nephrectomy in patients with synchronous metastatic renal cell carcinoma Sharon Short Research Nurse x 26751/bleep 3463 Dr A Bahl Stephen Lang Research Nurse x 26745/bleep 6225 Kimberly Rockley Trial Coordinator x 26748 ON/3902 PLUTO Location of trial treatment: CDU or oral A randomised phase II study investigating pazopanib vs weekly paclitaxel in relapsed or progressive transitional cell carcinoma (tcc) of the urothelium (PLUTO): A randomised phase ii study investigating pazopanib vs weekly paclitax Sharon Short Research Nurse x 26751/bleep 3463 Seonaid Wright Research Nurse x 26755/bleep 2459 Dr A Bahl Stephen Lang Research Nurse x 26745/bleep 6225 Helen Boal Clinical Trials Officer x 26737/bleep 6342 STUDIES OPEN TO RECRUITMENT TRIAL No. STUDY DESCRIPTION P.I. CONTACT PORTFOLIO DATE OPENED Investigator led 02/05/2012 University of Birmingham (NIHR) 15/11/2012 ICR (NIHR) 18/12/12 SPONSOR/ Seonaid Wright Research Nurse x 26755/bleep 2459 ON/3775 BRISTOL BLADDER TRIAL Location of trial treatment: Ward 61 Bristol Bladder trial: A phase II trial of combination Cabazitaxel + Cisplatin in the Neo-adjuvant treatment of transitional cell carcinoma of the Urinary bladder Sharon Short Research Nurse x 26751/bleep 3463 Dr A Bahl Stephen Lang Research Nurse x 26745/bleep 6225 Sylvia Pearson Snr Trial Coordinator x 26747 Sharon Short Research Nurse x 26751/bleep 3463 ON/4013 PAz02 Location of trial treatment: Oral A study of pazopanib efficacy and safety in patients with advanced clear cell renal cell carcinoma and ECOG Performance Status 2 (PaZ02) Seonaid Wright Research Nurse x 26755/bleep 2459 Dr A Bahl Stephen Lang Research Nurse x 26745/bleep 6225 Kimberly Rockley Trial Coordinator x 26748 Seonaid Wright Research Nurse x 26755/bleep 2459 ON/4056 POUT Location of trial treatment: Ward 61 A phase III randomised trial of peri-operative chemotherapy versus surveillance in upper tract urothelial cancer Sharon Short Research Nurse x 26751/bleep 3463 Dr A Bahl Stephen Lang Research Nurse x 26745/bleep 6225 Helen Boal Clinical Trials Officer x 26737/bleep 6342 STUDIES OPEN TO RECRUITMENT TRIAL No. STUDY DESCRIPTION P.I. CONTACT SPONSOR/ PORTFOLIO DATE OPENED Sharon Short Research Nurse x 26751/bleep 3463 ON/4053 A-PREDICT ON/4318 PROMPTS ON/4262 PROSTVAC A Phase II Study of Axitinib in Patients with Metastatic Renal Cell Cancer Unsuitable for Nephrectomy A prospective randomised phase III study of observation vs screening MRI and pre-emptive treatment in castrate resistant prostate cancer patients with spinal metastases A randomised, double blind, phase III efficacy trial of Prostvac V/F+/GM-CSF in men with asymptomatic or minimally symptomatic metastatic, castrate resistant prostate cancer Seonaid Wright Research Nurse x 26755/bleep 2459 Dr A Bahl Stephen Lang Research Nurse x 26745/bleep 6225 Commercial (NIHR) 22/11/2013 Kimberly Rockley Trial Coordinator x 26748 Dorothy Griffiths Research Radiographer x 26739/bleep 3013 Dr A Bahl Dana Weston Research Radiographer x 26754/bleep 2436 ICR (NIHR) 29/11/2013 Commercial 19/12/2013 The University of Glasgow and NHS Greater Glasgow and Clyde (NIHR) 11/03/2014 Kimberly Rockley Trial Coordinator x 26748 Seonaid Wright Research Nurse x 26755/bleep 2459 Sharon Short Research Nurse x 26751/bleep 3463 Dr A Bahl Stephen Lang Research Nurse x 26745/bleep 6225 Sylvia Pearson Snr Trial Coordinator x 26747 ON/3855 SAPROCAN Saracatanib (AZD0530) and docetaxel in metastatic, castrate refractory prostate cancer A phase I/randomised phase II study by the UK NCRI prostate clinical studies group. Seonaid Wright Research Nurse x 26755/bleep 2459 Sharon Short Research Nurse x 26751/bleep 3463 Dr A Bahl Stephen Lang Research Nurse x 26745/bleep 6225 Kimberly Rockley Trial Coordinator x 26748 STUDIES OPEN TO RECRUITMENT TRIAL No. ON/4482 ZEBRA STUDY DESCRIPTION An open label, randomised, phase II study comparing AZD2014 versus EVEROLIMUS in patients with advanced metastatic renal cancer and progression on VEGF Targeted therapy (NIHR) P.I. CONTACT PORTFOLIO DATE OPENED (NIHR) 27/03/2014 SPONSOR/ Seonaid Wright Research Nurse x 26755/bleep 2459 Sharon Short Research Nurse x 26751/bleep 3463 Dr A Bahl Stephen Lang Research Nurse x 26745/bleep 6225 Kimberly Rockley Trial Coordinator x 26748 STUDIES IN SET-UP TRIAL No. STUDY TITLE P.I. SPONSOR/ PORTFOLIO BMT A Randomised Trial of the FLAMSA-BU CondItioning ReGimen in Patients with Acute Myeloid Leukaemia and Myelodysplasia UndeRgoing AllOgeneic Stem Cell Transplantation DM Uni of B’ham (NIHR) A two part study to assess the tolerability, safety and pharmacodynamics of Sativex in combination with dose-intense Temozolomide in patients with recurrent glioblastoma KIH Commercial ON/2013/4234 CONCEPT A randomised phase II pilot study of 3 weekly Cabazitaxel versus weekly Paclitaxel chemotherapy in the first line treatment of HER2 negative metastatic breast cancer AKB BHOC/UHB led study ON/2014/4528 M14-011 A Randomised, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects with Early Stage Triple Negative Breast Cancer (TNBC) CGP Commercial An International Multicentre Open Label Randomised Phase II Advanced Anal Cancer Trial Comparing Cisplatin plus 5-fluorouracil versus Carboplatin plus Weekly Paclitaxel in Patients with Inoperable Locally Recurrent or Metastatic Disease SJF NIHR ON/2009/3167 WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study (WT1 TCR-001). SR UCL (NIHR) ON/2010/3573 FCLL Currently on hold Genetic study of chronic lymphocytic leukaemia and other lymphoproliferative disease RSE ICR (NIHR) DM Commercial RR Commercial PM NIHR ON/2013/4341 FIGARO BRAIN ON/2014/4521 SATIVEX BREAST COLORECTAL ON/2014/4498 InterAACT HAEMATOLOGY A Phase 3, Randomized, Open Label Study ON/2013/4413 TOWER ON/2014/4533 GO28667 ON/2013/4465 AML18 Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) A multicentre, phase iii, open-label, randomized study in relapsed/refractory patients with chronic lymphocytic leukaemia to evaluate the benefit of gdc0199 (abt-199) plus rituximab compared with bendamustine plus rituximab A trial for older patients with acute myeloid leukaemia and high risk myelodysplastic syndrome STUDIES IN SET-UP TRIAL No. STUDY TITLE P.I. SPONSOR/ PORTFOLIO LUNG ON/2013/4488 STOMP ON/2014/4506 RESPECT-MESO Currently on hold Small cell lung cancer Trial of Olaparib (AZD2281) as Maintenance Programme: a randomised, double blind, multicentre phase II trial A multi-centre non-blinded randomised controlled trial to assess the impact of regular early specialist symptom control treatment on quality of life in malignant mesothelioma AD NIHR PCW Commercial SJF Commercial SJF Cambridge University Hospitals NHS Trust (NIHR) UPPER GI ON/2013/4435 COAST – BAY 73-4506 15983 ON/2013/4429 SIEGE A Randomized, Double-blind, Placebo-controlled Phase-III Study of Adjuvant Regorafenib Versus Placebo for Patients with Stage IV Colorectal Cancer After Curative Treatment of Liver Metastases (Scheduling nab-paclitaxel with gemcitabine): Randomised phase II trial to investigate two different schedules of nab-paclitaxel (Abraxane) combined with gemcitabine as first line treatment for metastatic pancreatic ductal adenocarcinoma UROLOGY ON/2013/4233 JAVA-P A Phase II Trial of Cabazitaxel Chemotherapy in Relapsed Locally Advanced & metastatic Carcinoma of the Penis AKB BHOC/UHB led study ON/2014/4559 PROSPER A Multinational, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Enzalutamide in Patients With non metastatic Castration-Resistant Prostate Cancer AKB Commercial