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1 14/LO/ RE-AKT: A randomised Phase II study of enzalutamide (MDV3100) in combination with AZD5363 in s with Metastatic Castration - Resistant Prostate Cancer Yes 08/01/ /07/ /07/ /06/ /09/ /09/ /10/2017 Delay due to the allocation of Nurse 14/LO/ /LO/ /NW/ /LO/ /NE/ /NW/ /NE/ A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination with Ramucirumab or Placebo in Previously Untreated s with EGFR Mutation-Positive Metastatic n-small Cell Lung Cancer 23/03/ /04/ /05/ /04/ /05/ /05/2017 Awaiting competing study to close before this study could open, this was mutually agreed with the Sponsor, but the competing study recruitment was unexpectedly slow. STUDY NOW CLOSED CA209-9TW BMS Melanoma 1L Chart Review Study Yes 16/03/ /09/ /09/ /09/ /12/ /12/ /12/2017 Sponsor queries in financial negotiations. Sponsor CaboGIST (EORTC 1317): Phase II study of cabozantinib in patients with metastatic gastrointestinal stromal tumor (GIST) who progressed during neoadjuvant, adjuvant or palliative therapy with imatinib and sunitinib. PIVOTAL BOOST: A phase III randomised controlled trial of prostate and pelvis versus prostate alone radiotherapy with or without prostate boost KEYNOTE 629: A Phase 2, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab in Participants with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cscc) PS2: A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB COMPARED WITH CHEMOTHERAPY IN PATIENTS WITH TREATMENT- NA?VE ADVANCED OR RECURRENT (STAGE IIIB NOT AMENABLE FOR MULTIMODALITY TREATMENT) OR METASTATIC (STAGE IV) NON-SMALL CELL LUNG CANCER WHO ARE DEEMED UNSUITABLE FOR PLATINUM-CONTAINING THERAPY Yes 22/01/ /05/ /06/ /07/ /11/ /11/ /12/2017 Queries over patient pathway and funding queries. Yes 04/01/ /08/ /08/ /07/ /12/ /12/ /01/2018 RTTQA delays in planning and 19/07/ /07/ /08/ /12/ /12/ /02/2018 Sponsor delay - considerable sponsor contract and costing delays 24/05/ /07/ /09/ /01/ /01/ /02/2018 Sponsor delays - awaiting submission of substantial amendment plus costing queries Respiratory Distress Symptom Intervention (RDSI) 22/09/ /10/ /06/ /01/ /01/ /02/2018 Sponsor delay - sponsor took some time to greenlight Sponsor CCC as a site TIDAL: Risk-stratified sequential Treatment with 07/12/ /12/ /09/ /02/ /01/ /02/2018 Ibrutinib and Rituximab (IR) and IR-CHOP for De-novo post-transplant Lymphoproliferative disorder (PTLD) Sponsor Sponsor 17/EM/ /EE/ REALISM UK: Retrospective real world evidence to review the current treatment pathways for myelofibrosis from across the UK BOSTON: A Phase 3 Randomized, Controlled, Open- Label Study of Selinexor, Bortezomib, and Dexamethasone (SVD) Versus Bortezomib and Dexamethasone (VD) in s with Relapsed or Refractory Multiple Myeloma (RRMM) 15/11/ /02/ /11/ /02/ /02/ /02/ /10/ /03/ /07/ /02/ /03/ /03/2018
2 18/EM/ /LO/ /EM/ /NW/ /SC/ /LO/ /YH/ /LO/ /LO/ /LO/ AMG : An Observational Study of Blinatumomab Safety and Effectiveness, Utilisation, and Treatment Practices 14/12/ /12/ /01/ /02/ /02/ /03/2018 TRITON 2: A Multicenter, Open-label Phase 2 Study of 31/05/ /05/ /03/ /02/ /02/ /03/2018 complex financial and contract negotiations, internal Rucaparib in s with Metastatic Castrationresistant capacity issues to support Prostate Cancer Associated with Homologous Recombination Deficiency TRITON 3: A Multicenter, Randomized, Open-label 31/05/ /05/ /06/ /02/ /02/ /03/2018 complex financial and contract negotiations, internal Phase 3 Study of Rucaparib versus Physician?s Choice capacity issues to support of Therapy for s with Metastatic Castrationresistant Prostate Cancer Associated with Homologous Recombination Deficiency CA209-8A7: Early access to medicines scheme? 12/03/ /03/ /12/ /03/ /03/ /03/2018 Nivolumab? for gastric and Gastroesophageal Junction (GC/GEJ) Adenocarcinoma Observational Study JAVELIN H&N (B ): A RANDOMIZED DOUBLE- 01/11/ /11/ /07/ /02/ /02/ /03/2018 complex financial and contract negotiations, internal BLIND PHASE 3 STUDY OF AVELUMAB IN capacity issues, delays in RTQA COMBINATION WITH STANDARD OF CARE CHEMORADIOTHERAPY (CISPLATIN PLUS DEFINITIVE RADIATION THERAPY) VERSUS STANDARD OF CARE CHEMORADIOTHERAPY IN THE FRONT LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK IMCGP : A PHASE II RANDOMIZED, OPEN- 26/06/ /06/ /11/ /02/ /02/ /03/2018 Costing queries, internal capacity issues & subcontract LABEL, MULTI-CENTER STUDY OF THE SAFETY AND delays from partner Trust EFFICACY OF IMCGP100 COMPARED WITH INVESTIGATOR?S CHOICE IN HLA-A*0201 POSITIVE PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED UVEAL MELANOMA PLATO - PersonaLising Anal cancer radiotherapy dose 03/04/ /04/ /07/ /03/ /02/2018 setrttqa delays in planning and Phase?III?randomised?trial?of?immunomodulatory?th erapy?in?high?risk?solitary?bone?plasmacytoma 07/06/ /06/ /08/2016 RTTQA delays in planning and LUCY - Lynparza Breast Cancer Real-World Utility, Clinical Effectiveness and Safety Study A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-ve Metastatic Breast Cancer s with Germline BRCA1/2 Mutations 31/08/ /08/2017 Awaiting patient pathway confirmation from PI Optimal Personalised Treatment of early breast cancer using Multiparameter Analysis 07/09/ /09/ /08/2016 Awaiting study documentation from internal service departments
3 17/NW/ /NW/ /LO/ /NW/ /LO/ /LO/ /EE/ PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, RANDOMIZED STUDY OF PRACINOSTAT IN COMBINATION WITH AZACITIDINE IN PATIENTS =18 YEARS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA UNFIT FOR STANDARD INDUCTION CHEMOTHERAPY A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previouslytreated Subjects with nresectable or Metastatic Cholangiocarcinoma with an IDH1 Mutation Renal Adjuvant MultiPle Arm Randomised Trial (RAMPART): An international investigator-led phase III multi-arm multi-stage multi-centre randomisedcontrolled platform trial of adjuvant therapy in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse. PETReA: Phase 3 evaluation of PET-guided, Response- Adapted therapy in patients with previously untreated, high tumour burden follicular lymphoma A multi-centre, open-label, randomized clinical trial comparing the efficacy and safety of the antibodydrug conjugate SYD985 to physician's choice in patients with HER2-positive unresectable locally advanced or metastatic breast cancer A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB* (MSB C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE IN PATIENTS WHO COMPLETED FIRST-LINE CHEMOTHERAPY FOR UNRESECTABLE LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) versus Treatment Choice in Adults with Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) Previously Treated with Hypomethylating Agents A phase Ib/IIa, randomised, double blind, parallel group, placebo controlled, multicentre study to assess the safety and efficacy of Cx611 expanded allogeneic adipose-derived stem cells (eascs) for the intravenous treatment of adult patients with a severe communityacquired bacterial pneumonia and admitted to the intensive care unit. SEPCELL study. 01/07/ /09/ /09/ /09/ /09/ /11/ /11/ /10/ /11/ /11/ /11/ /11/ /11/ /11/ /09/ /11/ /12/ /06/ /12/ /12/2017 Sub-contract delays from partner Trust Internal capacity issues by support service: complicated contract & financial negotiations Awaiting PI confirmation of capacity to conduct study Awaiting patient pathway confirmation from PI Internal capacity issues by support service: ARSAC delays (new process)
4 /SC/ /SC/ /EM/ /SC/ /NW/ /NE/ /LO/ Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX- Sponsored Clinical Trials A phase III, multicenter, randomized, double blind, placebo controlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v. 8 II- IIIA and IIIB (T>5cm N2) completely resected (R0) nonsmall cell lung cancer(nsclc) National?Lung?Matrix?Trial:?Multi-?drug,?genetic?marker-directed, non?-comparative, multi-?centre, multi?-arm phase II trial in non-small cell lung cancer A phase 3, multi-center, open-label, randomized study of oral ABL001 versus bosutinib in patients with Chronic Myelogenous Leukemia in chronic phase (CML- CP), previously treated with 2 or more tyrosine kinase inhibitors Evaluation of a n-endoscopic Immunocytological Device (Cytosponge) for post chemo-radiotherapy surveillance in patients with oesophageal cancer? a feasibility study A randomized double blind placebo controlled Phase II clinical trial of Cediranib and Olaparib maintenance in advanced recurrent Cervical Cancer. A RANDOMIZED, DOUBLE-BLIND PHASE 1B/2 STUDY OF PF IN COMBINATION WITH AZACITIDINE IN PATIENTS WITH PREVIOUSLY UNTREATED INTERMEDIATE-2 OR HIGH-RISK MYELODYSPLASTIC SYNDROME, ACUTE MYELOID LEUKEMIA WITH 20-30% BLASTS AND MULTI-LINEAGE DYSPLASIA, OR CHRONIC MYELOMONOCYTIC LEUKEMIA A randomized, open label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY ) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy 08/01/ /01/ /12/ /01/ /01/ /01/ /07/ /07/ /01/ /12/ /01/ /01/ /01/ /01/ /02/ /02/ /03/ /02/ /02/2018 Internal capacity issues by support service Complicated patient pathway and change over of nursing staff
5 18/NW/ /YH/ /WA/ /LO/ /SC/ A multi-centre, randomised, parallel group, openlabel, phase II, single-stage selection trial of nanoliposomal irinotecan (nal-iri) and 5-fluorouracil (5- FU)/folinic acid or docetaxel as second-line therapy in patients with progressive poorly differentiated extrapulmonary neuroendocrine carcinoma (NEC) A randomised phase II trial of nivolumab in combination with alternatively scheduled ipilimumab in first-line treatment of patients with advanced or metastatic renal cell carcinoma A Phase III, multicenter, randomised controlled study to compare safety and efficacy of a haploidentical HSCT and adjunctive treatment with ATIR101, a T- lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells, versus a haploidentical HSCT with post-transplant cyclophosphamide in patients with a hematologic malignancy (HATCY study) A Randomized, Global, Open-Label Study of Nivolumab in Combination with BMS vs Standard of Care Extreme chemotherapy in first-line recurrent/metastatic squamous cell carcinoma of the head and neck A multi-centre randomised study of induction chemotherapy followed by capecitabine (+/-nelfinavir) with high or standard dose radiotherapy for locally advanced non-metastatic pancreatic cancer 12/02/ /02/ /02/ /02/ /10/ /09/ /03/ /02/ /03/ /02/ /03/ /07/2016
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