2017-18 THS Annual Report - Clinical Trials and Research

Tasmanian Health Service

Research 2017 - 2018

Received DateResearch NameSummary
13/06/2017EPICCS 
01/08/2017Australian Genomics Health Alliance 
04/09/2017JumpBAT 
24/09/2017The RemiPCA SAFE Network - Data Sharing 
06/10/2017ACFDR - Cystic FibrosisOngoing data collection and submission to CFA data registry.
11/10/2017Continuous Glucose Monitoring Project (CGM) 
03/01/2018The Role of the Intensivist Care Nurse in the Rapid Response Team 
16/01/2018Nutrition in CF Study 
30/01/2018The RemiPCA SAFE Network - Data Sharing 
31/01/2018APCR 
22/02/2018Australian Genomics Health Aliance 
28/02/2018HIV Immunity and cancer cohort biobanking study 
15/03/2018Peri-Perii Project 
27/03/2018Evidenced Based Decision Making by Allied Health Managers 
29/03/2018The Kids Canccer Project 
24/04/2018Factors influencing physical activity in rehabilitation environments after stroke: a qualitative study 
16/05/2018The Impact of Participatory Creative Arts for Renal Patients 
23/05/2018Improved Monitoring of Multiple Sclerosis using Patient-derived and MRI Scan Information 
24/05/2018AOANJRR PROMs Pilot ProjectThe Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) has implemented a large national pilot project the test the feasibility of collecting PROMs pre and post-operative from patients undergoing joint replacement surgery in Australia.
The system has been integrated with current AOANJRR data collection and databases and has integrated flexibility to allow for the diverse health sector landscape in Australia. The trial has been implemented at 45 hospitals nationally.
Data collection commenced on the 30th July 2018, there are currently 3,257 patients registered in the system and 3,027 completed pre-operative PROMs. The 6-month post-operative follow-up will commence in January 2019.
Feedback is being received by hospital personnel assisting with the project and a review is already underway to determine what features of the project may need to be altered for a national rollout.
28/05/2018Patient Outcomes for Bariatric Surgery 
28/05/2018Evaluation of the Tasmanian Allied Health Practitioner Research Capacity Building Intervention 
01/06/2018A Blinded controlled Study of the Value of Objective Measurement in Treating Parkinson's Disease 
03/07/2018Neonateal Sepsis Study - N Spotswood 
20/07/2018The Kathleen Cuningham Foundation Consortium for Research into Familial Breast Cancer (kConFab) - IF-17-002 

Clinical Trials 2017 - 2018

Date ReceivedClinical Trial NameDepartmentSummary
02/06/2017Javelin Gastric 300OncologyA Phase III open-label, multicentre trial of avelumab (MSB0010718C) as a third-line treatment of unresectable, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma.
16/06/2017ITAC TrialAnaestheticsThis randomised, double-blind, controlled, phase 4 trial will compare the efficacy, safety and cost-effectiveness of preoperative IV iron with placebo in patients with anaemia before elective cardiac surgery.
Recruitment ongoing.
04/07/2017PLUS StudyCritical Care Medicine

Plasma-Lyte 148® versUs Saline study. A multi-centre, blinded, randomised, controlled trial to determine whether fluid resuscitation and therapy with a “balanced” crystalloid solution (Plasma-Lyte 148®) compared with 0.9% sodium chloride (saline) decreases 90-day mortality in critically ill patients requiring fluid resuscitation.
The PLUS study will test the hypothesis that in a heterogeneous population of critically ill adults random assignment to Plasma-Lyte 148® for intravascular volume resuscitation and crystalloid fluid therapy in the Intensive Care Unit (ICU) results in different 90-day all-cause mortality when compared with random assignment to 0.9% sodium chloride (saline) for the same treatment.

07/07/2017RANGER  
24/07/2017Wound ELECT  
26/07/2017EMR-100070-005  
07/08/2017AGILE  
30/08/2017ACOR  
06/09/2017TRITON 3OncologyA Multicentre, Randomized, Open-label Phase 3 Study of Rucaparib versus Physician's Choice of Therapy for Patients with Metastatic Castration-resistant Prostate Cancer Associated with Homologous Recombination Deficiency.
06/09/2017AMETHYSTOncologyPhase 2, Parallel-Arm Study of MGCD265 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Activating Genetic Alterations in Mesenchymal-Epithelial Transition Factor.
07/09/2017MM19OncologyA Phase 3 trial of thalidomide dexamethasone consolidation versus thalidomide-dexamethasone-Ixazomib consolidation for transplant eligible multiple myeloma patients undergoing a single ASCT as part of front-line therapy.
07/09/2017FGCL-4592-082OncologyA Phase 3 Randomized Double-Blind Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients with Lower Risk Myelodysplastic Syndrome (MDS) with Low Red Blood Cell (RBC) Transfusion Burden.
08/09/2017Checkpoint 401OncologyClinical Trial of Nivolumab (BMS-936558) Combined with Ipilimumab Followed by Nivolumab Monotherapy as First-Line Therapy of Subjects with Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma. CA209401.
15/09/2017APML5OncologyPharmacokinetic evaluation of oral arsenic trioxide in previously untreated patients with acute promyelocytic leukaemia (ALLG APML5 study).
21/09/2017BGB-3111-304-CCLOncologyAn International, Phase 3, Open-label, Randomized Study of BGB-3111 Compared with Bendamustine plus Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
27/09/2017IMSPIREOncologyA Phase 3, open-label, multicenter, two-arm, randomized study to investigate the efficacy and safety of cobimetinib plus atezolizumab versus pembrolizumab in patients with previously untreated advanced brafv600 wild-type melanoma.
05/10/2017STATECOncologyA randomised trial of non-Selective versus selective adjuvant Therapy in high risk Apparent sTage 1 Endometrial Cancer.
06/10/2017DYNAMIC  
06/10/2017MURANO  
13/10/2017SCRIBE  
18/10/2017ONCONOVA  
18/10/2017HARMONY  
18/10/2017PATCHCritical Care MedicinePre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage. A multi-centre randomised, double-blind, placebo-controlled trial of pre-hospital treatment with tranexamic acid for severely injured patients at risk of acute traumatic coagulopathy.
Coagulation (the formation of blood clots) is an important process in the body that helps control blood loss. Up to a quarter of severely injured people develop ATC. This affects the body’s ability to form blood clots and results in the breakdown of clots (fibrinolysis), leading to potentially increased blood loss.
The purpose of this research is to determine whether giving an anti-fibrinolytic drug called Tranexamic Acid (TXA) as early as possible to severely injured adults results in increased survival and improved recovery from their injuries.
27/10/2017The COPS Study Amendment #2  
30/11/2017NUTMEGOncologyA Randomised Phase II Study of NivolUmab and TeMozolomide vs Temozolomide alone in newly diagnosed Elderly patients with Glioblastoma (NUTMEG).
30/11/2017BR34OncologyA randomized trial of durvalumab and tremelimumab platinum based chemotherapy in patients with high-risk, metastatic (stage IV) squamous or non-squamous non-small cell lung cancer (NSCLC).
30/11/2017PEVONEDISTAT-3001OncologyA Phase 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia.
03/01/2018CKD-519CardiologyA Multicenter, parallel-group, double-blind, randomized, active-controlled, dose-ranging study to assess the safety, efficacy, and tolerability of CKD-519, administered with HMG-CoA reductase inhibitors, in subjects with dyslipidemia.
The current treatments for reducing risk of cardiovascular diseases focus mainly on reducing LDL-C levels.
The correlation between HDL-C levels and cardiovascular disease risk is still being investigated, and extensive clinical data support this correlation.
HDL has anti-atherogenic, anti-inflammatory, and anti-oxidant effects.
CKD-519 is an agent that decreases LDL-C levels and increases HDL-C levels in combination with any LDL-lowering drug so that it can be potentially used to prevent cardiovascular diseases.
08/01/2018MONARCCOncologyA randomised phase 2 study of Panitumumab monotherapy and panitumumab plus 5 fluorouracil as first line therapy for RAS and BRAF wild type metastatic colorectal cancer.
10/01/2018LYMRITOncologyA Phase I/II Study of (177Lu)-Lilotomab (Betalutin®) Radioimmunotherapy for Treatment of Relapsed Non-Hodgkin Lymphoma.
10/01/2018LRDROncologyTHE LYMPHOMA AND RELATED DISEASES REGISTRY (LRDR)
02/02/2018BGB3111-BGB317OncologyA Phase 1b, Open Label, Multiple Dose, Dose Escalation, and Expansion Study to Assess Safety, Tolerability, and Antitumor Activities of the Combination of BGB-3111 with BGB-A317 in Subjects with B-Cell Lymphoid Malignancies.
02/02/2018JAVELIN GASTRIC 100OncologyA Phase III open-label, multicenter trial of maintenance therapy with avelumab* (MSB0010718C) versus continuation of first-line chemotherapy in subjects with unresectable, locally advanced or metastatic, adenocarcinoma of the stomach, or of the gastro-esophageal junction.
02/02/2018NIVORADOncology

A randomised phase 2 trial of nivolumab and stereotactic ablative body radiotherapy in advanced non-small cell lung cancer progressing after first or second line chemotherapy.

13/02/2018NGORWomen's & Children's Services

The National Gynae-Oncology Registry (NGOR) is a clinical quality registry designed to measure and monitor patterns of care following diagnosis of gynaecological cancers. The aim of this registry is to identify variation in the treatments and outcomes of patients with newly diagnosed gynaecological cancers, with a view to improving patient outcomes and quality of care. The registry is currently in a pilot phase, collecting information on women with ovarian, tubal and peritoneal cancers across Victoria, Tasmania and New South Wales.

13/02/2018Australian Mepolizumab Reg. -AMRRespiratory MedicineThe AMR is a web-based database specifically designed to monitor the use mepolizumab which is an add-on treatment for patients with severe refractory eosinophilic asthma. AMR is a non-interventional, observational study of real-world outcomes. Ethics approval was granted 18 December 2017. The RHH contract agreement was finalised 21 May 2018. The site was initiated by the sponsor 24 May 2018. The first recruited participant signed their Informed Consent on 7th June 2018 and their baseline visit was 3rd August 2018. Subsequent participants were enrolled after July 2018
22/02/2018LIBERATEOncologyA phase II study evaluating liquid biopsies to profile metastatic colorectal cancer.
27/02/2018BLINGCritical Care Medicine

A phase III randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients.
Defined as life-threatening organ dysfunction due to infection, sepsis is a major cause of mortality worldwide. Gram-positive and Gram-negative bacteria, either alone or in combination with other pathogens, are the leading cause of sepsis.
Early use of effective antibiotic therapy against the initiating infection is central in the treatment of patients with sepsis. One important class of antibiotics commonly used to treat infection in patients with sepsis are beta-lactam antibiotics. The BLING III Study aims to determine whether continuous infusion of a beta-lactam antibiotic (piperacillin-tazobactam or meropenem) results in decreased all-cause Day 90 mortality compared with intermittent beta-lactam antibiotic infusion in critically ill patients with sepsis.

01/03/2018TESTOV PneumoPaediatricsEvaluation of the effectiveness of the 13-valent pneumococcal vaccine against pneumococcal pneumonia in children.
09/03/2018Denosumab Multiple Myeloma

Oncology

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Disease in Subjects with Newly.
09/03/2018PRAN-16-52 AML

Oncology

A 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.
13/03/2018PERSIA Registry

Oncology

Pertuzumab Study in the Neoadjuvant Setting for HER2-positive Non-metastatic Breast Cancer in Australia (PERSIA).
16/03/2018PADDI Trail - SubstudyAnaestheticsThe PADDI Trial is a large (8,880 patients) international, multicentre, prospective, randomised, double blind, placebo‐controlled, parallel assessment, stratified, non‐inferiority safety and effectiveness study. Its purpose is to establish thesafety of the administration of 8 mg of dexamethasone to adult patients undergoing non urgent surgical procedures under general anaesthesia of at least two hours duration and requiring at least one night’s stay in hospital postoperatively. Recruitment ongoing.
06/04/2018EPO-TBI LTFU STUDY  
10/04/2018BGB-3111-304-CCL

Oncology

An International, Phase 3, Open-label, Randomized Study of BGB-3111 Compared with Bendamustine plus Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
11/04/2018INOvation-1  
12/04/2018DYNAMIC III

Oncology

Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study (DYNAMIC-III).
24/04/2018GRIPHON OL: AC 0651A303  
30/04/2018DYNAMIC II

Oncology

Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage II Colon Cancer.
01/05/2018HARMONY

Oncology

GO29833 A PHASE Ib/II STUDY evaluating the safety and Efficacy OF obinutuzumab in combination with polatuzumab vedotin and venetoclax in PARTICIPANTS with relapsed or refractory Follicular or Diffuse Large B-Cell Lymphoma (HARMONY).
01/05/2018The COPS TrialCardiologyA multicentre, double-blind, randomised, placebo-controlled trial to assess the impact of low-dose colchicine on long-term cardiovascular outcomes in patients presenting with acute coronary syndromes.
This prospective multicentre study aims to investigate the long-term effects of adding low-dose colchicine to current medical therapy.
02/05/2018ONCONOVAOncologyA Phase III, International, Randomized, Controlled Study of Rigosertib versus Physician’s Choice of Treatment in Patients with Myelodysplastic Syndrome after Failure of a Hypomethylating Agent.
04/05/2018ESPERIONCardiologyA randomized, double-blind, placebo-controlled, Phase 3 study to evaluate the effects of Bempedoic Acid (ETC-1002) on the occurrence of major cardiovascular events in patients with, or at high risk for, Cardiovascular Disease who are statin intolerant.
The purpose of the study is to evaluate whether long-term treatment with bempedoic acid 180 mg/day versus placebo reduces the risk of major adverse cardiovascular events (MACE) in patients with, or at high risk for, cardiovascular disease (CVD) who are statin intolerant
07/05/2018POISE  
16/05/2018The AEGIS-II Study  
16/05/2018DIAMONDOncologyAn investigator-initiated, non-randomised, phase II study of combination CTLA-4 and PD-L1 blockade in combination with HER2 blockade in advanced HER2-positive breast cancers that have progressed on prior trastuzumab-based therapy.
17/05/2018ACE-CL-309OncologyA Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator’s Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia.
18/05/2018BGB-3111-AU-003OncologyA Phase I, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety and Pharmacokinetics of the BTK Inhibitor BGB-3111 in Subjects with B-Cell Lymphoid Malignancies.
18/05/2018RATIONALOncologyA randomised controlled feasibility trial comparing the efficacy of prophylactic intravenous immunoglobulin with prophylactic antibiotics in patients with acquired hypogammaglobulinemia secondary to haematological malignancies.
22/05/2018Echelon (Amendment 3)OncologyA Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma.
24/05/2018PCYC-114-CAOncologyA Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Rituximab versus Placebo in Combination with Rituximab in Treatment Naïve Subjects with Follicular Lymphoma.
25/05/2018AGRISCardiologyA Cluster Randomisation Trial of Objective Risk Assessment versus standard care for Acute Coronary Syndromes.
Refining risk-based decision-making to reduce “misperceptions” of risk leading to under-treatment of high-risk patients is the core objective of this study.
28/05/2018DYNAMIC (Sub-Study)  
28/05/2018CMR Guide HFCardiology

Cardiac Magnetic Resonance GUIDEd Management of mild –moderate Heart Failure.
To determine if the insertion of an Implantable Cardioverter Defibrillator (ICD) based on the presence of ventricular scar/fibrosis identified by Late Gadolinium Enhancement Cardiac Magnetic Resonance (LGE CMR), will reduce sudden cardiac death and/or ventricular arrhythmia in patients with mild-moderate LV systolic dysfunction.
A health economic evaluation of costs will also be carried out.

28/05/2018GLANCE  
30/05/2018ICON 9OncologyAn international phase III randomised study to evaluate the efficacy of maintenance therapy with olaparib and cediranib or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy.
01/06/2018A Blinded controlled Study of the Value of Objective Measurement in Treating Parkinson's Disease  
16/07/2018Second International Inter-Group Study for Classical Hodgkin’s Lymphoma in Children and AdolescentsPaediatricsTo reduce the indication for radiotherapy (RT) in newly diagnosed patients with classical Hodgkin lymphoma without compromising cure rates. To investigate a chemotherapy intensification randomisation in intermediate and advanced classical Hodgkin lymphoma (HL) to compensate for reduction in RT.
16/07/2018HD10OncologyTreatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma; comparison of 4 cycles of escalated BEACOPP with 4 cycles of BrECADD.
16/07/2018STIMULIOncologyA randomised open-label phase 2 trial of consolidation with nivolumab and ipilimumab in limited-stage SCLC after concurrent chemo-radiotherapy.
16/07/2018APP1142980 - FL PrognosticOncologyPembrolizumab with Combination Chemotherapy and Radiotherapy in Participants with Stage III Non-Small Cell Lung Cancer (NSCLC).
16/07/2018MSD MK3475-799OncologyA Phase 3 Randomized, Placebo-controlled Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus.
30/07/2018Phase 3 64091742PCR3001 studyOncologyA Phase 3 Randomized, Placebo-controlled Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for First-Line Treatment of Subjects with Metastatic Castration-resistant Prostate Cancer (mCRPC) and DNA Repair Defects.