2017-18 THS Annual Report - Clinical Trials and Research
|Received Date||Research Name||Summary|
|01/08/2017||Australian Genomics Health Alliance|
|24/09/2017||The RemiPCA SAFE Network - Data Sharing|
|06/10/2017||ACFDR - Cystic Fibrosis||Ongoing data collection and submission to CFA data registry.|
|11/10/2017||Continuous Glucose Monitoring Project (CGM)|
|03/01/2018||The Role of the Intensivist Care Nurse in the Rapid Response Team|
|16/01/2018||Nutrition in CF Study|
|30/01/2018||The RemiPCA SAFE Network - Data Sharing|
|22/02/2018||Australian Genomics Health Aliance|
|28/02/2018||HIV Immunity and cancer cohort biobanking study|
|27/03/2018||Evidenced Based Decision Making by Allied Health Managers|
|29/03/2018||The Kids Canccer Project|
|24/04/2018||Factors influencing physical activity in rehabilitation environments after stroke: a qualitative study|
|16/05/2018||The Impact of Participatory Creative Arts for Renal Patients|
|23/05/2018||Improved Monitoring of Multiple Sclerosis using Patient-derived and MRI Scan Information|
|24/05/2018||AOANJRR PROMs Pilot Project||The 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.
|28/05/2018||Patient Outcomes for Bariatric Surgery|
|28/05/2018||Evaluation of the Tasmanian Allied Health Practitioner Research Capacity Building Intervention|
|01/06/2018||A Blinded controlled Study of the Value of Objective Measurement in Treating Parkinson's Disease|
|03/07/2018||Neonateal Sepsis Study - N Spotswood|
|20/07/2018||The Kathleen Cuningham Foundation Consortium for Research into Familial Breast Cancer (kConFab) - IF-17-002|
|Date Received||Clinical Trial Name||Department||Summary|
|02/06/2017||Javelin Gastric 300||Oncology||A Phase III open-label, multicentre trial of avelumab (MSB0010718C) as a third-line treatment of unresectable, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma.|
|16/06/2017||ITAC Trial||Anaesthetics||This 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.
|04/07/2017||PLUS Study||Critical 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.
|06/09/2017||TRITON 3||Oncology||A 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.|
|06/09/2017||AMETHYST||Oncology||Phase 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.|
|07/09/2017||MM19||Oncology||A 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.|
|07/09/2017||FGCL-4592-082||Oncology||A 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.|
|08/09/2017||Checkpoint 401||Oncology||Clinical 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.|
|15/09/2017||APML5||Oncology||Pharmacokinetic evaluation of oral arsenic trioxide in previously untreated patients with acute promyelocytic leukaemia (ALLG APML5 study).|
|21/09/2017||BGB-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.|
|27/09/2017||IMSPIRE||Oncology||A 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.|
|05/10/2017||STATEC||Oncology||A randomised trial of non-Selective versus selective adjuvant Therapy in high risk Apparent sTage 1 Endometrial Cancer.|
|18/10/2017||PATCH||Critical Care Medicine||Pre-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.
|27/10/2017||The COPS Study Amendment #2|
|30/11/2017||NUTMEG||Oncology||A Randomised Phase II Study of NivolUmab and TeMozolomide vs Temozolomide alone in newly diagnosed Elderly patients with Glioblastoma (NUTMEG).|
|30/11/2017||BR34||Oncology||A 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).|
|30/11/2017||PEVONEDISTAT-3001||Oncology||A 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.|
|03/01/2018||CKD-519||Cardiology||A 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.
|08/01/2018||MONARCC||Oncology||A 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.|
|10/01/2018||LYMRIT||Oncology||A Phase I/II Study of (177Lu)-Lilotomab (Betalutin®) Radioimmunotherapy for Treatment of Relapsed Non-Hodgkin Lymphoma.|
|10/01/2018||LRDR||Oncology||THE LYMPHOMA AND RELATED DISEASES REGISTRY (LRDR)|
|02/02/2018||BGB3111-BGB317||Oncology||A 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.|
|02/02/2018||JAVELIN GASTRIC 100||Oncology||A 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.|
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.
|13/02/2018||NGOR||Women'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.
|13/02/2018||Australian Mepolizumab Reg. -AMR||Respiratory Medicine||The 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|
|22/02/2018||LIBERATE||Oncology||A phase II study evaluating liquid biopsies to profile metastatic colorectal cancer.|
|27/02/2018||BLING||Critical Care Medicine||
A phase III randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients.
|01/03/2018||TESTOV Pneumo||Paediatrics||Evaluation of the effectiveness of the 13-valent pneumococcal vaccine against pneumococcal pneumonia in children.|
|09/03/2018||Denosumab Multiple Myeloma||
|A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Disease in Subjects with Newly.|
|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.|
|Pertuzumab Study in the Neoadjuvant Setting for HER2-positive Non-metastatic Breast Cancer in Australia (PERSIA).|
|16/03/2018||PADDI Trail - Substudy||Anaesthetics||The 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.|
|06/04/2018||EPO-TBI LTFU STUDY|
|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.|
|Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study (DYNAMIC-III).|
|24/04/2018||GRIPHON OL: AC 0651A303|
|Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage II Colon Cancer.|
|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).|
|01/05/2018||The COPS Trial||Cardiology||A 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.
|02/05/2018||ONCONOVA||Oncology||A 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.|
|04/05/2018||ESPERION||Cardiology||A 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
|16/05/2018||The AEGIS-II Study|
|16/05/2018||DIAMOND||Oncology||An 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.|
|17/05/2018||ACE-CL-309||Oncology||A 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.|
|18/05/2018||BGB-3111-AU-003||Oncology||A 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.|
|18/05/2018||RATIONAL||Oncology||A randomised controlled feasibility trial comparing the efficacy of prophylactic intravenous immunoglobulin with prophylactic antibiotics in patients with acquired hypogammaglobulinemia secondary to haematological malignancies.|
|22/05/2018||Echelon (Amendment 3)||Oncology||A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma.|
|24/05/2018||PCYC-114-CA||Oncology||A 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.|
|25/05/2018||AGRIS||Cardiology||A 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.
|28/05/2018||CMR Guide HF||Cardiology||
Cardiac Magnetic Resonance GUIDEd Management of mild –moderate Heart Failure.
|30/05/2018||ICON 9||Oncology||An 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.|
|01/06/2018||A Blinded controlled Study of the Value of Objective Measurement in Treating Parkinson's Disease|
|16/07/2018||Second International Inter-Group Study for Classical Hodgkin’s Lymphoma in Children and Adolescents||Paediatrics||To 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.|
|16/07/2018||HD10||Oncology||Treatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma; comparison of 4 cycles of escalated BEACOPP with 4 cycles of BrECADD.|
|16/07/2018||STIMULI||Oncology||A randomised open-label phase 2 trial of consolidation with nivolumab and ipilimumab in limited-stage SCLC after concurrent chemo-radiotherapy.|
|16/07/2018||APP1142980 - FL Prognostic||Oncology||Pembrolizumab with Combination Chemotherapy and Radiotherapy in Participants with Stage III Non-Small Cell Lung Cancer (NSCLC).|
|16/07/2018||MSD MK3475-799||Oncology||A Phase 3 Randomized, Placebo-controlled Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus.|
|30/07/2018||Phase 3 64091742PCR3001 study||Oncology||A 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.|