Phase 1 Trial of CXD101 in Patients With Advanced Cancer

Transcription

1 Trial Summary There are currently 28 trials Phase 1 Trial of CXD101 in Patients With Advanced Cancer Treatment: CXD101 Myeloma stage: Relapsed, Refractory, Newly Diagnosed, High risk myeloma Trial phase: I There are 1 running this trial. - Oxford University Hospital, Oxford The purpose of this study is to determine the highest dose of CXD101 (a novel histone deacetylase inhibitor) that can be safely administered to patients with advanced tumours. The study will also investigate the use of HR23B expression in tumour as a biomarker of response to treatment with CXD101. Page 1/28

2 MGUS research study Myeloma stage: MGUS There are 9 running this trial. - Royal Berkshire Hospital, Reading; - Addenbrooke's Hospital, Cambridge; - Torbay Hospital, Torquay; - Heartlands Hospital, Birmingham; - St James' Hospital, Leeds; - Guy's Hospital, London; - Freeman Hospital, Newcastle; - City Hospital, Nottingham; - Rotherham General Hospital, Rotherham The aim of this study is to gain an understanding of the functional consequences of paraprotein production in monoclonal gammopathy of undetermined significance (MGUS) patients. In most cases of MGUS patients do not experience symptoms. However, in a small number of patients there may be an interaction of the paraprotein with a molecule expressed by the body (self antigen) which can have effects on the normal function of this molecule and may cause disease. AZD4573 in relapsed or refractory myeloma Page 2/28

3 Treatment: AZD4753 Myeloma stage: Relapsed, Refractory Trial phase: I There are 4 running this trial. - University Hospital of Wales, Cardiff; - The Christie Hospital, Manchester; - Derriford Hospital, Plymouth; - The Royal Marsden Hospital, Sutton The aim of this study is to determine the safety and efficacy of AZD473 in relapsed and refractory myeloma patients. AZD4753 is a new drug and belongs to a class of drug known as cyclin-dependent kinase inhibitors. Daratumumab vs. monitoring in high risk smouldering myeloma Treatment: Darzalex Myeloma stage: Smouldering Trial phase: III Page 3/28

4 There are 3 running this trial. - Heartlands Hospital, Birmingham; - Kent and Canterbury Hospital, Canterbury; - St Bartholomew's Hospital, London The aim of this trial is to determine whether treatment with daratumumab can delay progression to active myeloma in patients with high risk smouldering myeloma, compared to active monitoring. Selinexor for relapsed and refractory myeloma (BOSTON) Treatment: Selinexor, Velcade, Dexamethasone Myeloma stage: Relapsed, Refractory Trial phase: III There are 9 running this trial. - Ninewells Hospital, Dundee; - Western General Hospital, Edinburgh; - Queen Elizabeth Hospital, Birmingham; - Leicester Royal Infirmary, Leicester; - Northwick Park Hospital, Harrow; - King's College Hospital, London; Page 4/28

5 - Hammersmith Hospital, London; - The Christie Hospital, Manchester; - Freeman Hospital, Newcastle The aim of this study is to determine whether the addition of selinexor to bortezomib and dexamethasone is more effective than bortezomib and dexamethasone alone in patients with relapsed or refractory myeloma. Selinexor is the first in a new family of drugs known as selective inhibitor of nuclear export (SINE) compounds. This study is also known as the BOSTON trial. RO monotherapy and combination for relapsed and refractory myeloma patients Treatment: RO Myeloma stage: Relapsed, Refractory Trial phase: I There are 3 running this trial. - University College Hospital, London; - Churchill Hospital, Oxford; - Oxford University Hospital, Oxford Page 5/28

6 The aim of this study is to determine whether RO alone and in combination with daratumumab is safe for use in relapsed and/or refractory myeloma patients. It is aiming to identify the best dose of RO to use. RO belongs to a new class of drug called BET inhibitors. Subcutaneous vs. intravenous daratumumab in relapsed and/or refractory myeloma Treatment: Darzalex Myeloma stage: Relapsed, Refractory Trial phase: III There are 7 running this trial. - Blackpool Victoria Hospital, Blackpool; - City Hospital, Nottingham; - Royal Bournemouth Hospital, Bournemouth; - Leicester Royal Infirmary, Leicester; - St Bartholomew's Hospital, London; - Guy's Hospital, London; - New Cross Hospital, Wolverhampton The aim of this trial is to determine whether subcutaneous daratumumab (injection under the skin) is Page 6/28

7 as effective as intravenous daratumumab (into the vein) in patients with relapsed and/or refractory myeloma. Ixazomib, pomalidomide and dexamethasone for relapsed and/or refractory myeloma patients Treatment: Ninlaro, Imnovid, Dexamethasone Myeloma stage: Relapsed, Refractory Trial phase: II, III There are 2 running this trial. - Glan Clwyd Hospital, Bodelwyddan; - Royal Bournemouth Hospital, Bournemouth The purpose of this study is to determine whether ixazomib in combination with dexamethasone is more effective than pomalidomide in combination with dexamethasone for prolonging progression-free survival in relapsed and/or refractory myeloma patients. Ixazomib, also known as Ninlaro, is a proteasome inhibitor. Page 7/28

8 Targeted radiotherapy for myeloma Treatment: Radiotherapy Myeloma stage: Relapsed, Newly Diagnosed Trial phase: I, II There are 2 running this trial. - Royal Free Hospital, London; - Southampton General Hospital, Southampton The purpose of this study is to determine whether a radiolabelled antibody can be used to safely deliver radiotherapy to the bone marrow ahead of a stem cell transplant in patients who have high risk myeloma. While stem cell transplants have been demonstrated to be effective treatments for myeloma, the results seen in patients with high risk disease is poor. Intensifying treatment prior to transplant has been shown to improve patient outcomes, and reduce the risk of relapse. Targeted radiotherapy may be an option for intensifying treatment and killing more myeloma cells prior to transplant without the side-effects associated with standard treatments, for example high-dose chemotherapy. Page 8/28

9 Pre-transplant exercise for myeloma patients (PREeMPT) Treatment: Exercise programme Myeloma stage: Relapsed, Newly Diagnosed There are 1 running this trial. - Royal Hallamshire Hospital, Sheffield The aim of this study is to determine whether it is acceptable to offer an exercise programme to myeloma patients awaiting an autologous stem cell transplant. Prehabilitation (exercise after diagnosis but before treatment or surgery) has been shown to be effective in reducing the severity of side-effects of treatments in cancer patients, however there is currently no evidence for myeloma patients. This trial is also known as the PREeMPT trial. Observational study of presentation, treatment and outcomes in myeloma patients (INSIGHT-MM) Page 9/28

10 Treatment: Observation Myeloma stage: Relapsed, Refractory, Newly Diagnosed There are 10 running this trial. - Royal United Hospital, Bath; - Queen Elizabeth Hospital, Birmingham; - Heartlands Hospital, Birmingham; - Royal Bournemouth Hospital, Bournemouth; - Ninewells Hospital, Dundee; - Leeds Teaching Hospitals NHS Trust, Leeds; - Leicester Royal Infirmary, Leicester; - Nottingham University Hospitals NHS Trust; - The Royal Marsden Hospital, Sutton; - Pinderfields General Hospital, Wakefield The aim of this study is to gather real-world data on the presentation, treatment patterns and clinical outcomes of newly diagnosed, relapsed and refractory myeloma patients to improve understanding and knowledge of the disease. Observational evaluation of myeloma patients (PREAMBLE) Treatment: Observation Page 10/28

11 Myeloma stage: Relapsed, Refractory There are 6 running this trial. - Royal Cornwall Hospital, Truro; - St James' Hospital, Leeds; - Royal Liverpool Hospital, Liverpool; - Nottingham University Hospitals NHS Trust; - Stafford County Hospital, Stafford; - Singleton Hospital, Swansea The aim of this observational study is to gather real-world data on the effectiveness of novel agents, such as bortezomib (Velcade ) and lenalidomide (Revlimid ), and the impact on patients to improve understanding and knowledge of myeloma. This study is also known as PREAMBLE. Image guided theranostics in myeloma (itimm) Myeloma stage: Relapsed, Newly Diagnosed There are 1 running this trial. - The Royal Marsden Hospital, Sutton Page 11/28

12 The purpose of this study is to determine the best time to perform imaging to detect any remaining myeloma cells in patients after undergoing high-dose therapy and autologous stem cell transplant (HDT-ASCT). There is evidence to suggest that detection of residual disease following HDT-ASCT indicates a worse prognosis, and patients may need to undergo further treatment. In this study, whole body diffusion weighted MRI (WB-DWI) will be used to detect myeloma in patients following HDT-ASCT. Acupuncture for chemotherapy induced peripheral neuropathy in myeloma (ACUFOCIN) Treatment: Acupuncture Myeloma stage: Relapsed, Refractory, Newly Diagnosed Trial phase: II There are 1 running this trial. - The Christie Hospital, Manchester The aim of this study is to determine whether acupuncture can reduce the level of peripheral neuropathy experienced by myeloma patients receiving chemotherapy, when given in conjunction with standard treatments for managing symptoms of peripheral neuropathy. Page 12/28

13 Ixazomib maintenance treatment for newly diagnosed myeloma patients Treatment: Ninlaro Myeloma stage: Newly Diagnosed Trial phase: III There are 17 running this trial. - Belfast City Hospital, Northern Ireland; - Heartlands Hospital, Birmingham; - Bristol Haematology and Oncology Centre; - Kent and Canterbury Hospital, Canterbury; - Barts Health NHS Trust, London; - King's College Hospital, London; - Hammersmith Hospital, London; - Hillingdon Hospital, Uxbridge; - James Paget Hospital, Great Yarmouth; - Churchill Hospital, Oxford; - The Royal Marsden Hospital, Sutton; - Royal United Hospital, Bath; - Southmead Hospital, Bristol; - University Hospital of Wales, Cardiff; - Leicester Royal Infirmary, Leicester; - Northwick Park Hospital, Harrow; - Singleton Hospital, Swansea Page 13/28

14 The aim of this study is to determine whether ixazomib (Ninlaro ) maintenance treatment can improve progression-free survival in newly diagnosed myeloma patients who have responded well to initial treatment, but who have not had a stem cell transplant. MUK nine b: OPTIMUM Treatment: Velcade, Revlimid, Darzalex, Dexamethasone, Cyclophosphamide Myeloma stage: Newly Diagnosed, High risk myeloma Trial phase: II There are 17 running this trial. - The Royal Marsden Hospital, Sutton; - Barts Health NHS Trust, London; - Leeds Teaching Hospitals NHS Trust, Leeds; - King's College Hospital, London; - Southampton General Hospital, Southampton; - Guy's Hospital, London; - University Hospitals of Leicester NHS Trust; - University Hospitals Bristol NHS Foundation Trust; - Queen Elizabeth Hospital, Birmingham; - Heartlands Hospital, Birmingham; - Manchester Royal Infirmary, Manchester; - Belfast City Hospital, Northern Ireland; - Ninewells Hospital, Dundee; - The Beatson Institute, Glasgow; Page 14/28

15 - Addenbrooke's Hospital, Cambridge; - Oxford Radcliffe Hospital, Oxford; - Nottingham University Hospitals NHS Trust The aim of this study is to determine whether a combination of bortezomib, lenalidomide, daratumumab and dexamethasone, together with low-dose cyclophosphamide, is effective as a treatment for patients with high risk myeloma. CAR-T cell therapy for relapsed and/or refractory myeloma (APRIL) Treatment: CAR T cell therapy, Cyclophosphamide, Fludarabine Myeloma stage: Relapsed, Refractory Trial phase: I, II There are 3 running this trial. - University College Hospital, London; - The Christie Hospital, Manchester; - Freeman Hospital, Newcastle This trial is investigating whether AUTO2, a type of treatment known as chimeric antigen receptor T cell (CAR T cell) therapy, is effective for myeloma patients. The first part of the trial (Phase I) is Page 15/28

16 aiming to determine the safety and best dose of AUTO2 to take forward to evaluate its effectiveness in treating the myeloma in the second part of the trial (Phase II). CAR T cell therapy itself is a new type of immunotherapy in which a patient s T cells (a type of white blood cell) are harvested and genetically modified in the laboratory. They are then given back to the patient. The aim is to enable the modified T cells to better recognise and destroy the myeloma cells. With AUTO2, the patient s T cells are designed to recognise two molecules, BCMA and TACI, both present on the surface of myeloma cells. Melflufen and dexamethasone in myleoma patients refractory to lenalidomide (OCEAN trial) Treatment: Melflufen, Imnovid, Dexamethasone Myeloma stage: Relapsed, Refractory Trial phase: III There are 4 running this trial. - The Christie Hospital, Manchester; - Milton Keynes University Hospital; - Royal Liverpool Hospital, Liverpool; - The purpose of this trial is to compare the effectiveness of melflufen plus dexamethasone to pomalidomide plus dexamethasone in terms of prolonging progression-free survival (PFS) in Page 16/28

17 relapsed and refractory myeloma patients. Melflufen is a modified version of the chemotherapy drug melphalan. This trial is also known as the OCEAN trial. TAS-120 for refractory myeloma patients with FGF/FGFR abnormalities Treatment: TAS-120 Myeloma stage: Refractory Trial phase: II There are 3 running this trial. - Sarah Cannon Research Institute, London; - University College Hospital, London; - The purpose of this trial is to determine the safety and efficacy of TAS-120 in refractory myeloma patients who have fibroblast growth factor/fibroblast growth factor receptor (FGF/FGFR) abnormalities. Genetic abnormalities that affect the FGF/FGFR signalling pathway are linked to many cancers including myeloma. TAS-120 is an inhibitor of FGFR and so is being researched as a myeloma treatment. Page 17/28

18 CC-220 monotherapy and combination for relapsed and refractory myeloma patients Treatment: CC-220, Dexamethasone Myeloma stage: Relapsed, Refractory Trial phase: I, II There are 3 running this trial. - St James' Hospital, Leeds; - University College London; - The Institute of Cancer Research, London This trial is looking to find the best dose of a new drug called CC-220 for relapsed and/or refractory myeloma patients. This drug will be tested on its own and in combination with dexamethasone. CC-220 is a new immunomodulatory drug. Relapsed and/or refractory myeloma patients who have had at least two previous lines of treatment with lenalidomide (Revlimid ) or pomalidomide (Imnovid ), and a proteasome inhibitor, for example, bortezomib (Velcade ). Page 18/28

19 MUK eleven (Reolysin trial) Treatment: Pelareorep, Revlimid, Imnovid Myeloma stage: Relapsed, Refractory Trial phase: I There are 1 running this trial. - St James' Hospital, Leeds This trial is investigating whether Reolysin, a type of viral therapy, can halt relapse in patients who are being treated with lenalidomide (Revlimid ) or pomalidomide (Imnovid ). It is specifically looking to identify the best dose of Reolysin to use. Myeloma XII (ACCoRd) Treatment: Ninlaro, Thalidomide, Dexamethasone, Autologous stem cell transplant Myeloma stage: Relapsed Trial phase: III Page 19/28

20 There are 89 running this trial. - City Hospital, Nottingham; - Ninewells Hospital, Dundee; - Queen Elizabeth Hospital, Birmingham; - Southampton General Hospital, Southampton; - St Bartholomew's Hospital, London; - St James' Hospital, Leeds; - University College Hospital, London; - Norwich and Norfolk University Hospital, Norwich; - Lincoln County Hospital, Lincoln; - Pilgrim Hospital, Boston; - Grantham and District Hospital, Grantham; - Salisbury District Hospital, Salisbury; - Countess of Chester Hospital, Chester; - Queens Hospital, Burton upon Trent; - Blackpool Victoria Hospital, Blackpool; - St Helens Hospital, Merseyside; - Barnsley Hospital, Barnsley; - Russells Hall Hospital, Dudley; - Pinderfields General Hospital, Wakefield; - Royal Stoke University Hospital, Stoke; - King's Mill Hospital, Sutton-in-Ashfield; - Freeman Hospital, Newcastle; - Calderdale Royal Hospital, Halifax; - Huddersfield Royal Infirmary, Huddersfield; - The Beatson Institute, Glasgow; - Leicester Royal Infirmary, Leicester; - Bradford Royal Infirmary, Bradford; - Torbay Hospital, Torquay; - The Royal Marsden Hospital, Sutton; - Worcester Royal Hospital, Worcester; - University Hospital Crosshouse, Kilmarnock; - University Hospital, Ayr; - The Christie Hospital, Manchester; - Monklands Hospital, Airdrie; - Bristol Haematology and Oncology Centre; - Addenbrooke's Hospital, Cambridge; - Derriford Hospital, Plymouth; - Royal Alexandra Hospital, Paisley; - North Hampshire Hospital, Basingstoke; - Royal Hampshire County Hospital, Winchester; Page 20/28

21 - Royal Derby Hospital, Derby; - Royal United Hospital, Bath; - St Helier Hospital, Carshalton; - Chesterfield Royal Hospital, Chesterfield; - James Cook University Hospital, Middlesbrough; - Royal Hallamshire Hospital, Sheffield; - Ipswich Hospital, Ipswich; - North Tyneside General Hospital, North Shields; - Maidstone Hospital, Maidstone; - Tunbridge Wells Hospital, Tunbridge Wells; - Aintree University Hospital, Liverpool; - Milton Keynes University Hospital; - Royal Liverpool Hospital, Liverpool; - Heartlands Hospital, Birmingham; - Good Hope Hospital, West Midlands; - Aberdeen Royal Infirmary, Aberdeen; - Alexandra Hospital, Redditch; - Borders General Hospital. Melrose; - Cheltenham General Hospital, Cheltenham; - Churchill Hospital, Oxford; - Dewsbury and District Hospital, Dewsbury; - Diana, Princess of Wales Hospital, Grimsby; - Gloucester Royal Hospital, Gloucester; - Hairmyres Hospital, East Kilbride; - Harrogate District Hospital, Harrogate; - Kidderminster Hospital, Kidderminster; - Manchester Royal Infirmary, Manchester; - Musgrove Park Hospital, Taunton; - New Cross Hospital, Wolverhampton; - New Victoria Hospital, Glasgow; - Pontefract Hopsital, Pontefract; - Raigmore Hospital, Inverness; - Royal Bournemouth Hospital, Bournemouth; - Royal Oldham Hospital, Oldham; - Salford Royal Hospital, Salford; - Scunthorpe General Hospital, Scunthorpe; - Singleton Hospital, Swansea; - Southmead Hospital, Bristol; - Stafford County Hospital, Stafford; - Stepping Hill Hospital, Stockport; - University Hospital Coventry, Coventry; - Wansbeck General Hospital, Ashington; Page 21/28

22 - Western General Hospital, Edinburgh; - Whiston Hospital, Prescot; - Wishaw General Hospital, Wishaw; - Castle Hill Hospital, Cottingham; - King's College Hospital, London; - St Richard's Hospital, Chichester; - St George s Hospital, London The Myeloma XII trial is designed for myeloma patients at first relapse who have previously had a stem cell transplant and are now considering a second transplant. The aim is to determine whether adding ixazomib (Ninlaro ) to conventional high-dose melphalan treatment can improve the depth of response of the second stem cell transplant, and whether ixazomib consolidation and maintenance treatment post-transplant can prolong the period of remission. Ixazomib and dexamethasone for relapsed or refractory AL amyloidosis patients Treatment: Ninlaro, Dexamethasone Myeloma stage: AL amyloidosis Trial phase: III There are 3 running this trial. Page 22/28

23 - Queen Elizabeth Hospital, Birmingham; - The Royal Free Hospital, London; - Manchester Royal Infirmary, Manchester This trial is determining whether ixazomib in combination with dexamethasone is more effective than current standard treatment in relapsed or refractory AL amyloidosis in terms of improving blood results and organ function. MUK eight Treatment: Ninlaro, Cyclophosphamide, Dexamethasone Myeloma stage: Relapsed, Refractory Trial phase: II There are 18 running this trial. - Queen Elizabeth Hospital, Birmingham; - Heartlands Hospital, Birmingham; - Royal Bournemouth Hospital, Bournemouth; - University Hospitals Bristol NHS Foundation Trust; - University Hospital of Hartlepool, Hartlepool; - St James' Hospital, Leeds; - Royal Liverpool Hospital, Liverpool; - Barts Health NHS Trust, London; - University College Hospital, London; Page 23/28

24 - Guy's Hospital, London; - The Royal Marsden Hospital, Sutton; - Imperial College Hospital, London; - The Christie Hospital, Manchester; - Nottingham University Hospitals NHS Trust; - Churchill Hospital, Oxford; - Southampton General Hospital, Southampton; - New Cross Hospital, Wolverhampton; - Northern General Hospital, Sheffield This trial, known as the MUK eight trial, is investigating whether a new treatment combination of ixazomib, cyclophosphamide and dexamethasone is more effective than cyclophosphamide and dexamethasone in relapsed and/or refractory myeloma patients. Ixazomib (also known as Ninlaro) is a new oral proteasome inhibitor which works in a similar way to Velcade. Carfilzomib for newly diagnosed patients prior to stem cell transplant (CARDAMON trial) Treatment: Kyprolis, Cyclophosphamide, Dexamethasone, Autologous stem cell transplant Myeloma stage: Newly Diagnosed Trial phase: II Page 24/28

25 There are 15 running this trial. - Churchill Hospital, Oxford; - Heartlands Hospital, Birmingham; - St George s Hospital, London; - St Bartholomew's Hospital, London; - University College Hospital, London; - Barnet Hospital, Barnet; - Royal United Hospital, Bath; - Guy's Hospital, London; - Medway Maritime Hospital, Gillingham; - King's College Hospital, London; - Queen s Hospital, Romford; - Kent and Canterbury Hospital, Canterbury; - University Hospital of Wales, Cardiff; - St James' Hospital, Leeds; - Maidstone Hospital, Maidstone This trial is for younger and/or fitter newly diagnosed myeloma patients. It is determining whether patients should be given high-dose therapy and a stem cell transplant straight after their induction treatment, or if they have responded well, whether it is better to delay the high-dose therapy and stem cell transplantation until relapse. All patients in this trial receive carfilzomib maintenance treatment. This is also known as the CARDAMON trial. Bendamustine combination for newly diagnosed myeloma patients with kidney impairment (OPTIMAL trial) Page 25/28

26 Treatment: Bendamustine, Velcade, Thalidomide, Dexamethasone Myeloma stage: Newly Diagnosed Trial phase: II There are 5 running this trial. - Churchill Hospital, Oxford; - Queen Alexandra Hospital, Portsmouth; - St Helier Hospital, Carshalton; - Kent and Canterbury Hospital, Canterbury; - Royal Liverpool Hospital, Liverpool This trial is for newly diagnosed patients who have kidney problems related to their myeloma. It is comparing the effectiveness of bendamustine (chemotherapy), bortezomib and dexamethasone (BBD) against bendamustine, thalidomide and dexamethasone (BTD) in reducing free light chains and helping the kidneys to recover. OPTIMAL stands for Optimising renal outcomes in Myeloma renal failure. GSK trial Treatment: GSK Myeloma stage: Relapsed, Refractory Trial phase: I Page 26/28

27 There are 1 running this trial. - University College Hospital, London This trial is looking to find the best dose of a new drug called GSK for relapsed and/or refractory myeloma patients. GSK belongs to a class of drug called monoclonal antibodies. It specifically targets a protein called B-cell maturation antigen. GSK trial Treatment: GSK Myeloma stage: Relapsed, Refractory Trial phase: I There are 1 running this trial. - Addenbrooke's Hospital, Cambridge This trial is looking to find the best dose of a new drug called GSK for relapsed and/or refractory myeloma patients. GSK belongs to a new class of drug called BET inhibitors. It specifically targets a protein called BRD4. Page 27/28

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