early phase clinical trial network
DESCRIPTION
Early Phase Clinical Trial Network. UKMF Spring Day - 13 March 2013. Strategic The most pertinent clinical studies are identified based on Key Objectives and developed and prioritised by a Steering Group of myeloma specialists. Collaborative - PowerPoint PPT PresentationTRANSCRIPT
HJM UKMF Spring Day – 13 March 2013
Early PhaseClinical Trial Network
UKMF Spring Day - 13 March 2013
HJM UKMF Spring Day – 13 March 2013
CTN Objectives
StrategicThe most pertinent clinical studies are identified based on Key Objectives and developed and prioritised by a Steering Group of myeloma specialists.
CollaborativeStakeholders throughout the NHS, HTA, Patients and the Pharmaceutical Industry work together to implement the most effective clinical trial design and ensure effective adoption of data.
EfficientWorking as a network, coordinated via a central office with standard processes and procedures and working with NHS and industry stakeholders, the CTN aims to break down the barriers that delay research enabling studies to be delivered quickly and effectively.
HJM UKMF Spring Day – 13 March 2013
Bringing Stakeholders Together
Clinical Experts Leeds Clinical TrialsCoordinating Office
HJM UKMF Spring Day – 13 March 2013
CTN Network
Leeds Clinical TrialsCoordinating Office
St James’s,Leeds
City,Nottingham
QE,Birmingham
The Christie,Manchester
RMH,London
UCLH,London
King’s,London
Bart’s,London
R HallamshireSheffield
General H,Southampton
Uni H Wales,Cardiff
Uni Hospital,Oxford
Central Trial Office
8 Core Active Trial Centres
4 AdditionalCentres
Expansioninc. Scotland& N Ireland
HJM UKMF Spring Day – 13 March 2013
CTN is part of a wider objective
Other areas include:
• Improving the setting for adoption of non-commercial data
• Making best use of available resources, especially patients
• Promote novel clinical trial designs
• Supporting novel approaches to licensing e.g. adaptive licensing
• Developing novel drug life-cycle strategies
• Addressing health economic barriers
• Collaboration with pharmaceutical companies
• Development of “Pathways Model” to identify future optimum therapy
CTN trials are one part of a wider Myeloma UK objective to impact how clinical trial data is generated and adopted, to more effectively bring optimum treatments to patients.
HJM UKMF Spring Day – 13 March 2013
Strategic Approach to Selecting Trials
Personalised Medicine
• Individualised treatment based on diagnostic biomarkers (i.e. genetic subgroups)
• Individualised treatment based on clinical presentation (clinical subgroups e.g. elderly/frail, high risk)
Access to Treatments
• Promoting novel treatments
• Identifying evidence gaps for drugs currently in development that may prevent or delay them being approved by NICE and/or taken into UK practice.
• Planning studies around expected life-cycle of a drug in real world setting
CTN trials are identified and prioritised based on two objectives:
HJM UKMF Spring Day – 13 March 2013
Current Portfolio of MUK Trials
MUK No.
Test Drug Title Status
MUK one
Bendamustine(Napp)
An open label, multi-centre, randomised, parallel group phase II selection trial to identify the optimal starting dose of bendamustine (60 vs 100 mg/m2) when given in combination with thalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.
COMPLETED patient recruitment,
in analysis
MUK three
CHR3996 & Tosedostat(Chroma)
A Phase I/IIa, Dose-Escalation, Study of CHR-3996 in Combination with Tosedostat in Subjects with Relapsed, Refractory Multiple Myeloma.
OPENRecruiting patients
to Phase I
MUK four
Vorinostat(MSD)
An open label, single arm, phase II trial to assess the efficacy, safety and tolerability of vorinostat in combination with bortezomib and dexamethasone (VVD) in patients with relapsed or relapsed refractory multiple myeloma.
Expected to open 2Q 2013
MUK five
Carfilzomib(Onyx)
A phase II randomised trial of carfilzomib, cyclophosphamide and dexamethasone (CCD) vs cyclophosphamide, Velcade and dexamethasone (CVD) for first relapse in myeloma patients.
OPENRecruiting patients
MUK six
Panobinostat(Novartis)
A Phase I/IIa trial of Velcade, thalidomide and dexamethasone (VTD) with panobinostat in relapsed and relapsed/refractory multiple myeloma patients who have received 1-4 prior lines of therapy.
OPENRecruiting patients
to Phase I
Pomalidomide(Celgene)
Pomalidomide Specific Targeting in Relapsed and Refractory Myeloma (POST Study). A single arm Phase II study in which all patients will receive treatment with Pomalidomide and Dexamethasone.
Expected to open 3Q2013
HJM UKMF Spring Day – 13 March 2013
CI and Co-Investigators
Study Drug CI Co-investigator
MUK one Bendamustine SSchey J Cavet
MUK three CHR3996 & Tosedostat FDavies GMorgan & KYong
MUK four Vorinostat FDavies CWilliams & JCavet
MUK five Carfilzomib KYong GMorgan & CWilliams
MUK six Panobinostat JCavenagh GMorgan & KYong
MUK Pomalidomide GMorgan FDavies & GCook
HJM UKMF Spring Day – 13 March 2013
Linking the CTN with Discovery Research
Diagnostics
Biobanking
Clinical Trial Network
Myeloma ResearchCentres
Personalised MedicineProgramme
HJM UKMF Spring Day – 13 March 2013
Why the MUK CTN important
Patients are waiting…
Myeloma patients need more effective treatments with less side-effects.
In order to deliver this in the soonest possible time frame, we have set upthe CTN to be more efficient and more effective.
We must challenge the hurdles and the inefficiencies and strive for improvements in the system.
HJM UKMF Spring Day – 13 March 2013
“Our Clinical Trial Network is a groundbreaking approach to clinical research in the UK. It is strategic, efficient and collaborative. Our model of engaging with stakeholders and breaking down barriers is not only changing the course of myeloma research, but could transform the way in which new treatments for other rare cancers are tested and accessed.”
Eric Low OBE, CEO Myeloma UK