Early Phase
Clinical Trial Network
UKMF Spring Day
- 13 March 2013
HJM
UKMF Spring Day – 13 March 2013
CTN Objectives
Strategic
The most pertinent clinical studies are identified based on Key Objectives and developed
and prioritised by a Steering Group of myeloma specialists.
Collaborative
Stakeholders 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.
Efficient
Working 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
HJM
UKMF Spring Day – 13 March 2013
Leeds Clinical Trials
Coordinating Office
CTN Network
Leeds Clinical Trials
Coordinating Office
Central Trial Office
8 Core Active
Trial Centres
4 Additional
Centres
St James’s,
Leeds
City,
Nottingham
QE,
Birmingham
The Christie,
RMH,
London
UCLH,
London
King’s,
London
Bart’s,
London
R Hallamshire General H, Uni H Wales,
Sheffield
Southampton
Cardiff
Expansion
inc. Scotland
& N Ireland
HJM
UKMF Spring Day – 13 March 2013
Manchester
Uni Hospital,
Oxford
CTN is part of a wider objective
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.
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
HJM
UKMF Spring Day – 13 March 2013
Strategic Approach to Selecting Trials
CTN trials are identified and prioritised based on two objectives:
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
HJM
•
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
UKMF Spring Day – 13 March 2013
Current Portfolio of MUK Trials
MUK
No.
HJM
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.
OPEN
Recruiting 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.
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.
OPEN
Recruiting 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.
OPEN
Recruiting 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.
UKMF Spring Day – 13 March 2013
Expected to open
2Q 2013
Expected to open
3Q2013
CI and Co-Investigators
HJM
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
UKMF Spring Day – 13 March 2013
Linking the CTN with Discovery Research
Biobanking
Personalised Medicine
Programme
Clinical Trial Network
Myeloma Research
Centres
Diagnostics
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 up
the 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
HJM
UKMF Spring Day – 13 March 2013
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Heather McKinnon - UK Myeloma Forum