Performance in Delivery Research at RCHT
Name of Trial
Target
number
of
patients
Date
Agreed to
recruit
target
number of
patients
Trial Status
Target
met
within
the
agreed
time
12/LO/0482
PERUSE - A multicentre, open-label, single-arm study of pertuzumab in
combination with trastuzumab and a taxane in first line treatment with HER2postive advanced (metastatic or locally advanced recurrent) breast cancer.
5
31/03/2016
Closed - In Follow Up
Y
12/NW/0255
Comparing the efficacy of ipilimumab plus etoposide/platinum versus
etoposide/platinum in subjects with newly diagnosed extensive-stage disease
small cell lung cancer (ED-SCLC).
5
31/03/2016
Closed - In Follow Up
Y
12/EE/0176
Randomised, phase IV study to evaluate the efficacy and safety of tapering
methotrexate (MTX) dosage versus maintaining the dosage in patients with
rheumatoid arthritis who have an inadequate response to prior DMARDs.
10
31/03/2015
Closed - In Follow Up
Y
12/WA/0220
A phase III randomized, double blind placebo controlled study of BKM120
with fulvestrant, in postmenopausal women with hormone receptor-positive
HER2-negative locally advanced or metastatic breast cancer which
progressed after aromatase inhibition.
4
30/06/2014
Closed - Follow Up
Complete
Y
Research
Ethics
Committee
Reference
Number
Version PID Q3 2015-16
Review Due: 31/04/2016
Author: Nick Morley, Assistant Research Manager
Performance in Delivery Research at RCHT
11/SC/0169
Randomized, multi-center, double-blind, phase 3 trial comparing the efficacy
of ipilimumab in addition to paclitaxel and carboplatin versus placebo in
addition to paclitaxel and carboplatin in subjects with stage IV/recurrent
NSCLC.
5
30/06/2014
Closed - In Follow Up
N
12/LO/1981
A randomized, multi-centre, open label phase III study to evaluate the
efficacy and safety of Trastuzumab Emtansine vs Trastuzumab as adjuvant
therapy for patients with HER2-positive primary breast cancer who have
residual tumour present.
5
31/03/2016
Open
Y
13/LO/0105
Saizen in GHD of adult onset - open-label, single-arm, phase IV, multicentre
trial to explore the immunogenicity of the liquid formulation of Saizen in
subjects with GHD.
2
30/06/2014
Open
Y
12/LO/1876
Phase III vemurafenib vs vemurafenib + gdc-0973 in melanoma - a phase III,
double-blind, placebo-controlled study of vemurafenib versus venurafinib
plus GDC-0973 in previously untreated BRAFV600-mutation- positive
tumours.
5
31/01/2014
Closed - In Follow Up
N
13/LO/0258
PIONEER an open-label, randomized, controlled, multi-centre study exploring
two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin K
antagonist treatment strategy in subjects with atrial fibrillation.
7
31/03/2015
Open
Y
12/WS/0300
ODYSSEY a randomized, double-blind, placebo-controlled, parallel-group
study to evaluate the effect of SAR236553/REGN727 on the occurrence of
cardiovascular events in patients who have recently experienced an acute
coronary Syndrome.
25
31/03/2016
Closed - Follow Up
Complete
Version PID Q3 2015-16
Review Due: 31/04/2016
Author: Nick Morley, Assistant Research Manager
N/A
Performance in Delivery Research at RCHT
12/LO/950
A randomized, open-label, phase III trial of A+AVD versus ABVD as frontline
therapy in patients with advanced Classical Hodgkin Lymphoma.
5
27/11/2019
Open
11/NW/0298
A multicenter, phase III, open-label, randomized study in previously
untreated patients with advanced indolent non-hodgkin's lymphoma
evaluating the benefit of GA101 plus chemotherapy compared with rituximab
plus chemotherapy followed by GA101.
7
04/02/2014
Closed - In Follow Up
N
13/LO/0388
A phase III, multi-centre, randomized, double-blind placebo-controlled study
to assess the efficacy and safety of tocilizumab in subjects with giant cell
arteritis – GIACTA.
2
31/05/2014
Closed - In Follow Up
Y
13/NI/0072
A phase IV, open-label, single-arm study of Brentuximab Vedotin in patients
with relapsed or refractory systemic anaplastic large cell lymphoma.
2
01/09/2020
Open
N/A
13/LO/0720
A randomized phase III, open label, multi-centre, two-arm study comparing
the efficacy of MEK162 versus dacarbazine in patients with advanced
unresectable or metastatic NRAS mutation-positive melanoma.
3
31/12/2016
Open
N/A
13/NI/0093
A two part study to assess the safety and preliminary efficacy of Givinostat in
patients with JAK2V617F positive Polycythemia Vera.
1
01/02/2016
Open
Y
13/LO/0908
Medivation 11 A phase 2, single-arm, open-label, multi-centre study of the
clinical activity and safety of enzalutamide in patients with advanced,
androgen receptor-positive, triple-negative breast cancer.
2
27/06/2016
Open
Y
Version PID Q3 2015-16
Review Due: 31/04/2016
Author: Nick Morley, Assistant Research Manager
N/A
Performance in Delivery Research at RCHT
13/EM/0460
A randomized, multicenter, open-label, phase III trial comparing trastuzumab
plus pertuzumab plus a taxane versus trastuzumab emtansine plus
pertuzumab following anthracyclines as adjuvant therapy in patients with
operable her2-positive primary breast cancer.
8
31/12/2016
Open
Y
13/YH/0282
Openlabel, Phase IIIb study to evaluate the efficacy and safety of
subcutaneous (SC) Tocilizumab with methotrexate (MTX) in patients with
severe Rheumatoid Arthritis (RA).
10
01/08/2016
Closed - In Follow Up
N
13/LO/1720
A phase II, randomized, double-blind, placebo-controlled, multi-centre study
of efficacy and safety of enzalutamide in combination with exemestane in
patients with advanced breast cancer.
10
28/03/2016
Open
N/A
14/SC/0065
A randomized, multi centre, double-blind, parallel, placebo-controlled study
of the effects of canagliflozin on renal endpoints in adult subjects with type 2
diabetes mellitus.
6
30/05/2017
Open
Y
14/WS/0109
A randomized double-blind, placebo-controlled study of LEE011 in
combination with letrozole for the treatment of postmenopausal women
with advanced breast cancer.
3
27/06/2016
Closed - In Follow Up
N
13/LO/1620
A Phase 1 Single & Multiple-ascending Dose, Safety, Tolerability and Pk Study
of SC Administered ALN-AT3SC in Hemophilia A or B Patients.
1
01/09/2018
Open
Y
Version PID Q3 2015-16
Review Due: 31/04/2016
Author: Nick Morley, Assistant Research Manager
Performance in Delivery Research at RCHT
14/NE/1145
15/EM/0021
A Randomized, DoubleBlind, Phase 2 Study of Ruxolitinib or Placebo in
Combination With Capecitabine in Subjects With Advanced HER2 negative
Breast Cancer.
A randomized, double blind, placebo controlled multicentre trial, examining
the effect of Natrox™ on the rates of healing for chronic diabetic foot ulcers
(TODFU2).
Version PID Q3 2015-16
Review Due: 31/04/2016
Author: Nick Morley, Assistant Research Manager
3
10/12/2015
Closed - In Follow Up
N
4
31/01/2016
Open
Y
Performance in Delivery Research at RCHT
08/H1008/25
Rheumatoid Arthritis Medication Study (RAMS): Predicting response to
DMARDs in Rheumatoid Arthritis
38
31/05/2011
Open
Y
14/LO/1798
A Phase III open-label multicenter randomised study to investigate the
efficacy and safety of Anti-PD-L1 antibody compared to chemotherapy
in patients with advanced bladder cancer
2
03/08/2016
Open
N/A
14/SC/0203
Real World Effectiveness Of Lixisenatide And Other Intensification
Therapy In The Management Of Type 2 Diabetic Patients Uncontrolled
With Basal Insulin
6
31/01/2019
Open
N/A
15/SC/0065
A Phase III, Open-label, Randomised, Multi-centre, International Study
of MEDI4736, Given as Monotherapy or in Combination with
Tremelimumab, Versus Standard of Care in Patients with Locally
Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV)
(ARCTIC)
3
28/09/2017
Open
N/A
15/NW/0152
A multicenter, open-label, single-arm safety study of Herceptin
Subcutaneous in combination with Perjeta and Docetaxel in treatment
of patients with HER2-Positive advanced breast cancer (metastatic or
locally recurrent)
3
01/02/2019
Open
N/A
15/SW/0086
A Phase 3 Study Comparing Daratumumab, Lenalidomide, and
Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in
Subjects with Previously Untreated Multiple Myeloma who are Ineligible
for High Dose Therapy
5
31/07/2022
Open
N/A
Version PID Q3 2015-16
Review Due: 31/04/2016
Author: Nick Morley, Assistant Research Manager
Performance in Delivery Research at RCHT
15/EM/0031
ReFLeCT: The REFLECT study will assess the real world safety in
terms of hypoglycemia and adverse events as well as effectiveness of
Tresiba® in routine care and the benefits to diabetes mellitus patients’
quality of life for patients.
6
31/08/2016
Open
N/A
15/LO/1006
An open-label, single-arm Phase II study in patients with relapsed or
refractory diffuse large B-cell lymphoma (DLBCL) to evaluate efficacy
and safety of treatment with single agent copanlisib and the impact of
biomarkers thereupon
2
30/06/2016
Open
N/A
15/NW/0015
A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of MEDI4736 as Sequential Therapy in
Patients with Locally.
2
28/10/2019
Open
N/A
15/LO/0564
Armor3-sv: a phase 3, randomized, open label, multicenter, controlled
study of galeterone compared to enzalutamide in men expressing
androgen receptor splice variant-7 mrna (ar-v7) metastatic (m1)
castrate resistant prostate cancer (crpc).
3
21/11/2017
Open
N/A
15/SC/0380
A randomised, double blind, dose–finding study comparing
semaglutide administered subcutaneously once daily to placebo and
liraglutide in patients diagnosed with Type 2 diabetes treated with diet
and exercise with or without metformin
5
17/10/2016
Open
N/A
15/NI/0128
Long-term study evaluating the effect of Givinostat in patients with
JAK2V617F positive chronic myeloproliferative neoplasms.
1
02/11/2016
Open
N/A
Version PID Q3 2015-16
Review Due: 31/04/2016
Author: Nick Morley, Assistant Research Manager
Performance in Delivery Research at RCHT
15/NI/0127
An open-label extension study of subcutaneously administered alnat3sc in patients with moderate or severe haemophilia a or b who have
participated in a previous clinical study with aln-at3sc
1
01/09/2017
Open
N/A
15/NW/0068
A Phase III, randomized, double-blind, placebo controlled multi-center
study of subcutaneous secukinumab (150 mg and 300 mg) in prefilled
syringe to demonstrate efficacy (including inhibition of structural
damage), safety, and tolerability up to 2 years in subjects with active
psoriatic arthritis.
5
31/10/2016
Open
N/A
Version PID Q3 2015-16
Review Due: 31/04/2016
Author: Nick Morley, Assistant Research Manager