STUDIENLISTE Juli 2016
Studien offen für Accrual
DIM Onkologie/Hämatologie und Brustzentrum Kantonsspital St. Gallen
fett = neu
Zuständigkeit
Arzt/Ärztin
Clinical Research
Coordinator (CRC) /
Studiensekretariat
LEUKÄMIE
EKSG
14/094
SAKK 30/13
Hovon 132
EKSG
15/193
/
PB_20
160058
SAKK GRAALL
2014
Randomized study with a run-in dose-selection phase to assess
the added value of lenalidomide in combination with standard
remission-induction chemotherapy and post-remission treatment
in patients aged 18-65 years with previously untreated acute
myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSSR risk score > 4.5).
Multicenter trial for the treatment of Acute Lymphoblastic
Leukemia (ALL) in younger adults (18-59 years)
U.Hess
B.Pfister /
K.Knöpfel
T. Silzle
M. Donno /
L.
Schneider
Therapieoptimierungsstudie in der Primärtherapie des
intermediären Hodgkin Lymphoms: Therapiestratifizierung mittels
FDG-PET
Prospektive Datenerhebung bei Patientinnen und Patienten mit
peripheren T-Zell Non-Hodgkin Lymphomen
F.Hitz
B.Meehan/
K.Knöpfel
F.Hitz
A randomized, open-label, multicentre, two-arm phase III
comparative study assessing the role of mediastinal radiotherapiy
after Rituximab containing chemotherapy regimens to patients
with newly diagnosed Prinamry Mediastinal Large B-Cell
Lymphoma (PMLBCL)
Combination of ibrutinib and bortezomib followed by ibrutinib
maintenance to treat patients with relapsed and refractory mantle
cell lymphoma; a multicenter Phase I/II trial
Rituximab with or without Ibrutinib for untreated patients with
advanced follicular lymphoma in need of therapy. A randomized,
double-blinded, SAKK and NLG collaborative Phase II trial
F.Hitz
R.Demmer
/
L.Schneide
r
B.Künzle /
L.Schneide
r
LYMPHOM
EKSG
13/014
SAKK HD 17*
EKSG
10/060
T-Zell*
EKSG
13/082
IELSG 37
EKSG
15/033
SAKK 36/13
EKSG
15/104
SAKK 35/14
C.Driessen
Y.WittwerL.
Schneider
F.Hitz
B. Künzle
L.Schneide
r
Nelfinavir and lenalidomide/dexamethasone in patients with
progressive multiple myeloma that have failed lenalidomidecontaining therapy. A single arm phase I/II trial
F.Hitz
E.Veres /
L.Schneide
r
Clinical and biological characterization of Male Breast Cancer: an
international retrospective EORTC, BIG and NABCG intergroup
study (temporarily closed)
Impact of a Surgical Sealing Patch on Lymphatic Drainage after
Axillary Lymph Node Dissection for Breast Cancer. A Multicenter
Randomized Phase III Trial
A study evaluating the pregnancy outcomes and safety of
interrupting endocrine therapy for young women with endocrine
responsive breast cancer
S.Riniker
R.Demmer
/ K.Knöpfel
F.Chiesa
F.Hutter /
K.Knöpfel
S.Riniker
R.Demmer
/
L.Schneide
r
A Phase I / II and stratified, multicenter Phase II trial of
transdermal CR1447 (4-OH-testosterone) in endocrine
responsive-HER2 negative and triple negative-androgen receptor
positive metastatic or locally advanced breast cancer Since
04.05.2016 open for Accrual Phase II
Prevention of Symptomatic Skeletal Events with Denosumab
Administered every 4 Weeks versus every 12 Weeks – A NonInferiority Phase III Trial
Eribulin as 1st line treatment in elderly patients (≥ 70 years) with
advanced breast cancer: a multicenter phase II trial / Temporarily
closed for Accrual!
A Phase III, MULTICENTER, RANDOMIZED, placebo-controlled
Study OF Atezolizumab (AntiPD-L1 Antibody) IN COMBINATION
WITH NAB-PACLITAXEL COMPARED with placebo with
NAB-PACLITAXEL for PATIENTS WITH previously UNtreated
metastatic TRIPLE-NEGATIVE BREAST CANCER
S.Riniker
E.Veres /
L.Schneider
MYELOMA
EKSG
11/053
SAKK 39/10
MAMMA
Adjuvant
EKSG
12/154
EORTC 10085*
EKSG
15/013
SAKK 23/13
EKSG
14/158
POSITIVE
IBCSG 48-14
Metastasierend
EKSG
14/007
SAKK 21/12
EKSG
14/057
SAKK 96/12*
EKSG
15/026
SAKK 25/14
201600214
WO29522
Impassion
Studienliste Juli 2016 SG/kk/ls (ersetzt Liste Juni 2016)
S. Gillessen
U.Hasler-Strub
P. Weder
L.Allenpac
h/
K.Knöpfel
F.Hutter /
L.Schneide
r
L.
Allenspach
/ L.
Schneider
Seite 1 von 3
STUDIENLISTE Juli 2016
Studien offen für Accrual
DIM Onkologie/Hämatologie und Brustzentrum Kantonsspital St. Gallen
fett = neu
Zuständigkeit
Arzt/Ärztin
Clinical Research
Coordinator (CRC) /
Studiensekretariat
OVAR
EKSG
14/025
Mito-Mango*
EKSG
14/047
INOVATYON*
A multicentre phase III randomized study with second line
chemotherapy plus or minus bevacizumab in patients with
platinum sensitive epithelial ovarian cancer recurrence after a
bevacizumab/chemotherapy first line.
Phase III international, randomized study of Trabectedin plus
Pegylated Liposomal Doxorubicin (PLD) versus Carboplatin plus
PLD in patients with ovarian cancer progressing within 6-12
months of last platinum
P.Weder
E.Veres /
L.Schneide
r
S.Riniker
J.Kehl /
L.Schneide
r
Adjuvant immunotherapy with anti-PD-1 monoclonal antibody
Pembrolizumab (MK-3475) versus placebo after complete
resection of high-risk Stage III melanoma: A randomized, doubleblind Phase 3 trial of the EORTC Melanoma Group.
M. Fehr
F. Hutter /
L.
Schneider
A phase Ib/II, open-label, multicenter study of INC280
administered orally in combination with BKM120 in adult patients
with recurrent glioblastoma multiforme. Temporarily closed for
Accrual since 02.05.16
M.Jörger /
Th.Hundsberger
C.Frey /
L.Schneide
r
A randomized, phase 3 trial with anti-PD-1 monoclonal antibody
pembrolizumab (MK-3475) versus placebo for patients with early
stage NSCLC after resection and completion of standard adjuvant
therapy
A phase III, open-label, randomized study of MPDL3280A
(AntiPD-L1 antibody) in combination with carboplatin Paclitaxel
with or without bevacizumab compared with
carboplatin Paclitaxel bevacizumab in chemotherapy-naïve
patients with stage IV non-squamous non-small cell lung cancer
Anti-PD-L1 antibody MEDI4736 in addition to
neoadjuvant chemotherapy in patients with stage
IIIA(N2) non-small cell lung cancer (NSCLC).
A multicenter single-arm phase II trial.
M. Früh
B. Künzle /
L.
Schneider
M. Früh
K.Klag /
K.Knöpfel
M. Früh
L.
Allenspach
/ K.
Knöpfel
MELANOM
EKSG
15/091
Merck EORTC
1325 / MK-3475054
GEHIRN
EKSG
13/106
INC280
LUNGE
PB_20
1600306
MK-3475-091;
PEARLS
EKSG
15/072
GO29436
IMPower
201500042
SAKK 16/14
KOLON/REKTAL
EKSG
15/127
SAKK 41/13
Adjuvant aspirin treatment in PIK3CA mutated colon cancer
patients. A randomized, double-blinded, placebo-controlled,
phase III trial.
U. Güller
J. Kehl / L.
Schneider
201600061
PembroColon
MK3475-177
A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy
in Microsatellite Instability-High (MSI-H) or Mismatch Repair
Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177)
Ch. Weisshaupt
B. Pfister /
K.Knöpfel
Serum and tissue biomarkers in patients with early and advancedstage renal-cell carcinoma
M.Jörger
Y.Wittwer /
L.Schneide
r
A phase I / II open-label, multiple-dose study to evaluate the
safety, tolerability, pharmacokinetics and pharmacodynamics of
VT-464 in chemotherapy-naïve patients with castration-refractory
prostate cancer
Impact of the addition of metformin to arbiraterone in metastatic
castration-resistant prostate cancer patients progressing on
arbiraterone treatment (MetAb-Pro): A phase II pilot study
Collection of Clinical Material from Patients with Castration
Resistant Metastatic Prostate Cancer – A Feasibility Study
S.Gillessen
B.Meehan /
L.Schneide
r
Ch.
Rothermundt
B.Meehan /
L.Schneide
r
F.Hutter /
K.Knöpfel
B.Meehan /
L.Schneide
r
L.Allenspa
ch/ L.
Allenspach
/ K.Knöpfel
NIERE
EKSG
11/140
Proteomics
PROSTATA
EKSG
11/070
VMT-VT-464CL-001
EKSG
13/019
MetAb-Pro
EKSG
14/014
EKSG
14/037
SG 371/14
CAINTA
Randomized phase II CAbazitaxel dose Individualization
and Neutropenia prevention TriAl (CAINTA),
M.Jörger
EKSG
14/057
SAKK 96/12*
Prevention of Symptomatic Skeletal Events with Denosumab
Administered every 4 Weeks versus every 12 Weeks – A NonInferiority Phase III Trial
S.Gillessen
Studienliste Juli 2016 SG/kk/ls (ersetzt Liste Juni 2016)
A.Omlin
Seite 2 von 3
STUDIENLISTE Juli 2016
Studien offen für Accrual
DIM Onkologie/Hämatologie und Brustzentrum Kantonsspital St. Gallen
fett = neu
Zuständigkeit
Arzt/Ärztin
201600127
SAKK 08/14
IMPROVE
EKSG
14/143
EORTC 1333
EKSG
14/155
PRO-PLAT
EKSG
15/132
Abi-RE
Clinical Research
Coordinator (CRC) /
Studiensekretariat
Investigation of Metformin in patients with castration resistant
prostate cancer in combination with Enzalutamide vs.
Enzalutamide alone A randomized, open label, phase II trial
A Randomized multicenter phase III trial comparing enzalutamide
vs. a combination of Ra223 and enzalutamide in asymptomatic
or mildly symptomatic castration resistant prostate cancer patients
metastatic to bone. PEACE III
Single arm open lable phase II pilot study of Carboplatin in
patients with metastatic castration-resistant prostate cancer
(CRPC) and PTEN-LOSS
Ch. Rothermundt
M. Donno /
K. Knöpfel
S.Gillessen
R.Demmer
/ K.Knöpfel
A.Omlin
F.Hutter /
L.
Schneider
A.Omlin
C. Frey / L.
An Open Label Biomarker Driven Phase II Clinical Trial of Abiraterone Acetate (AA) Re-Challenge
Schneider
in Patients with Metastatic Castration-Resistant Prostate Cancer and Prior Response to AA
HODENKREBS
EKSG
13/083
SAG TCCS
Prospektive Datenerhebung bei Patienten mit Hodenkrebs
Ch.Rothermundt
EKSG
MicroRNA
miR-371a-3p neuer Serum-Biomarker bei Keimzelltumoren:
eine multizentrische prospektive klinische Studie der
Interdisziplinären Arbeitsgruppe Hodentumoren
Deutschland ("German Testicular Cancer Study Group")
H. Reichegger
15/208
J.Kehl /
L.Schneide
r
L.
Allenspach
/ L.
Schneider
PALLIATIVMEDIZIN
EKSG
12/091
EORTC
Cachexia
module
EKSG
12/125
EKSG
13/157
IZERZO
F.Strasser
S. AttounKnobel/
L.Schneider
F.Strasser,
N.MagayaKalbermatten
F.Strasser,
N.MagayaKalbermatten
N.Behnke /
L.Schneider
An open label, non-randomized, Phase I dose escalation study to
characterize safety, tolerability, pharmacokinetics and maximum
tolerated dose of BAY 1163877 in subjects with refractory, locally
advanced or metastatic solid tumors
A phase I multi-centre, open-label, repeated-dose, doseescalation study to assess safety, tolerability and pharmacokinetics of MP0250 in patients with advanced solid tumours
A Phase 1 Study to Investigate the Safety, Pharmacokinetic
Profiles and the Efficacy of EDO-S101, a First-in-Class Alkylating
Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in
Relapsed/Refractory Hematologic Malignancies
M.Jörger
B.Künzle /
K.Knöpfel
A.Omlin
B Meehan/
K.Knöpfel
Ch Driessen
B.
Meehan/K.
Knöpfel
Development of a module to supplement the EORTC Core
instruments for assessment of Health Related Quality of Life in
patients with Cancer Cachexia Temporarily on hold
Decision criteria guiding chemotherapy in palliative intention:
focusgroup based formal consensus for candidate criteria
Romanian-Swiss Research Program IZERZO: Reality Map of
integrated oncology and palliative care in Romanian and Swiss
Cancer centres Temporarily closed for Accrual
S.AttounKnobel /
L.Schneider
PHASE I–STUDIEN
EKSG
13/105
Bayer 16443
EKSG
14/098
MP0250
EKSG
15/189
Basec
201500091
EDO Phase I
ANDERE
EKSG
15/156
SAKK 41/14
Protocol SAKK 41/14 ACTIVE-2 Physical activity program
in patients with metastatic colorectal cancer who receive
palliative first-line chemotherapy. A multicenter open label
randomized controlled phase III trial
D. Horber
E. Veres /
K. Knöpfel
EKSG
15/031
AVA-CTP
S.Leschka
U.Güller
EKSG
15/063
BASKET
Visualization of anti-angiogenic effects with perfusion computed
tomography (CTP) in mCRC patients treated with first-line
bevacizumab (AVA-CTP)
Prospective, multi-center, single-arm clinical research trial
An open-label, multicohort, phase II study of MPDL3280A in
advanced solid tumors.
R.Demmer
/
L.Schneide
r
K.Klag /
L.Schneide
r
S.Gillessen
Die Studienliste ist abrufbar auf
http://www.onkologie.kssg.ch/home/forschung/forschungsabteilung/studienliste.html
*Diese Studien können grösstenteils auswärts durchgeführt werden.
Studienliste Juli 2016 SG/kk/ls (ersetzt Liste Juni 2016)
Seite 3 von 3
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