STUDIENLISTE Juni 2015 Studien offen für Accrual DIM Onkologie/Hämatologie und Brustzentrum Kantonsspital St. Gallen fett = neu Zuständigkeit Arzt/Ärztin Clinical Research Coordinator (CRC) / Studiensekretariat LEUKÄMIE EKSG 08/043 SAKK APL2006 EKSG 14/113 SAKK 30/10 Hovon 103 TOS EKSG 14/094 SAKK 30/13 Hovon 132 A randomized phase III trial assessing the role of arsenic trioxide and/or ATRA during consolidation course in newly diagnosed acute promyelocytic leukemia (APL) 11.12.2013 Arm A für Accrual geschlossen A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral tosedostat to standard induction therapy in AML and RAEB ≥ 66 years and very poor risk AML ≥ 18 year 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). F.Hitz J.Kehl / J.Frehner U. Hess B.Pfister / K.Knöpfel U. Hess B.Pfister / K.Knöpfel Therapieoptimierungsstudie in der Primärtherapie des frühen Hodgkin Lymphoms: Therapiestratifizierung mittels FDG-PET 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 A phase I study of Inotuzumab Ozogamicin (CMC-544) in combination with Temsirolimus (CCI-779) in patients with relapsed or refractory CD22-positive B-cell Non Hodgkin’s Lymphomas 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) F.Hitz Y.Wittwer / K.Knöpfel B.Meehan/ K.Knöpfel F. Hitz B.Künzle / J.Frehner Nelfinavir and lenalidomide/dexamethasone in patients with progressive multiple myeloma that have failed lenalidomidecontaining therapy. A single arm phase I/II trial Nelfinavir as bortezomib-sensitizing drug in patients with proteasome inhibitor-nonresponsive myeloma. A multicenter phase II trial. F.Hitz E.Veres / J.Frehner C.Driessen A.Peter / K.Knöpfel 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 / J.Frehner Randomisierte Phase-II-Studie mit Pertuzumab in Kombination mit Trastuzumab mit oder ohne Chemotherapie, beide gefolgt von TDM1 im Falle eines Fortschreitens der Krankheit bei Patientinnen mit HER2-positivem metastasierenden Brustkrebs A randomized phase II study evaluating different schedules of nab-Paclitaxel in metastatic breast cancer A Phase I 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 Temporarily closed for Accrual Prevention of Symptomatic Skeletal Events with Denosumab Administered every 4 Weeks versus every 12 Weeks – A NonInferiority Phase III Trial P.Weder Aline Peter / K.Knöpfel U. Hasler-Strub C.Böhme / J.Frehner E.Veres / J.Frehner LYMPHOM EKSG 10/088 EKSG 13/014 SAKK HD 16* EKSG 10/060 EKSG 12/013 T-Zell* EKSG 13/082 IELSG 37 SAKK HD 17* IOSI-Study F.Hitz F.Hitz F.Hitz R.Demmer / J.Frehner B.Pfister / J.Frehner MYELOMA EKSG 11/053 SAKK 39/10 EKSG 14/082 SAKK 39/13* Fortune MAMMA Adjuvant EKSG 12/154 EORTC 10085* EKSG 15/013 SAKK 23/13 EKSG 14/158 POSITIVE IBCSG 48-14 Metastasierend EKSG 12/164 SAKK 22/10* EKSG 13/095 EKSG 14/007 IBCSG 42-12* EKSG 14/057 SAKK 96/12* SAKK 21/12 Studienliste Juni 2015 SG/kk/jf (ersetzt Liste Mai 2015) S.Riniker A.Templeton Franziska Hutter/ K.Knöpfel Seite 1 von 3 STUDIENLISTE Juni 2015 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 / J.Frehner S.Riniker J.Kehl / J.Frehner A Phase Ib/II, multicenter, open-label, dose escalation study of LGX818 in combination with MEK162 in adult patients with BRAF V600 - dependent advanced solid tumors A. Omlin A.Peter / J.Frehner Phase II study to investigate the efficacy of panitumumab in platinum-resistant advanced head and neck squamous cancer. Temporarily closed for Accrual M.Siano B.Meehan / J.Frehner Avastin plus Radiotherapy in Elderly Patients with Glioblastoma (ARTE) A phase II, randomized, parallel-group, explorative, open labeled multi-center study of bevacizumab (Avastin) in elderly subjects with newly diagnosed glioblastoma A phase Ib/II, open-label, multicenter study of INC280 administered orally in combination with BKM120 in adult patients with recurrent glioblastoma multiforme L. Plasswilm / Th.Hundsberger B.Pfister / J.Frehner M.Jörger / Th.Hundsberger C.Frey / J.Frehner Preoperative chemotherapy and radiotherapy concomitant to Cetuximab in nonsmall cell lung cancer (NSCLC) patients with IIIB disease. A multicenter phase II trial. A phase III, multicenter, randomized, open-label study of oral LDK378 versus standard chemotherapy in adult patients with ALKrearranged (ALK-positive) advanced non-small cell lung cancer who have been treated previously with chemotherapy (platinum doublet) and crizotinib Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) M.Früh / M.Siano B.Meehan / K.Knöpfel M.Früh C.Frey / J.Frehner M. Jörger B.Pfister / J.Frehner Pharmacogenetics and therapeutic drug monitoring for the optimization of fluoropyrimidine treatment in patients with advanced colorectal cancer. M.Jörger A.Peter / J.Frehner Serum and tissue biomarkers in patients with early and advancedstage renal-cell carcinoma M.Jörger Y.Wittwer / J.Frehner A phase III, open-label, multicenter, randomized study to investigate the efficacy and safety of MPDL3280A (ANTI−PD-L1 ANTIBODY) compared with chemotherapy in patients with locally advanced or metastatic urothelial bladder cancer after failure with platinum-containing chemotherapy. GO29294 S. Gillessen C.Frey / J.Frehner 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 S.Gillessen B.Meehan / J.Frehner Ch. Rothermundt B.Meehan / J.Frehner MELANOM EKSG 14/087 CMEK HNO EKSG 10/133 PANI01 GEHIRN EKSG 11/127 ARTE EKSG 13/106 INC280 LUNGE EKSG 09/137 SAKK 16/08 EKSG 13/088 LDK378 EKSG 14/093 M11-089 Veliparip KOLON / REKTUM EKSG 12/110 FLOXTOX II NIERE EKSG 11/140 Proteomics BLASE/HARNWEGE EKSG 15/016 MPDL Uro PROSTATA EKSG 11/070 VMT-VT-464CL-001 EKSG 13/019 MetAb-Pro Studienliste Juni 2015 SG/kk/jf (ersetzt Liste Mai 2015) Seite 2 von 3 STUDIENLISTE Juni 2015 Studien offen für Accrual DIM Onkologie/Hämatologie und Brustzentrum Kantonsspital St. Gallen fett = neu Zuständigkeit Arzt/Ärztin EKSG 14/014 EKSG 14/037 EKSG 14/057 SG 371/14 Collection of Clinical Material from Patients with Castration Resistant Metastatic Prostate Cancer – A Feasibility Study A.Omlin CAINTA Randomized phase II CAbazitaxel dose Individualization and Neutropenia prevention TriAl (CAINTA), M.Jörger SAKK 96/12* A.Templeton EKSG 13/083 EKSG 14/155 SAG TCCS Prevention of Symptomatic Skeletal Events with Denosumab Administered every 4 Weeks versus every 12 Weeks – A NonInferiority Phase III Trial Prospektive Datenerhebung bei Patienten mit Hodenkrebs Single arm open lable phase II pilot study of Carboplatin in patients with metastatic castration-resistant prostate cancer (CRPC) and PTEN-LOSS A.Omlin PRO-PLAT Clinical Research Coordinator (CRC) / Studiensekretariat Ch.Rothermundt F.Hutter / K.Knöpfel B.Meehan / J.Frehner Franziska Hutter/ K.Knöpfel J.Kehl / J.Frehner F.Hutter / J.Frehner PALLIATIVMEDIZIN EKSG 12/091 EORTC Cachexia module EKSG 12/125 EKSG 13/157 IZERZO F.Strasser S. AttounKnobel/ J.Frehner F.Strasser, N.MagayaKalbermatten F.Strasser, N.MagayaKalbermatten N.Behnke / J.Frehner Phase I, multi-center, non-randomized, open-label, dose escalation design study to characterize safety, tolerability, pharmacokinetics and maximum tolerated dose of BAY 1125976 in subjects with advanced solid tumors 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 D.Hess Y.Wittwer / K.Knöpfel M.Jörger B.Künzle / K.Knöpfel 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.Omlin B Meehan/ K.Knöpfel Cytochrom p450 3A4 and 1A2 phenotyping for the individualization of treatment with sunitinib or erlotinib in cancer patients M.Jörger B.Pfister / J.Frehner 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 / J.Frehner PHASE I–STUDIEN EKSG 13/064 Bayer 16447 EKSG 13/105 Bayer 16443 EKSG 14/098 MP0250 ANDERE EKSG 11/054 Cytochrom p450 Die Studienliste ist abrufbar auf http://www.onkologie.kssg.ch/home/forschung/forschungsabteilung/studienliste.html *Diese Studien können grösstenteils auswärts durchgeführt werden. Studienliste Juni 2015 SG/kk/jf (ersetzt Liste Mai 2015) Seite 3 von 3
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