STUDIENLISTE August2018 Studien offen für Accrual DIM Onkologie/Hämatologie und Brustzentrum Kantonsspital St. Gallen

Size: px

Start display at page:

Download "STUDIENLISTE August2018 Studien offen für Accrual DIM Onkologie/Hämatologie und Brustzentrum Kantonsspital St. Gallen"

Alfred Montgomery
5 years ago
Views:

1 / L E U K Ä M I E SAKK GRAALL SAKK 30/10 Hovon 103 Selinexor Multicenter trial for the treatment of Acute Lymphoblastic Leukemia (ALL) in younger adults (18-59 years) A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral selinexor (KPT- 330) to standard induction chemotherapy in AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) in patients aged 66 years SAKK CLL-13 SAKK CLL-13: A phase 3 multicenter, randomized, prospective, open-label trial of standard chemoimmunotherapy (FCR/BR) versus rituximab plus venetoclax (RVe) versus obinutuzumab (GA101) plus venetoclax (GVe) versus obinutuzumab plus ibrutinib plus venetoclax (GIVe) in fit patients with previously untreated chronic lymphocytic leukemia (CLL) without del(17p) or TP53 mutation (GAIA Trial) MDS 14 Multicentre Observational Study of MDS Patients in Switzerland Swiss MDS Registry Blincyto An Observational Study of Blinatumomab Safety and Effectiveness, Utilisation, and Treatment Practices 10/060 13/082 L Y M P H O M T-Zell* IELSG 37 Prospektive Datenerhebung bei Patientinnen und Patienten mit peripheren T-Zell Non- Hodgkin Lymphomen A randomized, open-label, multicentre, twoarm 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) 15/033 SAKK 36/13 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 / Start Phase II am /104 SAKK 35/14 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 SAKK 35/15 A phase I trial of obinutuzumab in combination with venetoclax in previously untreated follicular lymphoma patients SAKK HD 21 Treatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma; comparison of 6 cycles of escalated BEACOPP with 6 cycles of BrECADD SAKK TRIANGLE TRIANGLE: autologous Transplantation after a Rituximab/Ibrutinib/Ara-c containing induction in Generalized mantle cell Lymphoma a randomized European MCL Network trial M A M M A Adjuvant TAXIS 23/16 SAKK 23/16 Tailored AXIllary Surgery with or without axillary lymph node dissection followed by radiotherapy in patients with clinically node- U.Hess Urs.hess@kssg.ch M.Baumann Michael.baumann@zlmsg.ch M.Fehr Martin.fehr@kssg.ch F. Hitz M.Knauer Michael.Knauer@kssg.ch K.Knöpel P.Caminada / T.Zeller Studienliste August2018 /kk/jn (ersetzt Liste Juli 2018) Seite 1 von 5

2 PALLAS (IBCSG) 14/158 POSITIVE IBCSG positive breast cancer. A multicenter randomized phase III trial (TAXIS) PALLAS: PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer A study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer BLADDER SAKK 06/17 Neoadjuvant and adjuvant durvalumab in combination with neoadjuvant chemotherapie in patients with operable urothelial cancer. A multicentre,single-arm phase II trial BAY17403 A randomized, open label, multicenter, seamless Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY ) compared to chemotherapy in patients with FGFRpositive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy Metastasierend P. Weder Patrik.weder@kssg.ch S.Riniker Salome.riniker@kssg.ch S.Schmied Sabine.Schmid@kssg.ch S.Schmied Sabine.Schmid@kssg.ch T.Zeller/ T.Zeller/ J. Niedermann 14/057 SAKK 96/12* 15/026 SAKK 25/14 Eribulin as 1st line treatment in elderly patients ( 70 years) with advanced breast cancer: a multicenter phase II trial / SAKK 24/14 Anti-EGFR-immunoliposomes loaded with doxorubicin in patients with advanced triple negative EGFR positive breast cancer A multicenter single arm phase II trial Prevention of Symptomatic Skeletal Events with Denosumab Administered every 4 Weeks versus every 12 Weeks A Non- Inferiority Phase III Trial PB_ L U N G E MK ; PEARLS 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 SAKK 16/14 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 SAKK19/16 Binimetinib, pemetrexed and cisplatin, followed by maintenance with binimetinib and pemetrexed, in patients with advanced non-small cell lung cancer with KRAS mutations: A multicenter phase IB trial BOOSTER ETOP BOOSTER: A randomised phase II trial of osimertinib and bevacizumab versus osimertinib alone as second-line treatment in stage IIIb-IVb NSCLC with confirmed EGFRm and T790M SAKK 17/16 Lurbinectedin Monotherapy in Patients with Progressive Malignant Pleural S.Schmid Sabine.schmid@kssg.ch U.Hasler-Strub Ursula.hasler-strub@kssg.ch U.Hasler Ursula.hasler-strub@kssg.ch L.Allenspach/ L.Allenspach/ Studienliste August2018 /kk/jn (ersetzt Liste Juli 2018) Seite 2 von 5

3 Mesothelioma. A Multicenter, Single-arm Phase II Trial MERU A Randomized, Double-Blind, Placebo- Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer M16-298(MERU) K O L O N / R E K T A L 15/127 SAKK 41/13 Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients. A randomized, double-blinded, placebocontrolled, phase III trial PhenoTox Hunting the missing heritability of early-onset fluoropyrimdine-related toxicity in cancer 15/156 SAKK 41/14 patients: an observational multi-center study. Protocol SAKK 41/14 ACTIVE-2 Physical activity program in patients with metastatic colorectal cancer who receive palliative firstline chemotherapy. A multicenter open label randomized controlled phase III trial C.Appenzeller Christina.appenzeller@kssg.ch U. Güller Ulrich.gueller@kssg.ch D.Horber Daniel.horber@kssg.ch SAKK 41/16 RECAP Neoadjuvant treatment with Regorafenib and Capecitabine combined with radiotherapy in locally advanced rectal cancer. A multicenter phase Ib trial (RECAP). O E S O P H A G E A L BMS CA SAKK PRODIGE 32 A Randomized, Multicenter, Double Blind, Phase III Study of Nivolumab or Placebo in Subjects with Resected Lower Esophageal, or Gastroesophageal Junction Cancer Systematic surgery vs monitoring and salvage surgery in operable oesophageal cancer in complete clinical response after chemoradiation Strategic multicenter randomized phase II- III trial N I E R E SAKK 07/17 Nivolumab in combination with Ipilimumab in patients with metastatic renal cell carcinoma: A multicentre single-arm phase li trial 14/057 P R O S T A T A SAKK 96/12* SAKK 08/14 IMPROVE Prevention of Symptomatic Skeletal Events with Denosumab Administered every 4 Weeks versus every 12 Weeks A Non- Inferiority Phase III Trial Investigation of Metformin in patients with castration resistant prostate cancer in combination with Enzalutamide vs. Enzalutamide alone A randomized, open label, phase II trial 14/143 EORTC 1333 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 14/155 PRO-PLAT Single arm open lable phase II pilot study of Carboplatin in patients with metastatic castration-resistant prostate cancer (CRPC) and PTEN-LOSS Ch.Weisshaupt Christian.weisshaupt@kssg.ch Th.Ruhstaller Thomas.ruhstaller@kssg.ch C.Rothermundt S.Schmid Sabine.schmid@kssg.ch Ch.Rothermundt Aurelius.Omlin@kssg.ch F.Hutter/ Studienliste August2018 /kk/jn (ersetzt Liste Juli 2018) Seite 3 von 5

4 MK Pembro Prostata 13/ BMS CA /061 P H A S E I S T U D I E N Bayer An open label, non-randomized, Phase I dose escalation study to characterize safety, tolerability, pharmacokinetics and maximum tolerated dose of BAY in subjects with refractory, locally advanced or metastatic solid tumors A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS Administered Alone and in Combination with Nivolumab (BMS , anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors SAKK 67/15 BASILEA Phase II Trial of Pembrolizumab (MK-3475) in Subjects with Metastatic Castration- Resistant Prostate Cancer (mcrpc) Previously Treated with Chemotherapy (KEYNOTE-199) SAKK 08/16 ODM-201 maintenance therapy in patients with metastatic castration resistant prostate cancer (mcrpc) previously treated with one novel hormonal agent first line and nonprogressive disease after second line treatment with a taxane: A multicenter randomized double-blind placebo-controlled phase II trial Bayer An open-label, first-in human, doseescalation study to evaluate the safty tolerability, pharmacokinetics, pharmacodynamics and maximum tolerated dose and/ o recommended Phase II dose of the ATR inhibitor BAY in patients with advanced solid tumors and lymphomas. 13/083 12/091 12/125 H O D E N K R E B S SAG TCCS Prospektive Datenerhebung bei Patienten mit Hodenkrebs P A L L I A T I V M E D I Z I N EORTC Development of a module to supplement the Cachexia EORTC Core instruments for assessment of module 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 13/157 IZERZO Romanian-Swiss Research Program IZERZO: Reality Map of integrated oncology and palliative care in Romanian and Swiss Cancer centres Temporarily closed for Accrual MENTOR Pilotierung eines Ratgebers für Patienten mit fortgeschrittenen Tumorerkran-kungen mit zusätzlicher Dokumentation der individuellen Bedürfnisse im Rah-men der MENTOR-Studie MENAC A randomised, open-label trial of a Multimodal Intervention (Exercise, Nutrition and Antiinflammatory Medication) plus standard care versus standard care alone to prevent / attenuate cachexia in advanced cancer patients undergoing chemotherapy An open-label Phase 1/2a study of BAL administered as intravenous 48-hour infusion in adult patients with advanced solid tumors Aurelius.Omlin@kssg.ch Markus.Joerger@kssg.ch Ch.Rothermundt,, florian.strasser@kssg.ch temp.closed ab J. Niedermann J.Niederman N.Behnke/ L. Allenspach/ F.Hutter/ Studienliste August2018 /kk/jn (ersetzt Liste Juli 2018) Seite 4 von 5

5 MP0274 A phase 1, first-in-human, single-arm, multicenter, open-label, repeated-dose, dose escalation study to assess safety, tolerability, and pharmacokinetics of MP0274 in patients with advanced HER2-positive solid tumors NIR178 A Phase 2, multi-center, open label study of NIR178 in combination with PDR001 in patients with selected advanced solid tumors and non-hodgkin lymphoma /190 Bayer An open-label, first-in-human, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose and / or recommended Phase II dose of the ATR inhibitor BAY in patients with advanced solid tumors and lymphomas. A N D E R E Zur Zeit keine offen für Accrual Die Studienliste ist abrufbar auf M.Joerger M.Joerger *Diese Studien können grösstenteils auswärts durchgeführt werden. Studienliste August2018 /kk/jn (ersetzt Liste Juli 2018) Seite 5 von 5

STUDIENLISTE Februar 2018 Studien offen für Accrual DIM Onkologie/Hämatologie und Brustzentrum Kantonsspital St. Gallen. fett = neu Zuständigkeit

STUDIENLISTE Februar 2018 Studien offen für Accrual DIM Onkologie/Hämatologie und Brustzentrum Kantonsspital St. Gallen. fett = neu Zuständigkeit 15/193 2016-00548 L E U K Ä M I E SAKK GRAALL 2014 Multicenter trial for the treatment of Acute Lymphoblastic Leukemia (ALL) in younger adults (18-59 years) 2017-00372 SAKK CLL-13 SAKK CLL-13: A phase