Open Trials as of end of March 2016

Transcription

1 EORTC PRO EORTC prospective part, Clinical and biological characterization of Male Breast Cancer: an international EORTC, BIG and NABCG inter study Jun-2016 IBCSG POSITIVE A study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy (POSITIVE) Jun-2018 Breast IBCSG OLYMPIA A randomised, double-blind, parallel, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib vs placebo as adjuvant treatment in patients with high risk germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy Mar-2019 ibcsg50_olympia@fstrf.org SAKK 23/13 Impact of a Surgical Sealing Patch on Lymphatic Drainage after Axillary Lymph Node Dissection for Breast Cancer. A Multicenter Randomized Phase III Trial Dec-2016 estelle.cassoly@sakk.ch /8

2 SAKK 25/14 Eribulin as 1st line treatment in elderly patients (>= 70 years) with advanced breast cancer: a multicenter phase II trial Aug-2018 daniela.baertschi@sakk.ch SAKK 96/12 Prevention of Symptomatic Skeletal Events with Denosumab Administered every 4 Weeks versus every 12 Weeks A Non- Inferiority Phase III Trial (131 Breast) 16-Jan-2019 andrea.fuhrer@sakk.ch Gastrointestinal PROSPECT SAKK 41/14 A phase II/III trial of neoadjuvant folfox, with selective use of combined modality chemoradiation vs. preoperative combined modality chemoradiation for locally advanced rectal cancer patients undergoing low anterior resec-tion with total mesorectal excision. Physical activity program in patients with metastatic colorectal cancer who receive palliative firstline chemotherapy. A multicenter open label randomized controlled phase III trial (in CH) 30-Jun-2017 mario.baresic@sakk.ch Sep-2021 catherine.berset@sakk.ch /8

3 Gynaecological INOVATYON 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 Mito/Mango 16b A multicenter 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 (in CH) 30-Jun (in CH) 01-Jan-2017 moritz.jacobshagen@sakk.ch heidi.baumgartner@sakk.ch APL 2006 CML-V Randomized phase III trial assessing the role of arsenic trioxide and/or ATRA during consolidation course in newly diagnosed acute promyelocytic leukemia (APL) Treatment optimization of newly diagnosed Ph/BCR-ABL positive patients with chronic myeloid leukemia (CML) in chronic phase with nilotinib vs. nilotinib plus interferon alpha induction and nilotinib or interferon alpha maintenance therapy (in CH) 15-May-2016 vincent.tchang@sakk.ch (in CH) 30-Sep-2016 moritz.jacobshagen@sakk.ch /8

4 Leukemias EBMT HCT vs CT HOVON TOS Compare conventinal chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation as consolidation therapy. 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 chemotherapy in AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) in patients aged >= 66 years (in CH) 30-Jun-2016 joerg.brechbuehl@sakk.ch (in CH) 15. Aug 16 andrea.fuhrer@sakk.ch HOVON 132 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 years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSS-R risk score > 4.5) (in CH) 30. Apr 17 andrea.fuhrer@sakk.ch /8

5 ETOP 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 (PEARLS) ETOP SPLENDOUR A randomised, open-label phase III trial evaluating the addition of denosumab to standard first-line anticancer treatment in advanced NSCLC (in CH) 30-Jun (in CH) 30-Mar-2018 PEARLS@etop-eu.org SPLENDOUR@etop-eu.org Lung Lung ART EORTC LungArt: Phase III study comparing post-operative conformal radiotherapy to no postoperative radiotherapy in patients with completely resected non-small cell lung cancer and mediastinal N2 Involvement (in CH) 31-Dec-2018 oussama.karroum@eortc.be SAKK 15/12 Early prophylactic cranial irradiation with hippocampal avoidance in patients with limited disease small-cell lung cancer. A multicenter phase II trial Mar-2018 andrea.fuhrer@sakk.ch /8

6 HD 17 Therapieoptimierungsstudie in der Primärtherapie des intermediären Hodgkin Lymphoms: Therapiestratifizierung mittels FDG- PET Dec-2016 IELSG-37 A randomized, open-label, multicentre, two-arm phase III comparative study assessing the role of involved mediastinal radiotherapy after Rituximab containing chemotherapy regimens to patients with newly diagnosed Primary Mediastinal Large B-Cell Lymphoma (PMLBCL) Dec-2016 simona.berardi@sakk.ch 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 Dec-2017 vincent.bize@sakk.ch Lymphomas 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 Mar-2018 katrin.eckhardt@sakk.ch /8

7 SAKK 39/10 Nelfinavir and lenalidomide/dexamethasone in patients with progressive multiple myeloma that have failed lenalidomide-containing therapy. A single arm phase I/II trial Jun-2016 piera.gargiulo@sakk.ch SAKK 39/13 Nelfinavir as Bortezomibsensitizing drug in patients with proteasome inhibitornonresponsive myeloma. A multicenter phase II trial Aug-2016 catherine.berset@sakk.ch T-Cell Project Das T-Cell project ist eine Registrierstudie mit Referenzpathologie um Daten zu seltenen malignen Erkrankungen der T-Zell Linie zu gewinnen. Nachträgliche Erfassung im PATRAS am , Freigabe ca. 2008/ (in CH) 31-Dec-2016 simona.berardi@sakk.ch New Drugs SAKK 66/12 A Phase I, open-label, multicenter, dose escalation study of oral CGM097, a p53/hdm2- interaction inhibitor, in adult patients with se-lected advanced solid tumors characterized by wildtype TP53 6 (in CH) 30-Jun-2016 simona.berardi@sakk.ch SAKK 66/13 INC280 Combination with BKM120 for glioblastoma patients, Phase I/II trial 58 2 (in CH) 30-May-2016 simona.berardi@sakk.ch /8

8 SAKK 01/10 SAKK 06/14 Carboplatin Chemotherapy and Involved Node Radiotherapy in Stage IIA/B Seminoma A phase I/II open label clinical trial assessing safety and efficacy of intravesical instillation of VPM1002BC in patients with recurrent non-muscle invasive bladder cancer after standard BCG therapy Jun Jun-2017 ruth.weiss@sakk.ch milica.enoiu@sakk.ch Urogenital SAKK 63/12 SAKK 96/12 Prospective cohort study with collection of clinical data and serum of patients with prostate disease Prevention of Symptomatic Skeletal Events with Denosumab Administered every 4 Weeks versus every 12 Weeks A Non- Inferiority Phase III Trial Oct (137 Uro) 16-Jan-2019 vincent.bize@sakk.ch andrea.fuhrer@sakk.ch STAMPEDE Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy A multiarm multi-stage randomised controlled trial 58 (in CH) 31-Dec-2016 estelle.cassoly@sakk.ch changed since last issue /8