Trial Trial Name Opening of the first site. Enzalutamide in combination with metformin vs. enzalutamide in patients with CRPC

Transcription

1 TRIALS TO BE ACTIVATED 2016/2017 Trial Trial Name Opening of the first site SAKK 41/13 SAKK 08/14 (IMPROVE) SAKK 16/14 SAKK 21/12 (Phase II part) GRAALL-2014 HD21 HOVON 103 SEL SAKK 30/10 IELSG-42 IELSG-43 SAKK 24/14 Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients. A randomized, doubleblinded, placebo-controlled, phase III trial. Q1-Q Enzalutamide in combination with metformin vs. enzalutamide in patients with CRPC Q progressing on androgen deprivation therapy (ADT). Perioperative anti-pd-l1 antibody MEDI4736 in addition to standard neoadjuvant chemotherapy Q in non-small cell lung cancer (NSCLC) patients with mediastinal lymph node metastases (stage IIIA, N2). 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. Treatment of adult acute lymphoblastic leukemia (ALL), evaluating the addition of a second late intensification course in B-lineage PH-negative ALL, the addition of Nelara-bine in high-risk T-lineage ALL, and the reduction of chemotherapy intensity in Ph+ ALL. Treatment optimization trial in the first-line treatment of advanced stage Hodgkin Lymphoma: comparision of 6 cycles of escaleted BEACOPP with 6 cycles of BrECADD. 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 therapy in AML high risk myelodysplasia (MDS) (IPSS-R risk score >4.5) in patients aged 66 years. An international phase II trial assessing tolerability and efficacy of sequential Methotrexate- Aracytin-based combination and R-ICE combination followed by high-dose chemotherapy supported by autologous stem cell transplant in patients with systemic DLBCL with CNS involvement at diagnosis or relapse (MARIETTA regimen). High-dose chemotherapy and autologous stem cell transplant consolidating conventional chemotherapy in primary CNS lymphoma -randomized phase III trial. A phase II study of anti-egfr-ils loaded with doxorubicin in patients with advanced triple negative breast cancer (TNBC). Q Q / 5

2 SAKK 67/15- CDA CDI-CS- 003 IBCSG/ABCSG PALLAS PRODIGE 32 SAKK 35/15 HOVON 135 MCL young/ TRIANGLE SAKK 41/16 SAKK 11/16 HOVON 127/SAKK 37/16 SAKK 08/15 ProMET An open-label Phase 1/2a study of BAL administered as a continuous intravenous infusion in adult patients with advanced solid tumors. A randomized phase 3 trial of Palbociclib with adjuvant endocrine therapy versus endocrine therapy alone for hormone receptor positive/her2-negative breast cancer. Randomised phase II-III strategic trial in operable oesophageal cancer in case of clinical complete response after chemoradiation: systematic surgery vs surveillance with selective salvage surgery in case of operable recurrence. A phase I study of GA101 in combination with ABT199 in follicular lymphoma patients in 1 st Line. A randomized phase II multicenter study to assess the tolerability and efficacy of the addition of ibrutinib to 10-day decitabine in UNFIT (i.e. HCT-CI 3) AML and high risk myelodysplasia (MDS) (IPSS-R > 4.5) patients aged > 66 years. Efficacy of Ibrutinib during R-CHOP/R-DHAP induction and after or in comparison to autologous stem cell transaplantation (ASCT) in previously untreated patients with mantle cell lymphoma. Impact of neoadjuvant treatment with Regorafenib and Capecitabine combined with radiotherapy in locally advanced rectal cancer. A Phase Ib trial (RECAP). Personalized, cell-based antitumor immunization with MVX-ONCO-1, a combination of subcutaneous irradiated autologous tumor cells and encapsulated allogeneic cells engineered to release GM-CSF: a single arm Phase II trial. Randomized phase III study comparing R-CODOX-M/R-IVAC versus dose-adjusted EPOCH-R (DA-EPOCH-R) for patients with newly diagnosed high risk Burkitt lymphoma. Multicenter, Randomized, Double Blind, Placebo Controlled Phase II Trial of Salvage Radiotherapy +/- Metformin HCL after Prostatectomy Failure. Q3 2016** Q Q3 2016* Q Q * Q * Q Q4 2016/ Q Q * on hold due to financial reasons if financing is secured * Depends also on the foreign study group ** The sponsor of the trial postponed Submission changed since last news issue / 5

3 ACTIVATED TRIALS November 2015 to March 20, 2016 Trial code Protocol title Activation date Coordinating Clinical Project Manager investigator IBCSG 50-14/BIG 6-13 A randomised, double blind, parallel group, Urban Novak Christiane Andrieu placebocontrolled multi centre Phase III study to assess the efficacy and safety of olaparib vs placebo as adjuvant treatment in patients with high risk germline BRCA mutated HER2 negative breast cancer who have completed definitive local and systemic neoadjuvant/adjuvant treatment. SAKK 41/14 Physical activity program in patients with metastatic colorectal cancer who receive palliative first-line chemotherapy. A multicenter open label randomized controlled phase III trial Viviane Hess Catherine Berset AUTHORIZED TRIALS November2015 to March 20, 2016 Trial code Protocol title Approval date competent authority & Ethical Committee SAKK 41/13 Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients. A randomized, double-blinded, placebo-controlled, phase III trial (EC) (SM) Coordinating Investigator: Prof. Dr. Ulrich Güller CPM: Daniela Bärtschi COMMENT: Expected opening: April 2016 HOVON 103 SEL 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 (EC) (SM) Coordinating Investigator: PD Dr. Georg Stüssi CPM: Dr. Andrea Fuhrer COMMENT: Trial not yet approved in the Netherlands / 5

4 APPROVAL BY ETHICAL COMMITTEES November 2015 to March 20, 2016 Trial code Protocol title Approval ethical committee HOVON 103 SEL 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 Coordinating Investigator: PD Dr. Georg Stüssi CPM: Dr. Andrea Fuhrer TRIALS CLOSED FOR ACCRUAL as of March 20, 2016 Trial code Protocol title Trial closure SAKK 16/08 Preoperative chemotherapy and radiotherapy with concomitant Cetuximab in non-small cell lung cancer (NSCLC) patients with IIIB disease. A multicenter phase II trial. Coordinating Investigator: Prof. Dr. med. Solange Peters CPM: Dr. Piera Gargiulo SAKK 22/10 A randomized phase II trial of pertuzumab in combination with trastuzumab with or without chemotherapy, both followed by T-DM1 in case of progression, in patients with HER2-positive metastatic breast cancer. Coordinating Investigator: Dr. med. Patrik Weder CPM: Dr. Marie-Aline Gerard SAKK 33/14 Effects of sympathicomimetic agonists on the disease course and mutant allele burden in patients with JAK2-mutated myeloproliferative neoplasms A multicenter phase II trial. Coordinating Investigator: Prof. Dr. Med. Jakob Passweg CPM: Dr. Andrea Fuhrer SAKK 69/13 Phase IB of oral BGJ398 (pan FGFR inhibitor) and oral BYL719 (a specific PI3K inhibitor) in adult patients with selected solid tumors. Coordinating Investigator: Prof. Dr. Med. Cristiana Sessa CPM: Dr. Simona Berardi / 5

5 TRIALS TERMINATED as of March 20, 2016 Trial News 2016 Trial code Protocol title Trial closure SAKK 43/99 A phase III trial of preoperative vs postoperative chemotherapy with Taxotere- Cisplatin-5FU (TCF) in patients with locally advanced operable gastric carcinoma. Coordinating Investigator: Dr. R. Morant, St. Gallen CPM: Sandra Thierstein SAKK 38/07 Prospective evaluation of the predictive value of PET in patients with diffuse large B-cell-lymphoma under R-CHOP Coordinating Investigator: Prof. Dr. C. Mamot CPM: Dr. Corinne Rusterholz / 5