Übersicht aller Studien: Frau PD Dr. Ruth Seggewiß-Bernhardt (Stand: 17 Mar 2016; 46 Studien)

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1 Screening - anzahl AC Ambit Phase-2 open-label, AC220 monotherapy efficacy (ACE) study in patients with acute myeloid leukemia (AML) with FLT3-ITD activating mutations Mitglied der Akute myeloische II Jun Dec 2012 AIO-TRK-0115 (PRIMUS) A Phase II Randomized, Double- Blind, Placebo-Controlled Study of Pembrolizumab Maintenance Following First-Line Platinum Based Chemotherapy in Patients with Metastatic Squamous - Non- Small Cell Lung Cancer (snsclc) Mitglied der ( ) Bösartige Neubildung der II 02 Mar 2016 AUY922 An open-label, multi-center, Phase- I-IB/II study of AUY922 administered as single agent and in combination with bortezomib with or without dexamethasone in adult patients with relapsed or refractory multiple myeloma Stellvertreter Multiples Myelom I Sep Dec 2011 Belle-2 CKMB120F2302 A phase III randomized, double blind placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment Prüfer ( *) Mammakarzinom III Dec Jun Keine Angabe Seite 1/14

2 Screening - anzahl CBYL719X2101 Head&Neck A phase IA, multicenter, open-label dose escalation study of oral BYL719, in adult patients with advanced solid malignancies, whose tumors have an alteration of the PIK3CA gene Prüfer Kopf-Hals-Malignome Mammakarzinom I/IB Dec May 2014 CBYL719X2103 (Magen- Ca Studie) A phase IB, multicenter, open-label dose escalation study of the PI3K inhibitor BYL719 in combination with the HSP90 inhibitor AUY922 in patients with advanced or metastatic gastric cancer carrying a molecular alteration of PIK3CA or an amplification of HER Prüfer ( *) Mitglied der ( ) Stellvertreter ( ) Magenkarzinom IB Dec Mar 2014 CC 115 ST-001 A PHASE 1A/1B, MULTICENTER, OPEN LABEL, DOSE-FINDING STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF THE DUAL DNA-PK AND TOR KINASE INHIBITOR, CC-115, ADMINISERED ORALLY TO SUBJECTS WITH ADVANCED SOLID TUMORS AND HEMATOLOGIC MALIGNANCIES Mitglied der Multiple I/IB 0 21 May Jan Keine Angabe Seite 2/14

3 Screening - anzahl CEGF816X2201C A phase II, multicenter, parallel group open-label study of EGF816 in combination with Nivolumab in adult patients with EGFR mutated non-small cell lung cancer and INC280 in combination with Nivolumab in adult patients with cmet positive non-small cell lung cancer Prüfer Bösartige Neubildung der II 0 10 Mar 2015 CINC280X2104 A Phase Ib, open-label, multicenter, dose escalation and Expansion study, to evaluate the safety, pharmacokinetics and activity of INC280 in combination with cetuximab in c-met positive CRC and HNSCC patients Prüfer ( *) Kolorektales Karzinom I/IB 24 Jul 2015 CLEE011E2301 (Monaleesa-7) Eine randomisierte, doppelblinde, placebokontrollierte Phase III- Studie mit LEE011 oder Placebo in Kombination mit Tamoxifen und Goserelin oder einem nichtsteroidalen Aromatase Inhibitor (nsai) und Goserelin zur Behandlung von prämenopausalen Frauen mit Hormonrezeptor positivem (HR+), HER2-negativem, fortgeschrittenen Brustkrebs Stellvertreter ( *) Mammakarzinom III 0 13 May Keine Angabe Seite 3/14

4 Screening - anzahl CLL11 / BO21004 An open-label, multi-center, three arm randomized, phase III study to compare the efficacy and safety of RO chlorambucil (GClb), rituximab + chlorambucil (RClb) or chlorambucil (Clb) alone in previously untreated CLL patients with comorbidities Mitglied der Chronische lymphatische III May Jul 2012 CML-Biomarkerstudie Induktion von antileukämischer Immunität: molekulare Mechanismen und klinische Anwendungen Prüfer Chronische myeloische Anwendu ngsbeoba chtung Dec Oct 2013 D1532C00064 ( 64er ) Doppelblinde, randomisierte, plazebokontrollierte Phase-II- Studie zur Untersuchung der Wirksamkeit und Sicherheit von Selumetinib (AZD6244; ARRY ) (Hydrogensulfat) in Kombination mit Docetaxel, verglichen mit Plazebo in Kombination mit Docetaxel bei Patienten, die zur Behandlung eines lokal fortgeschrittenen oder metastasiern, nichtkleinzelligen Bronchialkarzinoms (Stadium IIIb IV) eine Zweitlinientherapie erhalten. (Select 2) Prüfer Bösartige Neubildung der II Mar Oct Keine Angabe Seite 4/14

5 Screening - anzahl D5160C00001 (Aura) A Phase I/II, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Ascending Doses of AZD9291 in Patients with Advanced Non Small Cell Lung Cancer who have Progressed Following Prior Therapy with an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent (AURA) Stellvertreter Bösartige Neubildung der I/II Oct Jan 2015 D5160C00003 AURA3- Studie A Phase III, Open Label, Randomised Study to Assess the Safety and Efficacy of AZD9291 versus Platinum-Based Doublet Chemotherapy in Second-Line Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive (AURA3) Stellvertreter Bösartige Neubildung der III Nov Aug 2015 DSMMV Multizentrische Therapiestudie der MM Studiengruppe Mitglied der Multiples Myelom 01 Jan Dec Keine Angabe Seite 5/14

6 Screening - anzahl Emerge A PHASE 2, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY To determine the Efficacy and Safety OF SINGLE-AGENT LENALIDOMIDE (REVLIMID ) IN PATIENTS WITH MANTLE CELL NHL WHO HAVE RELAPSED or progressed AFTER TREATMENT WITH BORTEZOMIB OR ARE REFRACTORY TO BORTEZOMIB Prüfer Lymphom II Jun Mar 2012 EnestPath CAMN107AIC05 => Medizinische Klinik II, Schwerpunkt Hämatologie/Onkologie ( Med. II, Universitätsklinikum Würzburg ) A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML (ENESTPath) Mitglied der ( *) Chronische myeloische III Feb Apr 2015 Euro-SKI The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine Kinase Inhibitor (TKI). Main goal is the assessment of the duration of major molecular response (MMR) or better after stopping TKI therapy Mitglied der Chronische myeloische Aug Nov Keine Angabe Seite 6/14

7 Screening - anzahl FLIPPER Einarmige, multizentrische Studie zur Bewertung von Pazopanib als Erstlinientherapie in Hochrisikopatienten mit fortgeschrittenem oder metastasierm Nierenzellkarzinom (First Line Pazopanib in Poor Risk Patients with Metastatic Renal Cell Carcinoma) Mitglied der ( *) Nierenzellkarzinom IV 0 08 May 2013 Gaudi An open-label, multicenter, randomized phase Ib study to investigate the saftey and efficacy of RO given in comination with CHOP, FC or bendamustin chemotherapy in patients with CD20+ B-cell follicular lymphoma Mitglied der Lymphom I Jan Dec 2012 KESTREL Stellvertreter Kopf-Hals-Malignome III 6 04 Feb 2016 A Phase III Randomized, Openlabel, Multi-center, Global Study of MEDI4736 in Combination with Tremelimumab versus Standard of Care (EXTREME) in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients - Keine Angabe Seite 7/14

8 Screening - anzahl LBH 589 B 2207 A phase Ib, multi-center, openlabel, dose-escalation study of oral LBH589 and IV bortezomib in adult patients with multiple myeloma CLBH589B Mitglied der Multiples Myelom IB Jul Dec 2011 LUMINIST LUMINIST: LUng cancer Molecular Insights Non Interventional STudy (Nichtinterventionelle Studie zu molekularen Erkenntnissen beim Lungenkarzinom) Stellvertreter Bösartige Neubildung der Jun 2015 MAIN (BO20603) A Study of Avastin (Bevacizumab) in Combination With MabThera (Rituximab) and CHOP Chemotherapy in Patients With Diffuse Large B-Cell Lymphoma. Mitglied der Lymphom III Morphosys A Phase I/IIa, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of the Human Anti-CD38 Antibody MOR03087 as Monotherapy and in Combination with Standard Therapy in Subjects with Relapsed or Refractory Multiple Myeloma Mitglied der Multiples Myelom I/II Jul Keine Angabe Seite 8/14

9 Screening - anzahl MT A Single-Arm Multicenter Phase II Study preceded by Dose Evaluation to Investigate the Efficacy, Safety, and Tolerability of the BITE Antibody Blinatumomab (MT103) in Pediatric and adolescent Patient with Relapsed/Refractory B- Precursor Acute Lymphoblastic Leukemia (ALL) Mitglied der Akute lymphatische II May May 2014 MT An open-label, multi-center dose escalation phase I study to investigate the safety and tolerability of a continuous infusion of the bis pecific T-cell engager (BiTE) MT110, in patients with locally advanced, recurrent, or metastatic solid tumors which commonly express EpCAM and are not amenable to curative treatment Stellvertreter Bösartige Neubildung der Kolorektales Karzinom Magenkarzinom Prostatakarzinom I Nov Jun 2013 Mystic (D419AC00001) A Phase III Randomized, Open- Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small- Cell Lung Cancer (NSCLC) Prüfer Bösartige Neubildung der III Oct Keine Angabe Seite 9/14

10 Screening - anzahl Novartis Logic 2 The LOGIC 2 trial (Protocol CLGX818X2109) A phase II, multi-center, open-label study of sequential LGX818/MEK162 combination followed by a rational combination with targeted agents after progression, to overcome resistance in adult patients with locally advanced or metastatic BRAF V600 melanoma Mitglied der Malignes Melanom II Oct 2014 Palifermin Amgen: Palifermin : Mukositis Mitglied der Weitere 01 May Dec 2008 POMA AMGEN/EBMT: "Prospective Oral Mukositis Audit" Mitglied der Weitere 01 Sep Jan 2006 Prospect A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer Stellvertreter Prostatakarzinom III May Jan Keine Angabe Seite 10/14

11 Screening - anzahl PSMA-BiTE An open-label, Phase I, doseescalation study to characterize the safety, tolerability, pharmacokinetics, and maximum tolerated dose of BAY given once daily by subcutaneous administration or by continuous intravenous infusion in subjects with castration-resistant prostate cancer (CRPC) Stellvertreter Prostatakarzinom I Nov 2012 RATIFY-Studie A Phase III randomized, doubleblind study of induction (Daunorubicin/Cytarabine) and consolidation (high-dose Cytarabine) chemotherapy + Midostaurin (PKC412) (Ind # ) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated acute myeloid leukemia (AML) Mitglied der Akute myeloische III Jan Sep 2011 SELECT-1 (79er - Studie) A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY ) (Hyd-Sulfate) in Combination With Docetaxel, in Patients Receiving Second Line Treatment for KRAS Mutation- Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT 1) Mitglied der Bösartige Neubildung der III Feb Dec Keine Angabe Seite 11/14

12 Screening - anzahl Simplicity STUDYING INTERVENTIONS FOR MANAGING PATIENTS WITH CHRONIC MYELOID LEUKEMIA IN CHRONIC PHASE: THE 5-YEAR PROSPECTIVE COHORT STUDY (SIMPLICITY) Studiennummer: CA Prüfer Chronische myeloische Jul Jul 2015 SNOXA12C301 A multi-center, open label, uncontrolled, Phase IIA clinical trialevaluating the safety and efficacy of NOX-A12 in combination with abackground therapy of bortezomib and dexamethasone (VD) inpreviously treated patients with multiple myeloma (MM) Mitglied der Multiples Myelom II 0 17 Jul Feb 2013 SOLAR An Open-label, Randomized Phase 3 Efficacy Study of ASP8273 vs Erlotinib or Gefitinib in First-line Treatment of Patients with Stage IIIB/IV Non-small Cell Lung Cancer Tumors with EGFR Activating Mutations Mitglied der Bösartige Neubildung der III 0 - Keine Angabe Seite 12/14

13 Screening - anzahl SOLAR-1 A Phase III Randomized Doubleblind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment Stellvertreter Mammakarzinom III 2 01 Oct 2015 SWITCH 2 Study Phase III randomized sequential open-label study to evaluate the efficacy and safety of sorafenib followed by pazopanib versus pazopanib followed by sorafenib in the treatment of advanced / metastatic renal cell carcinoma Mitglied der ( *) Nierenzellkarzinom III Jan 2013 TARGET CAMN107A Nicht-interventionelle Studie zur Sicherheit und Wirksamkeit von Tasigna (NILOTINIB) sowie zur Therapietreue der Patienten in der Behandlung der Philadelphia- Chromosom-positiven chronischen myeloischen in chronischer Phase bei Patienten mit Resistenz oder Unverträglichkeit gegenüber einer vorherigen Behandlung inklusive Glivec ( TARGET ) Mitglied der ( *) Chronische myeloische Feb 2013 THERAKOS Therakos: UVADEX randomized, multicenter, extracorporal, photoimmune Mitglied der Weitere 01 Jan Dec Keine Angabe Seite 13/14

14 Powered by TCPDF ( Übersicht aller Studien: Frau PD Dr. Ruth Seggewiß-Bernhardt (Stand: 17 Mar 2016; 46 Studien) Screening - anzahl TIGER / CML V => Medizinische Klinik II, Schwerpunkt Hämatologie/Onkologie ( Med. II, Universitätsklinikum Würzburg ) Behandlungsoptimierung bei neu diagnostizierten Ph- und/oder BCR- ABL-positiven Patienten mit chronischer myeloischer (CML) in chronischer Phase mit Nilotinib- vs. Nilotinib plus Interferon alpha-induktion und Nilotinib- oder Interferon alpha- Erhaltungsphase. TIGER-Studie Mitglied der Chronische myeloische III Mar 2013 TOPAS Open label, dose escalation study of 4SC-202 in patients with advanced hematologic malignancies: First-In-Man study of a newly developed, oral histone deacetylase inhibitor Mitglied der Akute lymphatische Akute myeloische Chronische lymphatische I Jan Mar 2014 Chronische myeloische... TUD-SORAML-034 A double-blind, placebo-controlled, randomized, multicenter phase IItrial to assess the efficacy of Sorafenib added to standard primary therapy in patients with newly diagnosed AML < 60y of age Mitglied der Akute myeloische II Jun Oct Keine Angabe Seite 14/14