Studienchronologie

Abgeschlossene Studien des Studienzentrum UnterEms:

  • Studie zur Untersuchung von FOLFOXIRI plus Cetuximab oder
    FOLFOXIRI plus Bevacizumab als   Erstlinientherapie des BRAF mutierten,
    metastasierten kolorektalen Karzinoms (FIRE-4.5), Phase II, EudraCT Nr. 2015-004849-11
  • A Phase III, Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB8 (proposed bevacizumab biosimilar) and Avastin® in Subjects with Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer, Phase III, EudraCT Nr. 2015-004026-34
  • Treatment optimization for patients with chronic myeloid leukemia (CML) with treatment naïve disease (1st line) and patients with resistance or intolerance against alternative Abl-Kinase Inhibitors (≥2nd line), Phase II, EudraCT Nr. 2015-003502-16
  • Eine prospektive, zweiarmige, randomisierte multizentrische Phase II Studie einer kombinierten modularisierten Therapie mit metronomem nieder-dosiertem Treosulfan, Pioglitazon und Clarithromycin versus Docetaxel plus Nintedanib bei Patienten mit Nicht-Plattenepithel Karzinom der Lunge und Nivolumab bei Patienten mit Plattenepithelkarzinom der Lunge nach Platinversagen (ModuLung), Phase II, EudraCT Nr. 2014-004095-31
  • A Phase 3 randomized, double-blind Study of PF-06439535 plus Paclutaxel-Carboplatin and Bevacizumab plus Paclitaxel-Carboplatin fort he first-line Treatment of Patients with advanced non-squamous non-small cell Lung Cancer, Phase III, EudraCT Nr. 2014-003878-16
  • Eine multizentrische, randomisierte Phase III-Studie zum Vergleich einer Chemo- versus einer endokrinen Behandlung in Kombination mit einer dualen HER2-gerichteten Herceptin® (Trastuzumab)/ Perjeta® (Pertuzumab)-Therapie plus Kisqali®(Ribociclib) bei Patientinnen mit HER2-positivem und hormonrezeptorpositivem metastasiertem Brustkrebs, Phase IIIa, EudraCT Nr. 2014-002249-22
  • Eine prospektive, offene, multizentrische, randomisierte Phase-III-Studie zum Vergleich der Wirksamkeit und Sicherheit einer kombinierten Therapie von Obinutuzumab und GDC-0199 (ABT-199) versus Obinutuzumab und Chlorambucil bei zuvor unbehandelten Patienten mit CLL und Begleiterkrankungen, Phase III, EudraCT Nr. 2014-001810-24
  • IMPALA-Trial: Evaluation of an immunomodulatory maintenance treatment in patients with metastatic colorectal cancer with tumor reduction during induction treatment – A phase III trial, Phase III, EudraCT Nr. 2014-000834-50
  • Molecularly Stratified Parallel Cohort, Single Arm Phase II Trial of the Phosphoinositide 3-kinase (PI3K) Inhibitor Buparlisib (BKM120) in Combination With Tamoxifen in Patients With Hormone Receptor-positive, HER2-negative Inoperable (Locally Advanced or Metastatic) Breast Cancer With Prior Exposure to Antihormonal Therapy, Phase II, EudraCT Nr. 2014-000599-24
  • A Study of IPI-145 and Ofatumumab in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Previously Enrolled in Study IPI-145-07, Phase III, EudraCT Nr. 2013-003639-31
  • Randomized Clinical Trial of Maintenance Therapy with Immunomodulator MGN1703 in Patients with Extensive Disease Small Cell Lung Cancer after Platinum-Based First-Line Therapy, Phase II, EudraCT Nr. 2013-003503-19
  • Multizentrische, randomisierte, Open-Label, 2-Arm Phase III-Studie zur Therapie mit BMN 673 (Talazoparib) vs. Standardtherapie bei Patientinnen mit BRCA-Mutation und lokal fortgeschrittenem oder metastasiertem Mammakarzinom, die zuvor maximal 3 Therapien in der metastasierten Situation erhalten haben, Phase III, EudraCT Nr. 2013-002716-28
  • A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of IPI-145 in Combination with Rituximab vs Rituximab in Subjects with Previously-Treated Follicular Lymphoma, Phase III, EudraCT Nr. 2013-002406-31
  • A Phase 3 Study of IPI-145 versus Ofatumumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Phase III, EudraCT Nr. 2013-002405-61
  • Phase IIIb Studie zu Lipegfilgrastim im Vergleich zu Pegfilgrastim bei Non-Hodgkin Lymphoma, Phase III, EudraCT 2013-001284-23
  • A multicenter phase II study in patients with HER2-negative metastatic breast cancer and persisting HER2-negative circulating tumor cells (CTCs), Phase II, EudraCT Nr. 2013-001269-18
  • A Multinational, Phase 3, Randomized, Double Blind, Placebo Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration Resistant Prostate Cancer, Phase III, EudraCT Nr. 2012-005665-12
  • A randomized, open-label, multi-centre Study to evaluate Patient preference with subcutaneous administration of Rituximab versus intravenous Rituximab in previously untreated Patients with CD20+ diffuse large B-Cell LLymphoma or CD20+ follicular non-Hodgin Lymphoma Grades 1, 2 or 3A, Phase III, EudraCT Nr. 2012-003230-17
  • A phase III randomized, double blind, placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative AI treated, locally advanced or metastatic breast cancer, Phase III, EudraCT Nr. 2012-002571-34
  • Phase II Trial of CAP7.1 in adult patients with refractory malignancies Small cell lung carcinoma, Non-small cell lung carcinoma Biliary carcinoma, Phase II, EudraCT Nr. 2012-002378-30
  • Multizentrische, Phase II Studie mit Cabazitaxel bei vorbehandelten Patienten mit fortgeschrittenem oder metastasiertem Adenokarzinom des ösophagogastralen Übergangs und des Magens, Phase II, EudraCT Nr. 2012-001271-37
  • Eine neo-/ adjuvante Phase III Studie zum Vergleich einer intensivierten dosis¬dichten Therapie mit einer adaptierten dosisdichten Therapie bei Patientinnen mit einem frühen Hochrisiko-Brustkrebs, Phase III, EudraCT Nr. 2011-005214-11
  • 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 cancer, Phase III, EudraCT Nr. 2011-004396-36
  • A Two-cohort, Open-label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in First Line Patients With HER2-positive Advanced (Metastatic or Locally Advanced) Breast Cancer, Phase II, EudraCT Nr. 2011-003308-18
  • Vinorelbine In Combination with the mTOR Inhibitor Everolimus vs Vinorelbine monotherapy in Advanced breast cancer, Phase II, EudraCT Nr. 2011-001024-38
  • An open-label, multicenter, expanded access study of INC424 for patients with primary myelofibrosis (PMF) of post polycythemia vera myelofibrosis (PPV MF) or post-essential thrombocythemia myelofibrosis, Phase II, EudraCT Nr. 2010-024473-39
  • DETECT III – A multicenter, randomized, phase III study to compare standard therapy alone versus standard therapy plus Lapatinib in patients with initially HER2-negative metastatic breast cancer and HER2-positive Circulating Tumor Cells, Phase III, EudraCT Nr. 2010-024238-46
  • An Open-Label, Randomized, Parallel Group Study of Patients Treated with Paclitaxel with Standard Dosing versus Pharmacokinetic Guided Dose Adjustment in Patients with Advanced NSCLC, Phase III, EudraCT Nr. 2010-023688-16
  • Randomized, Placebo-controlled, Double-blind Phase 1b/2 Study of U3-1287 (AMG 888) in Combination with Erlotinib in EGFR Treatment Naive Subjects with Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on at Least One Prior Chemotherapy, Phase II, EudraCT Nr. 2010-021082-74
  • An open-label, randomized phase III trial of cisplatin and 5-fluorouracil with or without panitumumab for patients with nonresectable, advanced or metastatic esophageal squamous cell cancer, Phase III, EudraCT Nr. 2010-020606-15
  • A Phase III trial to compare the safety and efficacy of lapatinib plus trastuzumab plus an aromatase inhibitor (AI) versus trastuzumab plus an AI versus lapatinib plus an AI as first- or second-line therapy in postmenopausal subjects with hormone receptor positive, HER2-positive metastatic breast cancer (MBC) who have received prior trastuzumab and endocrine therapies, Phase III, EudraCT Nr. 2010-019577-16
  • Eine randomisierte Phase II-Studie zu einer Standardkombination mit einer Carboplatin-basierten Chemotherapie mit oder ohne Panitumumab in der Therapie von Patientinnen mit Platin-sensitivem, rezidiviertem Ovarialkarzinom, Phase II, EudraCT Nr. 2010-018849-59
  • Eine randomisierte, doppelblinde, multizentrische Phase III Studie zum Vergleich von Paclitaxel mit und ohne RAD001 bei Pat. mit Magenkarzinom nach Versagen einer Therapie mit einem fluoropyrimidinhaltigen Schema, Phase III, EudraCT Nr. 2009-018092-14
  • Randomised phase II study of paclitaxel alone versus paclitaxel plus sorafenib in second- or third-line treatment of patients with metastatic breast cancer, Phase II, EudraCT Nr. 2009-018025-73
  • Adjunction with Capecitabin, Lapatinib and Vinorelbin to treat patients with HER2/new-positive, advanced or metastized breast cancer after failure of Trastuzumab, Phase II, EudraCT Nr. 2009-017219-13
  • A randomized, Placebo-controlled, Phase 1/2 Study of ARQ 197 in combination with Irinotecan and Cetuximab in subjects with metastatic colorectal Cancer with wild-type KRAS who have received front-line systemic Therapy, Phase II, EudraCT Nr. 2009-016025-34
  • Sequential first-line therapy in metastatic colorectal cancer with Capecitabine/FUFA, Irinotecan and Bevacizumab
    – Capecitabine/FUFA plus Bevacizumab versus Capecitabine/FUFA plus Irinotecan plus Bevacizumab as first-line therapy in metastatic colorectal cancer, Phase III, EudraCT Nr. 2009-013099-38
  • Eine offene, multizentrische, dreiarmig randomisierte
    Phase-III-Studie zum Vergleich der Wirksamkeit und Sicherheit von RO5072759 + Chlorambucil (GClb), Rituximab + Chlorambucil (RClb) oder Chlorambucil alleine (Clb) bei zuvor unbehandelten CLL-Patienten mit Komorbiditäten, Phase III, EudraCT Nr. 2009-012476-28
  • Randomized three arm phase III trial on induction treatment with a fluoropyrimidine-, oxaliplatin- and bevacizumab-based chemotherapy for 24 weeks followed by maintenance treatment with a fluoropyrimidine and bevacizumab vs. bevacizumab alone vs. no maintenance treatment and reinduction in case of progression for first-line treatment of patients with metastatic colorectal cancer, Phase III, EudraCT Nr. 2008-007974-39
  • Simultaneous Study of Docetaxel Based Anthracycline Free Adjuvant Treatment Evaluation, as well as Life Style Intervention Strategies SUCCESS C-Trial, Phase III, EudraCT Nr. 2008-005453-38
  • A phase III randomized sequential open-label study to evaluate the efficacy and safety of sorafenib followed by sunitinib versus sunitinib followed by sorafenib in the treatment of first-line advanced / metastatic renal cell carcinoma, Phase III, EudraCT Nr. 2008-005011-18
  • A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have not Progressed after First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, Phase III, EudraCT Nr. 2008-004672-50
  • Capecitabine and bevacizumab ± vinorelbine as 1st line treatment in HER2/neu-negative metastatic or locally advanced inoperable breast cancer patients, Phase III, EudraCT Nr. 2008-003779-37
  • Randomized Phase III Study on Bortezomib and Low-Dose Dexamethasone with or without Continuous Low-Dose Oral Cyclophosphamide for Primary Refractory or Relapsed Multiple Myeloma, Phase III, EudraCT Nr. 2008-003213-27
  • A multinational, randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of AVE5026 in the prevention of venous thromboembolism (VTE) in cancer patients at high risk for VTE and who are undergoing chemotherapy, Phase II, EudraCT Nr. 2007-007943-29
  • Phase-III-Studie einer kombinierten Immunchemotherapie von Fludarabin, Cyclophosphamid und Rituximab (FCR) versus Bendamustin und Rituximab (BR) bei unbehandelten Patienten mit Chronisch Lymphatischer Leukämie, Phase III, EudraCT Nr. 2007-007587-21
  • A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients with HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chemotherapy Plus Trastuzumab Plus Bevacizumab, Phase III, EudraCT Nr. 2007-005182-35
  • A Randomised, Open-Label, Phase III Study of Taxane Based Chemotherapy with Lapatinib or Trastuzumab as First-Line Therapy for Women With HER2/neu Positive Metastatic Breast Cancer, Phase III, EudraCT Nr. 2007-004568-27
  • CONKO-005: Adjuvante Therapie des R0-resezierten Pankreaskarzinoms mit Gemcitabin plus Erlotinib versus Gemcitabin über 24 Wochen – eine prospektive, randomisierte, Phase III Studie, EudraCT Nr. 2007-003813-15
  • Sunitinib in Refractory Adrenocortical-Carcinoma patients progressing after cytotoxic chemotherapy (SIRAC), EudraCT Nr. 2007-001165-15
  • Simultaneous Study of Gemcitabine-Docetaxel Combination adjuvant treatment, as well as Biological Targeted Treatment SUCCESS B-Trial, Phase III, EudraCT Nr. 2007-001094-29
  • CONKO-006 Additive Therapie beim R1-resezierten Pankreaskarzinom mit Gemcitabin plus Sorafenib versus Gemcitabin plus Placebo über 12 Monate – eine doppelblinde, placebokontrollierte Phase IIb Studie, EudraCT Nr. 2007-000718-35
  • A phase III multi-center, open label, randomized study of imatinib versus nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP), Phase III, EudraCT Nr. 2007-000208-34
  • Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer (PETACC-6), Phase III, EudraCT Nr. 2006-006532-21
  • Inoperable Non-Squamous NSCLC Stage III/IV: A Randomised Phase II Study with Bevacizumab plus Erlotinib Or Gemcitabin/Cisplatin plus Bevacizumab, Phase II, EudraCT Nr. 2006-004865-32
  • A randomized, open-label phase III Intergroup study: Effect of adding Bevacizumab to cross over fluoropyrimidine based chemotherapy (CTx) in patients with metastatic colorectal cancer and disease progression under first-line standard CTx / Bevacizumab combination, Phase III, EudraCT Nr. 2006-004634-32
  • Randomisierte Studie zur Wirksamkeit von FOLFIRI in Kombination mit Cetuximab vs. Bevacizumab in der Erstlinien-Behandlung des metastasierten kolorektalen Karzinoms, Phase III, EudraCT Nr. 2006-004030-32
  • A one-year, open-label, single arm, multi-center trial evaluating the efficacy and safety of oral ICL670 in patients diagnosed with Low and INT-1 risk Myelodysplastic Syndrome (MDS) and transfusion-dependent iron overload, Phase II, EudraCT Nr. 2006-003971-11
  • Effektivitätsoptimierte und toxizitätsreduzierte Therapie des metastasierten Kolorektalkarzinoms in der First-line Therapie, Phase III, EudraCT Nr. 2006-002744-28
  • A Phase 2, Multicentre, Randomised, Open-Label, Parallel Group Study to Evaluate the Safety and Efficacy of Velcade® when added to Adriamycin-Dexamethasone Treatment versus Vincristine-Adriamycin-Dexamethasone Standard Treatment in Subjects with Multiple Myeloma who are Refractory to or Have Relapsed after Primary Therapy for Multiple Myeloma, Phase II, EudraCT Nr. 2006-001709-27
  • ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) study. A randomised, multi-centre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cance, Phase III, EudraCT Nr. 2006-000562-36
  • Open-label study of bevacizumab (AVASTIN®) in combination with platinum-containing chemotherapy as first-line treatment of patients with advanced or recurrent non-squamous non-small cell lung cancer, Phase III, EudraCT Nr. 2005-005887-97
  • Prospectively Randomized Phase I/II Trial of Liposomal-encapsulated Doxorubicin and Cisplatin +/- Locoregional Hyperthermia in patients with Metastatic Breast Cancer, Phase II, EudraCT Nr. 2005-005862-36
  • A randomized discontinuation phase II study to determine the efficacy of RAD001 in breast cancer patients with bone metastases, Phase II, EudraCT Nr. 2005-005835-87
  • OPERA: OXALIPLATIN AND CETUXIMAB IN FIRST-LINE TREATMENT OF mCRC – Open, non-controlled, multicenter phase II study evaluating 5-FU/FA plus oxaliplatin (FOLFOX-4) plus cetuximab as first-line treatment for patients with undetectable EGFR-status in metastatic colorectal cancer, Phase II, EudraCT Nr. 2005-005154-44
  • Bortezomib as consolidation therapy in patients aged 60 years and younger with multiple myeloma, EudraCT Nr. 2005-004948-31
  • Bortezomib as consolidation therapy in patients aged 61-75 years with multiple myeloma, EudraCT Nr. 2005-004947-73
  • A randomized, multicentre, open-label Phase III study of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with metastatic breast cancer whose disease has progressed on trastuzumab-containing regimens, Phase III, EudraCT Nr. 2005-003926-24
  • Adjuvant Treatment of fully resected Stage III Colon Cancer with FOLFOX-4 vs. FOLFOX-4 plus Cetuximab, Phase III, EudraCT Nr. 2005-003463-23
  • A multinational, Subsidiary Sponsored, Randomized, Open-Label Study Comparing Treatment with Either Pegylated Liposomal Doxorubicin or Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer, Phase II, EudraCT Nr. 2005-003164-35
  • Randomized phase III trial comparing early treatment with fludarabine, cyclophosphamide + rituximab versus deferred treatment in untreated Binet stage A patients with high risk of progression – CLL 7 protocol of the GCLLSG and FCGCLL, Phase III, EudraCT Nr. 2005-003018-14
  • Effect of intravenous Zoledronic Acid on Bone Metabolism given over 4 month in patients with prostate cancer or breast cancer and bone metastasis. A prospective, single-arm multicenter study” (ZoTect), Phase II, EudraCT Nr. 2005-002132-94
  • Simultaneous Study of Gemcitabine-Docetaxel Combination adjuvant treatment, as well as Extended Bisphosphonate and Surveillance-Trial SUCCESS-Trial, Phase II, EudraCT Nr. 2005-000490-21
  • A multicentre phase I-II study to investigate the combination of bendamustine with weekly paclitaxel as first or second line therapy in patients with metastatic breast cancer, Phase II, EudraCT Nr. 2004-004880-31
  • An open label, multicenter, randomized, phase 3 study of S-1 in combination with cisplatin compared against 5-FU in combination with cisplatin in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease, Phase III, EudraCT Nr. 2004-004710-16
  • An open phase III trial with Letrozole (Femara®) alone or in combination with Zoledronic acid (Zometa®) as extended adjuvant treatment of postmenopausal patients with primary breast cancer, Phase III, EudraCT Nr. 2004-003888-71
  • Continuous fluorouracil plus mitomycin C versus mitomycin C plus Cisplatin as chemotherapy combination in combined radiochemotherapy for locally advanced anal cancer. A phase II-III study, EucdraCT Nr. 2004-000329-31