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1 Updated Feb 18/16. Please note, although every effort is made to keep this list as up-to-date as possible, some trial status updates may not be reflected in the list below. DST Project Title Project Display Title Project site status Clinical trials gov number Breast Cardiac Biomarker (Cabot) Determining the Cardiac Biomarker Profile in Breast Cancer Patients Receiving Adjuvant Trastuzumab Therapy Breast CK Breast Study (ARTEMIS) Feasibility Study of the Role of Stereotactic Body Radiotherapy for the Treatment of Early Stage Breast Cancer Breast IND.213 A Study of Reolysin For Patients With Advanced/Metastatic Breast Cancer Breast MA.32D (Alliance ) CHANGE IN MAMMOGRAPHIC DENSITY WITH METFORMIN USE: A COMPANION STUDY TO NCIC CTG STUDY MA.32 NCT NCT Breast MELO-D Anti-Proliferation Effects of Vitamin D and Melatonin in Breast Cancer Breast OCOG-2011-PETRA Imaging With 111 Indium (111In)-Pertuzumab (PmAb) to Predict Response to Trastuzumab (TmAb) in Human Epidermal Growth Factor-2 (HER2) Positive Metastatic Breast Cancer (MBC) (PETRA) NCT NCT Breast OCOG-2012-LUMINA A Prospective Cohort Study Evaluating Risk of Local Recurrence Following Breast Conserving Surgery and Endocrine Therapy in Low Risk Luminal A Breast Cancer (LUMINA) Breast RTOG 1119 Whole-Brain Radiation Therapy With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer Breast RUBY Breast Study Reducing the burden of breast cancer in young women NCT NCT GI CO.21 A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patients With High Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial (CHALLENGE) NCT

2 GI HE.1 A PHASE III STUDY OF PALLIATIVE RADIOTHERAPY FOR SYMPTOMATIC HEPATOCELLULAR CARCINOMA AND LIVER METASTASES GI MK (KEYNOTE 059) A Phase II Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil in Subjects with Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE- 059) GI NEC.3 Prospective Randomized Phase II Trial of Pazopanib (NSC # , IND 75648) Versus Placebo in Patients With Progressive Carcinoid Tumors GI PA.6 (PRODIGE) Multicentric Randomized Phase III Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus 5- fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mfolfirinox) in Patients With Resected Pancreatic Adenocarcinoma GI RTOG 1112 Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer Suspended Suspended NCT NCT NCT NCT NCT GU\RENAL AGS15E-13-1 A Phase 1 Study of the Safety and Pharmacokinetics of Escalating Doses of AGS15E Given as Monotherapy in Subjects with Metastatic Urothelial Cancer GU\RENAL BL.12 Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients With Advance Urothelial Cancer Progressing on or After Platinum Containing Regimen. NCT NCT GU\RENAL D419BC00001 (DANUBE) A Phase III, Randomized, -label, Controlled, Multi- Center, Global Study of First-Line MEDI4736 Monotherapy and MEDI4736 in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Unresectable Stage IV Urothelial Bladder Cancer NCT

3 GU\RENAL IMRT_ISD_JARES Randomized Study of Quality of Life in Patients with High- Risk Prostate Cancer Undergoing Radiotherapy: Role of Pelvic Nodal IMRT GU\RENAL LPS14022 Phase II, randomized, open label, multicenter study in chemotherapy-naïve metastatic Castration-Resistant Prostate Cancer (mcrpc) patients who have PRIMary resistance toabiraterone acetate or Enzalutamide treatment comparing the anti-tumor effect of CABazitaxel to alternative Androgen Receptors (AR) targeted therapy NCT GU\RENAL GU\RENAL NCRN / SPARTAN - ARN-509 in non-metastatic castration-resistant prostate ca NCRN BAYER Radium223 in subjects with bone predominant metastatic CRPC SPARTAN - A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer A phase III randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve subjects with bone predominant metastatic castration-resistant prostate cancer (CRPC) GU\RENAL OZM-053 A Phase II, Multi-Centre Study, of Stereotactic Radiotherapy for Oligo-Progression in Renal Cell Cancer Patients Receiving 1st Line Sunitinib Therapy GU\RENAL OZM-054 A Phase II, randomized, multi-center study of cabazitaxel versus abiraterone or enzalutamide in poor prognosismetastatic castration-resistant prostate cancer NCT NCT GU\RENAL PR.17 (ANZUP 1304) RANDOMIZED PHASE 3 TRIAL OF ENZALUTAMIDE IN FIRST LINE ANDROGEN DEPRIVATION THERAPY FOR METASTATIC PROSTATE CANCER: ENZAMET NCT

4 GU\RENAL RTOG 0815 Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer NCT GU\RENAL TOPCOP TOward Personalizing Care for Older men with mcrpc - understanding and predicting treatment toxicities (the TOPCOP study) GU\RENAL WO MPDL3280A in renal cell A phase III, open-label, randomized study of MPDL3280A (Anti-PD-L1 antibody) in combination with bevacizumab versus sunitinib in patients with untreated advanced renal cell carcinoma GYNE ARRAY :The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) A Multinational, Randomized, -label Phase 3 Study of MEK162 vs. Physician s Choice Chemotherapy in Patients with Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum NCT NCT NCT GYNE CO (ARIEL3) A Multicenter, Randomized, Double-Blind, Placebo- Controlled Phase 3 Study of Rucaparib as witch Maintenance Therapy Following Platinum-Based Chemotherapy in Patients with Platinum-Sensitive, Relapsed High-Grade Serous Ovarian Cancer (ARIEL3) NCT GYNE IND.221 A DOSE-RANGING STUDY OF IPH2201 IN PATIENTS WITH Suspended NCT HIGH GRADE SEROUS CARCINOMA OF GYNE PHL-086 A Study of XL184 (Cabozantinib) in Endometrial Cancer NCT GYNE RTOG 1174 (OUTBACK) A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial Head&Neck D419LC00001 (KESTREL) A Phase III Randomized, -label, Multi-center, Global Study of MEDI4736 in Combination with Tremelimumab versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients NCT NCT

5 Head&Neck MU ALTENS for Dysphagia: A Pilot Study of ALTENS in Improving Dysphagia Induced by IMRT for Head and Neck Cancers Effectiveness of Acupuncture-like Transcutaneous Nerve Stimulation (ALTENS) in Improving Dysphagla and Associated Symptoms of Current Chemotherapy and IMRT for Head and Neck Cancers: A Pilot Study NCT Head&Neck NRG HN002 A RANDOMIZED PHASE II TRIAL FOR PATIENTS WITH p16 POSITIVE, NON-SMOKING ASSOCIATED, LOCOREGIONALLY ADVANCED OROPHARYNGEAL CANCER NCT Head&Neck PHL-088:Cisplatin With or Without MK in Squamous Cell Cancer of the Head and Neck A Randomized Phase II Trial of Cisplatin with or without Wee1 kinase inhibitor MK-1775 for First-line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (RM-SCCHN) NCT Hematology AV001 (BFORE) A Multicenter Phase 3 Randomized, -Label Study of Bosutinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia NCT Hematology CICL670A2421:Combination Study of Deferasirox and Erythropoietin in Patients With Low- and Int-1-risk Myelodysplastic Syndrome. An open-label, phase II, randomized, pilot study to assess the effect in term of erythroid improvement of deferasirox combined with erythropoietin compared to erythropoietin alone in patients with low- and int-1-risk myelodysplastic syndrome. Hematology CINC424B2001X An open-label, multi-center, Expanded Treatment Protocol (ETP) of ruxolitinib in patients with Polycythemia Vera who are Hydroxyurea resistant or intolerant and for whom no treatment alternatives are available. NCT NCT Hematology CLC.2 (ALLIANCE A041202) A RANDOMIZED PHASE III STUDY OF BENDAMUSTINE PLUS RITUXIMAB VERSUS IBRUTINIB PLUS RITUXIMAB VERSUS IBRUTINIB ALONE IN UNTREATED OLDER PATIENTS (> 65 YEARS OF AGE) NCT

6 Hematology GS-US A Phase 3, Randomized Study To Evaluate the Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects with Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis who were Treated with Ruxolitinib NCT Hematology KCP (STOMP) A Phase 1b/2 Study of Selinexor (KPT-330) in Combination with Backbone Treatments for Resistant/Refractory Multiple Myeloma Hematology MEDICATE - Cardiac Troponin Study MEDICATE - Cardiac Troponin Study NCT Hematology Hematology NCRN / GS-US : Momelotinib vs. Ruxolitinib in PMF or Post-PV/ET MF NCRN525 (AZACITIDINE + BSC v PLACEBO + BSC) A Phase 3, Randomized, Double-blind Active-controlled Study Evaluating Momelotinib vs. Ruxolitinib in Subjects with Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post- Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF) A phase 3, multicentre, randomized, double-blind study to compare with efficacy and safety of oral azacitidine plus best supportive care versus placebo plus best supportive care in subjects with red blood cell transfusion-dependent anemia and thrombocytopenia due to IPSS lower-risk myelodysplatic syndromes NCT NCT Hematology OZM-056 / TRAD-CML (BMS CA ) Treatment-free Remission Accomplished with Dasatinib in Patients with CML Lung BR.31 A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer. NCT NCT

7 Lung CA (CheckMate 169) Expanded Access Program with Nivolumab Monotherapy in Subjects with Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer Who Have Received at Least One Prior Systemic Regimens for the Treatment of Stage IIIb/IV SqNSCLC Lung CFZ004 Phase 1b/2, Multicenter, -label Study of Carfilzomib, Carboplatin, and Etoposide in Subjects with Previously Untreated Extensive-stage Small-cell Lung Cancer Lung CLDK378A2112 A multi-center, randomized open label study to assess the systemic exposure, efficacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC) Lung D5160C00007 (FLAURA-1) A Phase III, Double-Blind, Randomised Study to Assess the Efficacy and Safety of AZD9291 versus a Standard of Care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First-Line Treatment in Patients with Epidermal Growth Factor Receptor Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Lung IND.219 A RANDOMIZED PHASE II TRIAL OF SELUMETINIB IN PATIENTS RECEIVING STANDARD PEMETREXED AND CISPLATIN CHEMOTHERAPY FOR THE TREATMENT OF ADVANCED OR METASTATIC KRAS WILDTYPE OR UNKNOWN NON-SQUAMOUS NON-SMALL CELL LUNG CANCER Lung NCRN VESTA: Veliparib, carboplatin & paclitaxel in NSCLC NSCLC M11089 A Phase 3 Veliparib plus Chemotherapy Study in Adv/Met squamous NSCLC NCT NCT NCT NCT NCT

8 Lung OCOG-2011-BRACHY A Trial to Evaluate the Improvement in Lung Cancer Patients Receiving Radiation With or Without Brachytherapy (BRACHY) Lung OCOG-2013-LUSTRE A Randomized Trial of Medically-Inoperable Stage I Non- Small Cell Lung Cancer Patients Comparing Stereotactic Body Radiotherapy Versus Conventional Radiotherapy (LUSTRE) Lung OCOG-2014-ALMERA A Phase II Study to Investigate a Combination of Metformin with Chemo-Radiotherapy in Patients with Locally Advanced Non-Small Cell Lung Cancer Advanced Lung Cancer Lung TIDAL Study of a Tiotropium Inhaler For Shortness of Breath in Advanced Non-Small Cell Lung Cancer (TIDAL) NCT NCT NCT NCT Melanoma BRF BRF117277: A Phase II, -Label, Multicentre Study of Dabrafenib plus Trametinib in Subjects with BRAF Mutation-Positive Melanoma that has Metastasized to the Brain Melanoma CA Expanded Access Program with Nivolumab for Subjects with Histologically Confirmed Stage III Melanoma CA (CheckMate 218) Expanded Access Program with Nivolumab (BMS ) in Combination with Ipilimumab (Yervoy) in Subjects with Unresectable or Metastatic Melanoma NCT NCT NCT Melanoma OZM-049/TH-CR-413 A Phase 2 Biomarker-Enriched Study of TH-302 in Subjects with Advanced Melanoma Neuro SABR-COMET Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastatic Tumors (SABR-COMET): A Randomized Phase II Trial Other MITNEC-A1 18F- Sodium Fluoride PET Imaging as a Replacement for Bone Scintigraphy NCT NCT NCT

9 Other SC.24 A PHASE II RANDOMIZED FEASIBILITY STUDY COMPARING STEREOTACTIC BODY RADIOTHERAPY (SBRT) VERSUS CONVENTIONAL PALLIATIVE RADIOTHERAPY (CRT) FOR PATIENTS WITH SPINAL METASTASES Phase I BAY / An open-label, non-randomized, Phase I study to evaluate the effect of itraconazole on the pharmacokinetics of a single oral dose of roniciclib in patients with advanced solid tumors Phase I BAY / An open-label, non-randomized, Phase I study to evaluate the effect of itraconazole on the pharmacokinetics of a single intravenous dose of copanlisib in patients with advanced solid tumors Phase I GO29313 A PHASE I, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF MOXR0916 ADMINISTERED INTRAVENOUSLY AS A SINGLE AGENT TO PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS Phase I IND.214 A Phase I/II Study of MG1 Maraba/MAGE-A3 (MG1MA3), With and Without Adenovirus Vaccine, With Transgenic MAGE-A3 Insertion (AdMA3) in Patients With Incurable Advanced/Metastatic MAGE-A3-Expressing Solid Tumours Suspended NCT NCT NCT NCT NCT Phase I IND.226 A PHASE IB STUDY OF DURVALUMAB (MEDI4736) WITH OR WITHOUT TREMELIMUMAB IN PATIENTS WITH ADVANCED INCURABLE SOLID MALIGNANCIES RECEIVING STANDARD CHEMOTHERAPY REGIMENS Sarcoma AB04030 A prospective, multicenter, randomized, open-label, activecontrolled, 2-parallel group, phase III study to compare efficacy and safety of masitinib at 7.5 mg/kg/day to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumour in first line medical treatment NCT NCT

10 Sarcoma PHL-092:Ph II Cediranib Sunitinib in ASPS A Phase II Trial in Which Patients With Metastatic Alveolar Soft Part Sarcoma Are Randomized to Either Sunitinib or Cediranib Monotherapy, With Cross-Over at Disease Progression NCT