CLINICAL TRIALS ACC. Jul 2016
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1 CLINICAL TRIALS ACC Jul 2016 Glioblastoma BRAIN A A Phase II/III Randomized Trial of Veliparib or Placebo in Combination With Temozolomide in Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation BRCA ½,HER2- BREAST Alliance A A randomized double-blind placebo controlled study of subcutaneous testosterone in the adjuvant treatment of Postmenopausal women in aromatase inhibitor induced arthralgias NSABP B-55 A Randomized Double-Blind Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Vs Placebo as Treatment in Patients with Germline BRCA ½ Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Chemotherapy ER+, HER2- Sandpiper GO A Phase III, Double-Blind, Placebo- Controlled, Randomized Study Of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant In Postmenopausal Women With Estrogen Receptor-Positive And Her2-Negative Locally Advanced Or Breast Cancer Who Have Disease Recurrence Or Progression During Or After Aromatase Inhibitor Therapy Post Neoadjuvant Triple-negative Postmenopausal ER+, HER2- EA A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Observation in Patients with Residual Triple-Negative Basal-Like Breast Cancer following Neoadjuvant Chemotherapy (COMING SOON ADDITION OF CAPECITABINE ARM REPLACING OBSERVATION ARM) A A randomized Phase II Trial of Tamoxifen vs Z- Endoxifen HCL in Postmenopausal Women with Estrogen Receptor Positive, Her2- Breast Cancer OPEN Page 1 of 5
2 Triple negative HER2 + TNBC 1 st line metastatic HR+, HER2+ HR+/HER2- Locally advanced or Pretreated Locally Advanced or HER2+ TNBC/Ovarian HER 2 + locally advanced or metastatic Advanced melanoma BREAST (CON T) NRG-BR003 - A Randomized Phase III Trial of Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or Without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer PT S MUST BE SEEN IN ATLANTA, FORSYTH AND/OR ALPHARETTA FOR RADIATION RTOG 1119 Phase II Randomized Study of Whole Brain Radiotherapy In Combination With Concurrent Lapatinib In Patients With Brain Metastasis From HER2-Positive Breast Cancer- DOMPE REP Phase 2 study of Paclitaxel +/- Reparixin as Front-Line Therapy for Triple-Negative Breast Cancer (NO de novo pts) monarcher - Abermaciclib + Trastuzumab + Fulvestrant vs Abemaciclib + Trastuzumab vs SOC Systemic Tx + Trastuzumab for HR+, HER2+ Locally Advanced/ Breast Cancer TRINITI-1 - Phase 2 Study of Ribociclib in Combination with Everoliums + Exemestane in the Treatment of Postmenopausal Women and Men with HR+, HER2- Locally Advanced or Breast Cancer Following Progression on a CDK 4/6 Inhibitor ONT Phase 2 Randomized Double Blinded Controlled Study of ONT-380- vs Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or HER2+ Breast Carcinoma Tesaro - Niraparib + Pembrolizumab for Patients with Advanced or Triple-Negative Breast Cancer and in Patients with Recurrent Ovarian Cancer KATE2 - A Randomized, Double-Blind, Phase II of the Efficacy and Safety of Trastuzumab Emtansine in Combo w/atezolizumab or Atezolizumab-placebo in Patients w/her2 + Locally Advanced or Metastitic Breast Cancer Who Have Received Prior Trastuzumab and Taxane Based Therapy MELANOMA Elios C Autologous tumor lysate (TL) + yeast cell wall particles (YCWP) + Dendritic cells (DC) vaccine vs unloaded YCWP +DC in stage III and stage IV (resected) melanoma to prevent recurrence. Page 2 of 5
3 Unresectable Stage III or IV Resected Prostate 1 st line high risk myeloma MELANOMA (CON T) EA Randomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients with Unresectable Stage III or Stage IV S A Phase III Randomized Trial Comparing High Dose Interferon to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Multi-center phase I/IIa trial of an autologous tumor lysate (TL) + yeast cell wall particles (YCWP) + dendritic cells (DC) vaccine in addition to standard of care checkpoint inhibitor of choice in metastatic melanoma patients with stable or slowly progressing disease. GU Alliance A A Phase III Trial of Enzalutamide Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Prostate Cancer. HEME E1A11 Randomized Phase III Trial of Bortezomib, Lenalidomide and Dexamethasone (VRd) Vs Carfilzomib, Lenalidomide, Dexamethasone (CRd) Followed by Limited or Indefinite Duration Lenalidomide Maintenance in Patients with Newly Diagnosed Symptomatic Multiple Myeloma 1 st line SGN A Phase 2, Single-arm, -label Study of Singleagent Brentuximab Vedotin for Front-line Therapy of Hodgkin Lymphoma (HL) in Adults Age 60 and Above Refractory or Relapsed Myeloma Specimen Collection Newly Diagnosed Diffuse Large B Cell Lymphoma Newly Diagnosed Multiple Myeloma MK A Phase III Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrmm) Dana Farber Precursor Heme Study of Precursor Hematological Malignancies to Assess the Relationship between Molecular Events of Progression and Clinical Outcome E Randomized Phase II Label Study of Lenalidomide R-CHOP (R2CHOP) vs RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients With Newly Diagnosed Diffuse Large B Cell Lymphoma PANORAMA 4 - Randomized, Phase II trial evaluating the efficacy and safety of lenalidomide, bortezomib and dexamethasone (RVD) with or without panobinostat in transplant eligible, newly diagnosed Multiple Myeloma Page 3 of 5
4 2 nd line squamous Advanced with intent to treat (SCLC or NSCLC of any stage) at any treatment time point Genotyping Non Squamous NSCLC Extensive Stage SCLC Lung (NSCLC) LUNG SWOG S1400 -Phase II/III biomarker driven master protocol for second line treatment of squamous cell lung cancer. Patients will be assigned to one of five arms based on the biomarker analysis of their tissue. NSH ALCMI - Collaborative Advanced Stage Tissue Lung Cancer (CASTLE) Network - Aims to collect, process, store, and distribute tumor-related and normal biospecimens from advanced stage lung cancer patients NSH1109 ALCMI Young Lung - <40 yrs of age Comprehensive genomic analysis of young lung cancer patients samples to facilitate delivery of targeted therapies (Tissue samples & labwork only) Alchemist Screen (A151216) Cancer Enrichment Marker Identification and Sequencing Trial Alchemist EGFR (A081105) Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant NSCLC Alchemist ALK (E4512) A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib vs Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein Alchemist ANVIL EA Nivolumab in Resected Lung Cancers (ANVIL): A Randomized Phase III Study of Nivolumab After Surgical Resection and Chemotherapy in Non-Small Cell Lung Cancers GO A Phase III, -Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination with Carboplatin or Cisplatin + Pemetrexed Compared with Carboplatin or Cisplatin + Pemetrexed in Patients Who Are Chemotherapy-Naive and Have Stage IV Non- Squamous Non-Small Cell Lung Cancer PINNACLE - A Phase 1b/2 Study of OMP-59R5 in Combination with Etoposide and Platinum Therapy in Subjects with Untreated Extensive Stage Small Cell Lung Cancer PTS MUST BE SENT TO ATLANTA, FORSYTH AND/OR ALPHARETTA FOR RADIATION RTOG A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer (NSCLC) Page 4 of 5
5 1 st Line NSCLC EGFR Mutation First line, Met, Squamous NSCLC Solid tumor and lymphomas LUNG (CON T) SOLAR - An -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 A Randomized, Double-Blind, Phase III Study of Carboplatin- Paclitaxel/Nab-Paclitaxel Chemotherapy with or without Pembrolizumab (MK-3475) in First Line Squamous Non-small Cell Lung Cancer Subjects MOLECULAR EAY131 - MATCH Molecular analysis for Therapy Choice Basket trial with multiple sub-protocols with various single and combination treatments OPEN Page 5 of 5
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