Maryland Oncology Hematology

Maryland Oncology Hematology Clinical Trials

Current Clinical Trials at Maryland Oncology Hematology, P.A.

Protocol List as of December 2016

BREAST

USO 13033 – A Phase II, Randomized, Parallel Group Study to Compare Alisertib in Combination with Paclitaxel vs. Paclitaxel Alone in Patients with Metastatic or Locally Recurrent Breast Cancer with histologic confirmation: ER+, HER2- invasive breast cancer (any PgR status) or poorly differentiated and/or invasive TNBC. 1st – 2nd line on metastatic setting.

USO 15130 – A Phase 2 Open Label, Multi-Center, Multinational Study Investigating the Efficacy and Safety of GTx-024 On Advanced, Androgen Receptor-Positive Triple Negative Breast Cancer (AR+ TNBC)

USO 11025 (STAR TRIAL)A Phase II Multicenter Single-arm Study of BKM120 plus Capecitabine for Breast Cancer Patients with Brain Metastasis.

 

LUNG

USO 15014: GO29437: A phase Ill, open-label, multicenter, randomized study evaluating the efficacy and safety of mpdl3280a (anti-pd-l1 antibody) in combination with carboplatin + paclitaxel or mpdl3280a in combination with carboplatin +nab-paclitaxel versus carboplatin + nab-paclitaxel in chemotherapy naive patients with stage IV squamous NSCLC.

USO 13172: Observational/non-interventional study for metastatic NSCLC AND EXTENSIVE DISEASE SCLC

USO 14158: CA209370:  A Master Protocol of Phase 1/2 Studies of Nivolumab in Advanced NSCLC Using Nivolumab as Maintenance after Induction Chemotherapy or as First-line Treatment Alone or in Combination with Standard of Care Therapies

GO29527 – A Phase III, Open label, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti-PDL1 Antibody) Compared With Standard of Care Following Adjuvant Cisplatin-based Chemotherapy in PDL-1 Selected Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer-

 

ADVANCED/METASTATIC MALIGNANCIES

USO 16041 – An Open-label Phase 2 Multi-cohort Trial of Nivolumab in Advanced or Metastatic Malignancies Investigational Product(s), Dose and Mode of Administration, Duration of Treatment with Investigational

 

CLL

USO 15061 – A randomized, multicenter, open-label, 3 arm phase 3 study of obinutuzumab in combination with chlorambucil, ACP-196 in combination with obinutuzumab, and ACP-196 monotherapy in subjects with previously untreated chronic lymphocytic leukemia

ACE-CL-006A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase 3 Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia

UNITY trial – A Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination with TGR-1202 Compared to Obinutuzumab in Combination with Chlorambucil in Patients with Chronic Lymphocytic Leukemia.

 

Large B-CELL Lymphoma – ROBUST trial – Phase III Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Compare the Efficacy and Safety of Lenalidomide (CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects with Previously Untreated, Non-Germinal Center Type Diffuse Large B-cell Lymphoma

MDS/AML OBSERVATIONAL STUDY – Connect MDS and AML Disease registry for newly diagnosed MDS/AML patients.

 

Multiple Myeloma

USO 16035 – global, prospective, non-interventional, observational study of presentation, treatment patterns, and outcomes in multiple myeloma patients – the INSIGHT-MM study – start Nov2016

USO 16084 -Daratumumab plus Cyclophosphamide, Bortezomib and Dexamethasone (Dara-CyBorD)in Previously Untreated and Relapsed Subjects with Multiple Myeloma. Start Nov2016

 

SUPPORTIVE

USO 15026 – Efficacy and Safety of Rivaroxaban Prophlaxis Compared to Placebo in Ambulatory Cancer Patients at High Venous Thromboembolism Risk Undergoing Chemotherapy for Mixed Malignancies (39039039STM4001).

Gastric

USO 15089 – A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5745 Combined with mFOLFOX6 as First Line Treatment in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma – possible start Dec2016

 

For additional clinical trial information contact
Cheryl A. Young, RN, BSN
Clinical Research Manager
Office (410) 964-2212 ext 1137
Cheryl.Young@USOncology.com