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North Shore Hematology Oncology Associates
Long Island's Premier Cancer Treatment Center

Research Protocols July 2011

BREAST STUDIES

Breast
Novartis CRAD0012301
Phase III, Double-Blind, Placebo-Controlled Study of Dail Everolimus in Combination with Trastuzumab and Vinorelbine in Pretreated Women with HER2/newu Over-Expressing Locally Advanced or Metastatic Breast Cancer
Breast TNBC
Roche Genentech OAM4861g
Phase III Randomized, Double-Blind Study Cmoparing METMAb + Bvacizub + Paclitaxel and MetMab + Placebo + Paclitaxel Relative to Placebo + Bevacizumab + Placlitaxel, in the 1st and 2nd Line Treatment of Metastatic or Locally Recurrent, Triple-Negative Breast Cancer
Breast Cancer
Amgen D-Care
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study of Denosumab as Adjuvant or Neoadjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence (D-Care)
Breast Cancer
Roche-Genetech TDM4997g
A Phase III Randomized, Multcenter, Two-Arm Open-Label Trial To Evaluate the Efficacy of T-DM1 cmopared with treatment of physician's choice in patients with HER2-Positive Metastatic Breast Cancer who have received at least two prior regimens of HER2-Directed Therapy
Breast Cancer
Roche BO22589/TDM4788g
Phase III, Study to evaluate the efficacy and the safety of T-DM1 Combined with pertuzumab vs T-DM1 (Blinded for Pertuzumab), vs Trastuzumab plus Taxane, as 1st Line Treatment in HEr-2 Positive Metastatic Breast Cancer.
Breast Cancer
Novartis CZOL446EUS147 Z-Act 1
Phase IV, Open-label, Study of the anti-cancer effects of Zoledronic Acid in combination with CHemotherapy +/- Avastin or Hormonal Therapy using Circulating Tumor Cell Measurements (CTC'S) in the 1st Line and 2nd Line Treatment of patients with HER2-negative MBC without Bone Metastases
Breast Cancer
Incyte INCB7839-204
A Phase I/II Study to assess the safety and therapeutic effect of INCB007839 in combination with Transtuzumab and vinorelbine metastatic HER2 + MBC
Breast Cancer
CDX-011
Phase III, Open Label, Study of CDX-011 vs Investigator Choice Chemotherapy in the 3rd-8th line Treatment of patients with BPNMB-expressing MBC
Breast Cancer
Novartis CZOL446E2352 Optimize 2
Phase II, Double-Blind, Study of the continued efficacy and safety of Zometa (every 4 weeks vs. every 12 weeks) in patients with documented bone metastases from Breast Cancer
Breast Cancer
Bayer BAY43-9006/12444
Phase III Double Blind Trial of Capecitabine plus Sorafenib vs. Capecitabine plus placebo in the t1st and 2nd Line Treatment of Locally advanced or Stage IV HER 2 Negative Breast Cancer

COLORECTAL STUDIES

Metastatic Colorectal Cancer
Genentech MAVVERICC ML 25710
A Randomized Phase II Study of Bevacizumab/mFOLFOX vs Bevacizumab/Folfiri with Biomarker Stratification in Patients with Previously Untreated Metastatic Colorectal Cancer
Metastatic Colorectal Cancer
Daiichi ARQ 197
Phase 1/2 Trial of Placebo-Controlled, ARQ 197 in Combination with Irinotecan and Cetuximab in the Treatment of Subjects wtih Metastatic Colorectal Cancer with Wild-Type DRAS who have received Front-Line Systemic Therapy

LUNG CANCER STUDIES

Lung
BioNumerik DMS32212R
Randomized, Multicenter, Double-Blind, Phase III Trial of Tavocept vs. Plaebo in Patients with Newly Diagnosed or Relapse Advanced Primary Adenocarcinoma of the Lung Treated with Docetaxel or Paclitaxel + Cisplatin
Lung
MEDIMUNE
Phase 1b/2 Randomized Study of MEDI-575 in combination with Carboplatin plus Paclitaxol vs. Carboplatin Plus alone in 1st Line Treatment of Advanced NSCLC

MYELOMA, LYMPHOMA, ITP

Multiple Myeloma
Keryx Perifosine 339
Phase III Randomized Study to assess the efficacy and Safety of Perifosine added to the Combinatino of Bortezomib and Dexamethasone in Multiple Myeloma Patients previously Treated with Bortezomib
Multiple Myeloma
Celgene Connect MM
The multiple Myeloma Disease Registry
ITP
Immunomedics IM-T-ha20-07
A phase I/II Study of Immunotherapy with Humanized Anti-CD20 Antibody, Immu-106 (hA20) in Adult Patients with Chronic ITP
B-Cell Non Hodgkins Lymphoma
Cell Therapeutics PIX306
Randomized, Multicenter Study Comparing Pixantrone + Rituximab with Gemcitabine + Rituximab in patients with Aggressive B-Cell NHL who have relpased after therapy with CHOP-R or an Equivalent Regimen and are inelligible for Stem Cell Transplant.
Follicular Lymphoma
10 GSK Home OMB113676
Phase III Randomized, Open Label Study of Single Agent Ofatumamab vs. Single Agent Rituximab in Follicular Lymphoma relapsed after Rituximab-Containing Therapy.

PANCREATIC

Pancreatic
Abraxis CA046
Phase III Randomized Study of Weekly ABI-007 Plus Gemcitabine vs. Gemcitabine Alnoe in 1st Line Treatment of Patients with Metastatic Pancreatic Adenocarcinoma.
Pancreatic
Clovis CO-101-001
Phase II Open-Label, Multicenter Study Comparing CO-1.01 with Gemcitabine as 1st Line Treatment in Metastatic Pancreatic Adenocarcinoma
Pancreatic
Clovis CO-101-001
Phase II Open-Label, Multicenter Study Comparing CO-1.01 with Gemcitabine as 1st Line Treatment in Metastatic Pancreatic Adenocarcinoma
Pancreatic
Peregrine PPHM 1002
Phase II Open Label, Trail of Gemcitabine with or without Bavituximab in 1st Line treatment of Metastatic Pancreatic Adenocarcinoma
Pancreatic
Theradex/KangLaiTE-USA
Phase 2b Randomized, Dose Escalation study of the Safety and exploratory Efficacy of Kanglaite Injection plus Gemcitabine (G+K) vs Gemcitabnie in the 1st line treatment of patients with Advanced Pancreatic Cancer

POLYCYTHEMIA VERA

Polycythemia Vera
Incyte INCB 18424-356
A Randomized Study of the JAK Inhibitor INCB018424 Tablets compared to Best Available Therapy in subjects wtih Polycythemia Vera Who are Resistant to Hydroxyurea

PROSTATE

Prostate
BMS CA184095
A Randomized, Double Blinded, Phase III Trial to Compare the efficacy of Ipilimumbab vs. Placebo in Asymptomatic or Minimally Symptomatic Patients with Mestastatic Chemo-Naive CRPC

OVARIAN

Ovarian
Morphotek MORab-003-004PS
Phase III Randomized, Double-Blind, Placebo-Controlled to assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination with Carboplatin and Taxane in subjects with Platinum-Sensitive Ovarian Cancer in First Relapse.
Ovarian
Morab0003-003PR
Phase III Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of MORAb-003 (Farletuzumab) in combination with Paclitaxel in subjects wtih Platinum-resistant or Refractory Relapsed Ovarian Cancer

SOLID TUMORS

Solid Tumors
Investigator Initiated
Phase I/II Study of Disulfiram, Capecitabine and Copper Gluconaet for the treatment of Refractory Solid Tumors.