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OHC Clinical Trials List V4 FOR MORE INFORMATION OR TO REFER A PATIENT TO ANY OF OUR CLINICAL TRIALS, PLEASE CONTACT NICOLE GIVEN, BS, OHC RESEARCH DEPARTMENT AT 1-800-710-4674 Phase 1 SOLID TUMOR BRE-261: GO29831 (BAM Only) A Phase Ib, Randomized, Two-Arm Study Evaluating the Safety and Phase Ib Pharmacokinetics of MPDL328A (Anti-PD-L1 Antibody) in Combination with Therapeutic Trastuzumab Emtansine or Trastuzumab and Pertuzumab in Patients with MPDL3280A provided HER2-Positive Breast Cancer GI-219: BBI608-246 (pending 1st Qtr) A Phase Ib Clinical Study of BBI608 in Combination with Standard Phase Ib Chemotherapies in Adult Patients with Advanced Gastrointestinal Cancer Therapeutic BBI608 provided REFMAL-381: ABI-007-ST-001 (BAM Only) Phase 1, Open-Label, Multi-Center, Safety Study of Nivolumab (BMS- Phase I 936558) in Combination with Nab-Paclitaxel Plus or Minus Gemcitabine in Therapeutic Pancreatic Cancer, Nab-Paclitaxel/Carboplatin in Stage IIIB/IV Non-Small Nivolumab, Abraxane provided Cell Lung Cancer or Nab-Paclitaxel in Recurrent Metastatic Breast Cancer REFMAL-404: TGR-1202-102 (BAM Only) A Phase I Study Evaluating the Safety and Efficacy of TGR 1202 Alone and in Phase I Combination with Either Nab-Paclitaxel + Gemcitabine or with FOLFOX in Therapeutic Patients with Select Relapsed or Refractory Solid Tumors TGR-1202 provided HEMATOLOGY MM-56: CFZ013 Phase Ib Study of Carfilzomib Administered Once Weekly in Combination Phase Ib with Lenalidomide and Dexamethasone in Subjects with Multiple Myeloma Therapeutic Carfilzomib provided Page 1 of 20 January 11, 2016 Molecular ProfIlIng PRO-02: ML28897 MY PATHWAY: An Open-Label Phase IIA Study Evaluating Phase IIa Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib, and Vismodegib in Therapeutic Patients who have Advanced Solid Tumors with Mutations or Gene Erlotinib, Vismodegib, Pertuzumab, Expression Abnormalities Predictive of Response to one of these Agents Trastuzumab, and Vemurafenib provided FGFR PRO-11: CBGJ398XUS04 Modular Phase II Study to Link Targeted Therapy to Patients with Pathway Phase II Activated Tumors: Module 6 – BGJ398 for Patients with Tumors with FGFR Therapeutic Genetic Alterations BGJ398 provided ALK & ROS1 PRO-12: CLDK378AUS23 (pending) Modular Phase II Study to Link Targeted Therapy to Patients with Pathway Phase II Activated Tumors: Module 7 – Ceritinib (LDK378) for Patients Whose Therapeutic Tumors have Aberrations in ALK or ROS1 LDK378 provided Bladder ClInical TrIals METASTATIC, AT LEAST SECOND-LINE GU-118: D2615C00001 An Open-Label, Non-Randomized, Multi-Drug, Biomarker-Directed, Multi- Phase Ib Center, Multi-Arm Phase Ib Study in Patients with Muscle Invasive Bladder Therapeutic Cancer (MIBC) who have Progressed on Prior Treatment (BISCAY) AZD4547 and MEDI4736 provided Page 2 of 20 January 11, 2016 Breast Clinical Trials STAGE I TO IIIA, ADJUVANT OR NEO-ADJUVANT BRE-270: SPI-GCF-301/501 (pending 3rd qtr) RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Phase III Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Supportive Care Docetaxel and Cyclophosphamide (TC) (ADVANCE-1) SPI-2012 provided STAGE IIB-III, TNBC BRE-273: FRV-002 (pending 3rd qtr) A Randomized Controlled Multicenter Phase IIA Trial to Evaluate the Safety Phase IIA and Immunogenicity of Two Doses of Vaccination with Folate Receptor Therapeutic Alpha Peptides with GM-CSF in Patients with Triple Negative Breast Cancer FRα and GM-CSF provided NEOADJUVANT, TNBC BRE-238: M14-011 A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Phase III the Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus Therapeutic the Addition of Carboplatin in Combination with Standard Neoadjuvant Veliparib/placebo, Carboplatin, Paclitaxel, Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects Doxorubicin and Cyclosphamide Provided with Early Stage Triple Negative Breast Cancer METASTATIC, FIRST-LINE, HER2+ BRE-261: GO29831 A Phase Ib, Randomized, Two-Arm Study Evaluating the Safety and Phase Ib Pharmacokinetics of MPDL328A (Anti-PD-L1 Antibody) in Combination with Therapeutic Trastuzumab Emtansine or Trastuzumab and Pertuzumab in Patients with MPDL3280A provided HER2-Positive Breast Cancer METASTATIC, FIRST-LINE, TNBC BRE-231: CDX011-04 A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Phase II Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Therapeutic Cancer (The “METRIC” Study) CDX-011 provided Page 3 of 20 January 11, 2016 BRE-258: WO29522 A Phase III, Multicenter, Randomized Placebo-Controlled Study of Phase III MPDL3280A (Anti-PD-L1 Antibody) in Combination with Nab-Paclitaxel Therapeutic Compared with Placebo with Nab-Paclitaxel for Patients with Previously MPDL3280A provided Untreated Metastatic Triple Negative Breast Cancer METASTATIC, SECOND-LINE BRE-261: GO29831 A Phase Ib, Randomized, Two-Arm Study Evaluating the Safety and Phase Ib Pharmacokinetics of MPDL328A (Anti-PD-L1 Antibody) in Combination with Therapeutic Trastuzumab Emtansine or Trastuzumab and Pertuzumab in Patients with MPDL3280A provided HER2-Positive Breast Cancer METASTATIC, SECOND-LINE, HER2+ BRE-240: 9785CL-1121 A Phase 2a, Multicenter, Open-Label Study to Assess the Efficacy and Phase IIa Safety of Enzalutamide with Trastuzumab in Subjects with HER2+ Therapeutic Metastatic or Locally Advanced Breast Cancer Enzalutamide provided METASTATIC, SECOND-LINE, TNBC BRE-231: CDX011-04 A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Phase II Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Therapeutic Cancer (The “METRIC” Study) CDX-011 provided METASTATIC, THIRD-LINE, HER2+ BRE-240: 9785CL-1121 A Phase 2a, Multicenter, Open-Label Study to Assess the Efficacy and Phase IIa Safety of Enzalutamide with Trastuzumab in Subjects with HER2+ Therapeutic Metastatic or Locally Advanced Breast Cancer Enzalutamide provided BRE-249: MM-302-02-02-03 A Randomized, Multicenter, Open Label Study of MM-302 plus Phase II Trastuzumab vs. Chemotherapy of Physician’s Choice plus Trastuzumab in Therapeutic Anthracycline Naïve Patients with Locally Advanced/Metastatic HER2- MM-302 provided Positive Breast Cancer Page 4 of 20 January 11, 2016 BRE-261: GO29831 A Phase Ib, Randomized, Two-Arm Study Evaluating the Safety and Phase Ib Pharmacokinetics of MPDL328A (Anti-PD-L1 Antibody) in Combination with Therapeutic Trastuzumab Emtansine or Trastuzumab and Pertuzumab in Patients with MPDL3280A provided HER2-Positive Breast Cancer METASTATIC, THIRD-LINE, TNBC BRE-231: CDX011-04 A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Phase II Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Therapeutic Cancer (The “METRIC” Study) CDX-011 provided METASTATIC, REFRACTORY, HER2+ BRE-240: 9785CL-1121 A Phase 2a, Multicenter, Open-Label Study to Assess the Efficacy and Phase IIa Safety of Enzalutamide with Trastuzumab in Subjects with HER2+ Therapeutic Metastatic or Locally Advanced Breast Cancer Enzalutamide provided BRE-249: MM-302-02-02-03 A Randomized, Multicenter, Open Label Study of MM-302 plus Phase II Trastuzumab vs. Chemotherapy of Physician’s Choice plus Trastuzumab in Therapeutic Anthracycline Naïve Patients with Locally Advanced/Metastatic HER2- MM-302 provided Positive Breast Cancer BRE-261: GO29831 A Phase Ib, Randomized, Two-Arm Study Evaluating the Safety and Phase Ib Pharmacokinetics of MPDL328A (Anti-PD-L1 Antibody) in Combination with Therapeutic Trastuzumab Emtansine or Trastuzumab and Pertuzumab in Patients with MPDL3280A provided HER2-Positive Breast Cancer METASTATIC, HR+ BRE-252: LEE011E2301 A Phase III Randomized, Double-Blind, Placebo-Controlled Study of LEE011 Phase III or Placebo in Combination with Tamoxifen and Goserelin for the Treatment Therapeutic of Premenopausal Women with Hormone Receptor Positive Advanced LEE011 provided Breast Cancer who have Received No Prior Therapy for Advanced Disease (MONALEESA-7) Page 5 of 20 January 11, 2016 BRE-266: GO29689 A Phase II, Open-Label Randomized Study of GDC-0810 versus Fulvestrant Phase II in Advanced or Metastatic Breast Cancer in Patients Resistant to Therapeutic Aromatase Inhibitor Therapy GDC-0810 provided BRE-267: CBYL719C2301 (pending 1st Qtr) A Phase III Randomized Double-Blind, Placebo-Controlled Study of Alpelisib Phase III in Combination with Fulvestrant versus Placebo plus Fulvestrant as First- or Therapeutic Second-Line Treatment for Post-Menopausal Women and Men with Alpelisib/placebo provided Hormone Receptor Positive, HER2-Negative, Advanced Breast Cancer Previously Treated with Endocrine Therapy Cholangio Clinical Trials GI-219: BBI608-246 (pending 1st Qtr) A Phase Ib Clinical Study of BBI608 in Combination with Standard Phase Ib Chemotherapies in Adult Patients with Advanced Gastrointestinal Cancer Therapeutic BBI608 provided Colorectal/Rectal Clinical Trials METASTATIC, FIRST-LINE GI-200: BP29262 A Phase II, Multicenter, Randomized, Double-Blind Study to Evaluate the Phase II Efficacy and Safety of RO5520985 plus FOLFOX versus Bevacizumab plus Therapeutic FOLFOX in Patients with Previously Untreated Metastatic Colorectal Cancer RO5520985 and Bevacizumab provided REFMAL-404: TGR-1202-102 A Phase I Study Evaluating the Safety and Efficacy of TGR 1202 Alone and in Phase I Combination with Either Nab-Paclitaxel + Gemcitabine or with FOLFOX in Therapeutic Patients with Select Relapsed or Refractory Solid Tumors TGR-1202 provided Page 6 of 20 January 11, 2016 METASTATIC, SECOND-LINE GI-219: BBI608-246
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