FOR MORE INFORMATION OR TO REFER A PATIENT TO ANY OF OUR CLINICAL TRIALS, CONTACT NICOLE GIVEN, BS, OHC RESEARCH DEPARTMENT AT 800-710-4674 ext. 27110
Molecular Profiling PRO-02: ML28897 MY PATHWAY: An Open-Label Phase IIA Study Evaluating Trastuzumab/ Phase IIA Pertuzumab, Erlotinib, Vemurafenib, and Vismodegib in Patients who Have Therapeutic Advanced Solid Tumors with Mutations or Gene Expression Abnormalities Trastuzumab, Pertuzumab, Erlotinib, Predictive of Response to One of These Agents Vemurafenib, Vismodegib provided
PRO-03: CBKM120ZUS40 (pending) Modular phase II study to link targeted therapy to patients with pathway Phase II activated tumors: Module 1 – BKM120 for patients with PI3K-activated Therapeutic tumors BKM120 provided
PRO-04: CTKI258AUS26 Modular phase II study to link targeted therapy to patients with pathway Phase II activated tumors: Module 2 – Dovitinib for patients with tumor pathway Therapeutic activations inhibited by dovitinib including tumors with mutations or Dovitinib provided translocations of FGFR, PDGFR, VEGF, cKIT, FLT3, CSFR1, Trk and RET
PRO-06: CMEK162AUS11 (pending) Modular phase II study to link targeted therapy to patients with pathway Phase II activated tumors: Module 3 – MEK162 for patients with RAS/RAF/MEK Therapeutic activated tumors MEK162 provided
PRO-07: CLGX818AUS03 (pending) Modular phase II study to link targeted therapy to patients with pathway Phase II activated tumors: Module 4 – LGX818 for patients with BRAFV600 mutated Therapeutic tumors LGX818 provided
PRO-08: CLDE225XUS20 (pending) Modular phase II study to link targeted therapy to patients with pathway Phase II activated tumors: Module 5 – LDE225 for patients with PTCH1 and SMO Therapeutic mutated tumors LDE225 provided
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Bladder Clinical Trials GU-113: GO29293 ( Cohort 2 CLOSED) A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients with Phase II Locally Advanced or Metastatic Urothelial Bladder Cancer Therapeutic MPDL3280A provided
Brain Clinical Trials SECOND-LINE CNS-22: STML-701-0114 (pending 4th Qtr) A Phase ½ Study of SL-701, a Subcutaneously Injected Multivalent Gilioma- Phase I/II Associated Antigen Vaccine, in Adult Patients with Recurrent Glioblastoma Therapeutic Multiforme SL-701, Montanide emulsion, imiquimod topical cream 5%, GM-CSF provided
Breast Clinical Trials ADJUVANT, HER2+ BRE-186 (Cohort A & B closed) Phase 2 Trial of Eribulin in Patients Who do Not Achieve Pathologic Phase II Complete Response (pCR) Following Neoadjuvant Chemotherapy Therapeutic Eribulin provided
BRE-233: BO28407 A Randomized, Multicenter, Open-Label Trial Comparing Chemotherapy Phase III plus Trastuzumab plus Pertuzumab versus Chemotherapy plus Therapeutic Trastuzumab Emtansine plus Pertuzumab as Adjuvant Therapy in Patients TDM-1 provided with Operable HER2-Positive Primary Breast Cancer
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NEOADJUVANT, TNBC BRE-238: M14-011 A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Phase III Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Therapeutic Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Veliparib/Carboplatin provided Standard Neoadjuvant Chemotherapy in Subjects with Early Stage Triple Negative Breast Cancer (TNBC)
FIRST-LINE, HR+, HER2- BRE-234: CLEE011A2301 Phase III A Randomized, Double-Blind, Placebo-Controlled Study of LEE011 in Therapeutic Combination with Letrozole for the Treatment of Postmenopausal Women LEE011 provided with Hormone Receptor Positive, HER2-Negative, Advanced Breast Cancer who Received no Prior Therapy for Advanced Disease
METASTATIC, FIRST-LINE, TNBC BRE-223: ABI-007-MBC-001 Phase 2/3, Multi-center, Open-Label, Randomized Study of Weekly Nab- Phase II/III Paclitaxel (ABRAXANE) in Combination with Gemcitabine or Carboplatin, Therapeutic Compared to Gemcitabine/Carboplatin, as First-Line Treatment in Subjects Nab-Paclitaxel provided with ER, PgR, and HER2 Negative (Triple Negative) Metastatic Breast Cancer
BRE-231: CDX011-04 A Randomized Multicenter Phase II Study of CDX-011 (CR011-vcMMAE) in Phase II Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Therapeutic Cancer CDX-011 provided
BRE-242: INCB 18424-268 A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Phase II Combination with Capecitabine in Subjects With Advanced or Metastatic Therapeutic HER2-Negative Breast Cancer Ruxolitinib/placebo provided
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METASTATIC, SECOND-LINE, HER2+ BRE-249: MM-302-02-02-03 (pending 3rd qtr) 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
METASTATIC, REFRACTORY, ER/PR POSITIVE BRE-229: MDV3100-12 A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study of Efficacy and Safety of Enzalutamide in Combination with Therapeutic Exemestane in Patients with Advanced Breast Cancer That is Estrogen or Enzalutamide/placebo & Exemestane Progesterone Receptor-Positive and HER2-Normal provided
BRE-242: INCB 18424-268 A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Phase II Combination with Capecitabine in Subjects With Advanced or Metastatic Therapeutic HER2-Negative Breast Cancer Ruxolitinib/placebo provided
SECOND-LINE, HER2-, HR+ BRE-241: I3Y-MC-JPBN A Phase 2 Study of LY2835219 for Patients with Previously Treated Phase II Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer Therapeutic LY2835219 provided
METASTATIC, REFRACTORY, HER2+
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BRE-200 (Phase 1 open at BAM only) A Phase II Study with Lead-In Safety Cohort of Cabazitaxel plus Lapatinib as Phase II Therapy for HER2-Positive Metastatic Breast Cancer Patients with Therapeutic Intracranial Metastases Cabazitaxel/Lapatinib provided
BRE-240: 9785-CL-1121 Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Phase II Enzalutamide with Trastuzumab in Subjects with HER2+ AR+ Metastatic or Therapeutic Locally Advanced Breast Cancer Enzalutamide provided
METASTATIC, REFRACTORY, TNBC BRE-231: CDX011-04 A Randomized Multicenter Phase II Study of CDX-011 (CR011-vcMMAE) in Phase II Patients with Metastatic, GPNMB Over-Expressing, Triple Negative Breast Therapeutic Cancer CDX-011 provided
BRE-242: INCB 18424-268 A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Phase II Combination with Capecitabine in Subjects With Advanced or Metastatic Therapeutic HER2-Negative Breast Cancer Ruxolitinib/placebo provided
Colorectal/Rectal Clinical Trials METASTATIC, FIRST-LINE GI-181: ML28442 STEAM (Sequencing Triplet with Avastin and Maintenance): FOLFOXIRI/ Phase II Bevacizumab Regimens (Concurrent and Sequential) vs. FOLFOX/ Therapeutic Bevacizumab in First-Line Metastatic Colorectal Cancer Bevacizumab provided
GI-200: BP29262 (pending 4th qtr) A Phase II, Multicenter, Randomized, Double-Blind Study to Evaluate the Phase II Efficacy and Safety of RO55290985 Plus FOLFOX Versus Bevacizumab Plus Therapeutic FOLFOX in Patients with Previously Untreated Metastatic Colorectal Cancer RO5520985, Bevacizumab provided
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METASTATIC, SECOND-LINE GI-198: INCB 18424-267 (pending 4th Qtr) A Randomized, Double-Blind Study of Ruxolitinib or Placebo in Phase III Combination with Regorafenib in Subjects with Relapsed or Refractory Therapeutic Metastatic Colorectal Cancer Ruxolitinib/placebo provided
METASTATIC, REFRACTORY GI-190: 2012-PT023 (ON HOLD) A Pivotal Phase III Study to Evaluate Overall Survival using MABp1 as a Phase III Monotherapy in Metastatic Colorectal Cancer Patients with Cachexia Therapeutic MABp1 provided
Esophageal/Gastric Clinical Trials NEOADJUVANT GI-166 A Phase II Study with Lead-in Safety Cohort of 5-Fluorouracil, Oxaliplatin Phase II and Lapatinib in Combination with Radiation Therapy as Neoadjuvant Therapeutic Treatment for Patients with Localized HER2 Positive Esophagogastric Lapatinib provided Adenocarcinoma
METASTATIC, FIRST-LINE GI-185: BO25114 A Double-Blind, Placebo-Controlled, Randomized, Multicenter Phase III Phase III Study Evaluating the Efficacy and Safety of Pertuzumab in Combination Therapeutic with Trastuzumab and Chemotherapy in Patients with HER2-Positive Pertuzumab/placebo, Trastuzumab Metastatic Gastroesophageal Junction and Gastric Cancer provided
METASTATIC, SECOND-LINE
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GI-202: C26002 A Phase 2 Trial of MLN0264 in Previously Treated Patients with Metastatic Phase II or Recurrent Adenocarcinoma of the Stomach or Gastroesophageal Therapeutic Junction Expressing Guanylyl cyclase (GCC) MLN0264 provided
Kidney Clinical Trials METASTATIC, FIRST-LINE GU-108: WO29074 A Phase II, Randomized Study of MPDL2380A Administered as Phase II Monotherapy or in Combination with Bevacizumab versus Sunitinib in Therapeutic Patients with Untreated Advanced Renal Cell Carcinoma MPDL3280A provided
Lung – Non Small Cell Clinical Trials LUN-265: CA209118 Observational Study Protocol: Lung Cancer Molecular Profiling and Clinical Observational Outcomes in U.S. Community Oncology Practices
STAGE IIIB/IV, FIRST-LINE LUN-229 Double-Blind Randomized Phase II Trial of Carboplatin and Pemetrexed Phase II with or without OGX-427 in Patients with Previously Untreated Stage IV Therapeutic Non-Squamous Non-Small Cell Lung Cancer (Spruce Clinical Trials) OGX-427 provided
LUN-261: D6011C00002 (ON HOLD) Double-Blind Randomized Phase II Trial of Carboplatin and Pemetrexed Phase II with or without AZD1775 in Patients with Previously Untreated Stage IV Therapeutic Non-Squamous Non-Small-Cell Lung Cancer AZD1775 provided Page 7 of 14 November 5, 2014
LUN-263: ABI-007-NSCL-003 A Phase III, Randomized, Open-Label, Crossover, Multi-Center, Safety and Phase III Efficacy Study to Evaluate Nab-Paclitaxel (ABRAXANE) as Maintenance Therapeutic Treatment After Induction with Nab-Paclitaxel Plus Carboplatin in Subjects Nab-Paclitaxel provided with Squamous Cell Non-Small Cell Lung Cancer (NSCLC)
STAGE IIIB/IV, THIRD-LINE LUN-283: D4191C0004 (pending 4th Qtr) A Phase III, Open label, Randomised, Multi-centre, International Study of Phase III MEDI4736 versus Standard of Care in Patients with Locally Advanced or Therapeutic Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received MEDI4736 provided at Least Two Prior Systemic Treatment Regimens Including One Platinum- based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC)
LOCALLY ADVANCED, UNRESECTABLE LUN-282: D419C10001 (pending 4th qtr) A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, Phase III International Study of MEDI4736 as Sequential Therapy in Patients with Therapeutic Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who MEDI4736 Have Not Progressed Following Definitive, Platinum-Based, Concurrent Chemoradiation Therapy (PACIFIC)
RELAPSED/REFRACTORY LUN-214 Phase II Trial of Erlotinib and BMK120 in Patients with Advanced Non- Phase II Small-Cell Lung Cancer Previously Sensitive to Erlotinib Therapeutic BKM120 provided
LUN-238: AT13387-05 A Study of HSP90 Inhibitor AT13387 Alone and in Combination with Phase II Crizotinib in the Treatment of Non-Small Cell Lung Cancer (NSCLC) Therapeutic AT13387 Page 8 of 14 November 5, 2014
LUN-262: D6011C00001 A Lead-in Phase II Multicentre, Randomized, Double-Blind Study Phase II Comparing AZD1175 plus Docetaxel and Placebo plus Docetaxel in Therapeutic Previously Treated Patients with p53 Non-Small-Cell Lung Cancer AZD1175 provided
LUN-264: PPHM 1202 SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Phase III Multicenter Trial of Bavituximab Plus Docetaxel versus Docetaxel Alone as Therapeutic Second-Line Therapy in Patients with Stage IIIB/IV Non-Squamous Non Bavituximab provided Small-Cell Lung Cancer
LUN-270: D4191C00003 A Phase II, Non-comparative, Open label, Multi-centre, International Study Phase II of MEDI4736, in Patients with Locally Advanced or Metastatic Non-Small Therapeutic Cell Lung Cancer who have Received at Least Two Prior Systemic MEDI4736 provided Treatment Regimens including One Platinum-based Chemotherapy Regimen (ATLANTIC)
LUN-272: CA209153 A Phase IIIb/IV Safety Trial of Nivolumab (BMS-936558) in Subjects with Phase IIIb/IV Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed Therapeutic During or After Receiving at Least One Prior Systemic Regimen Nivolumab provided
METASTATIC, SECOND- OR THIRD-LINE LUN-284: I3Y-MC-JPBK (pending 4th qtr) A Randomized Phase 3 Study of LY2835219 versus Erlotinib in Patients with Phase III Stage IV NSCLC with a detectable KRAS mutation who have progressed Therapeutic after platinum-based chemotherapy LY2835219 provided
Lung – Small Cell Clinical Trials LUN-265: CA209118 Observational Study Protocol: Lung Cancer Molecular Profiling and Clinical Observational Outcomes in U.S. Community Oncology Practices
EXTENSIVE STAGE, FIRST-LINE
Ovarian Clinical Trials Page 9 of 14 November 5, 2014
PHASE 1 REFMAL-226: X82-CLI-101 (BAM only; ON A Phase I, First in Human Dose Escalation Study to Evaluate the Safety, HOLD) Tolerability, and Pharmacokinetics of X-82 in Subjects with Advanced Solid Phase I Tumors Therapeutic X-82 provided
SECOND-LINE GYN-42: EMR200066_012 (ON HOLD) Phase II Randomized Double-Blind Placebo Controlled Trial of Combination Phase II of Pimasertib with SAR245409 or of Pimasertib with SAR245409 Placebo in Therapeutic Subjects with Previously Treated Unresectable Low Grade Ovarian Cancer SAR245409 provided
THIRD-LINE GYN-41: ET743-OVC-3006 A Randomized, Open-Label Study Comparing the Combination of YONDELIS Phase III and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Therapeutic Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Yondelis provided Tube
Pancreas Clinical Trials ADJUVANT GI-194: ABI-007-PANC-003 A Phase 3, Multicenter, Open-Label, Randomized Study of nab-Paclitaxel Phase III Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Therapeutic Subjects with Surgically Resected Pancreatic Adenocarcinoma Nab-Paclitaxel provided
FIRST-LINE GI-183: 59R5-002 A Phase 1b/2 Study of OMP-59R5 in Combination with Nab-Paclitaxel and Phase II Gemcitabine in Subjects with Previously Untreated Stage IV Pancreatic Therapeutic Cancer ALPINE: Antibody therapy in first-Line Pancreatic cancer OMP-59R5 provided Investigating anti-Notch Efficacy and safety
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SECOND-LINE GI-199: INCB 18424-363 A Randomized, Double-Blinded Phase II Trial of Gemcitabine Plus Nab- Phase III Paclitaxel Combined with OGX-427 or Placebo in Patients With Metastatic Therapeutic Pancreatic Cancer (The Rainier Trial) Ruxolitinib/placebo provided
GI-203: C26003 A Phase 2 Trial of MLN0264 in Previously Treated Patients with Advanced Phase II or Metastatic Pancreatic Adenocarcinoma Expressing Guanylyl Cyclase C Therapeutic (GCC) MLN0264 provided
Prostate Clinical Trials PHASE 1 GU-99: LOI GU 2012-01 (pending 4th Qtr) Enzalutamide plus Everolimus in Men with Metastatic Castrate-Resistant Phase I Prostate Cancer and Previous Treatment with Docetaxel: A Phase I Study Therapeutic with a Maximum Tolerated Dose Expansion Cohort Everolimus, Enzalutamide provided
Hematological Malignancies HEMREF-31: TGR-1202-101 (pending) A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR- Phase I 1202 in Patients with Relapsed or Refractory Hematologic Malignancies Therapeutic (TGR-1202-101) TGR-1202 provided
LYM-89: GS-US-339-0102 A Phase 2 Open Label, Study Evaluating the Efficacy , Safety, Tolerability, Phase II and Pharmacodynamics of GS-9973 in Patients with Relapsed or Refractory Therapeutic Hematologic Malignancies GS-9973
CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) Page 11 of 14 November 5, 2014
FIRST-LINE CLL-32: GS-US-312-0123 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Phase III the Efficacy and Safety of Idelalisib in Combination with Bendamustine and Therapeutic Rituximab for Previously Untreated Chronic Lymphocytic Leukemia IDELA/placebo provided
Relapsed/Refractory CLL-18: LOI CLL 2011-01 Phase II Trial: Rapid infusion of Ofatumumab in Patients with Previously Phase II Treated CLL Therapeutic Ofatumumab
CLL-30: IPI-145-07 A Phase 3 Study of IPI-145 versus Ofatumumab in Patients with Relapsed Phase III or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Therapeutic Lymphoma IPI-145, Ofatumumab provided
CLL-31: IPI-145-12 A Study of IPI-145 and Ofatumumab in Patients with Chronic Lymphocytic Rollover Leukemia/Small Lymphocytic Lymphoma Previously Enrolled in Study IPI- Therapeutic 145-07 (CLL-30 Rollover Study) IPI-145, Ofatumumab provided
CHRONIC MYELOGENOUS LEUKEMIA (CML) SECOND-LINE CML-18: CA180-399 An Open Label, Randomized Phase IV Study of Dasatinib vs. Imatinib in the Phase IV Treatment of Subjects with Chronic Phase Chronic Myeloid Leukemia who Therapeutic Have not Optimally Responded to 3 Months of Therapy with 400 mg Dasatinib provided Imatinib
HODGKINS DISEASE FIRST-LINE
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LYM-84: C25003 A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Phase III Frontline Therapy in Patients with Advanced Classical Hodgkin Lymphoma Therapeutic Brentuximab vedotin provided
NON-HODGKIN’S LYMPHOMA-FOLLICULAR RELAPSED/REFRACTORY LYM-87: IPI-145-06 A Phase 2 Study of IPI-145 in Subjects with Refractory Indolent NHL Phase II Therapeutic IPI-145 provided
MULTIPLE MYELOMA FIRST LINE E1A11 E1A11, Randomized Phase III Trial of Bortezomib, LENalidomide and Phase III Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide, and Therapeutic Dexamethasone (CRd) Followed by Limited or Indefinite DURation Carfilzomib provided Lenalidomide MaintanANCE in Patients with Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE) Principal
RELAPSED/REFRACTORY MM-27 Phase I/II Study of the Combination of Panobinostat and Carfilzomib in Phase I/II Patients with Relapsed/Refractory Multiple Myeloma Therapeutic Panobinostat and Carfilzomib
MM-42: LOI BMT2012-002 A Phase I/II study evaluating maintenance MLN9708 following an Phase I/II allogeneic transplant for multiple myeloma Therapeutic MLN9708 provided
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MM-47 (pending 4th Qtr) Phase 1b/3 Multicenter STudy of Oprozomib, Pomalidomide, and Phase Ib/III Dexamethasone in Primary Refractory or Relapsed and Refractory Multiple Therapeutic Myeloma Subjects Oprozomib provided
MYELODYSPLASTIC SYNDROME MDS-15: MEI-005 A Phase II Simon Two-Stage Study of the Addition of Pracinostat to a Phase II Hypomethylating Agent (HMA) in Patients with Myelodysplastic Syndrome Therapeutic (MDS) Who Have Failed to Respond or Maintain a Response to the HMA Pracinostat provided Alone
MDS-16: TL32711-RAN-0094-PTL A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Phase II Azacitidine with or without Birinapant with a Single Arm Open-Label Run-In Therapeutic Phase in Subjects with Higher Risk Myelodysplastic Syndrome or Chronic Birinapant provided Myelomonocytic Leukemia
MYELOPROLIFERATIVE NEOPLASMS MPN-06: PAC326 A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Phase III Available Therapy in Patients with Thrombocytopenia and Primary Therapeutic Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Pacritinib provided Thrombocythemia Myelofibrosis
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