Molecular Profiling METASTATIC, REFRACTORY, HER2+, BREAST PHASE 1, METASTATIC, RELAPSED/REFRACTORY, PROSTATE OVARIAN
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1 FOR MORE INFORMATION OR TO REFER A PATIENT TO ANY OF OUR CLINICAL TRIALS PLEASE CONTACT NICOLE GIVEN, BS, OHC RESEARCH DEPARTEMTN AT , EXT Phase 1 REFMAL 381 (Phase 1 open at BAM only) Phase I Nivolumab and abraxane provided METASTATIC, REFRACTORY, HER2+, BREAST BRE- 200 (Phase 1 open at BAM only) Cabazitaxel/Lapatinib provided PHASE 1, METASTATIC, RELAPSED/REFRACTORY, PROSTATE A Phase 1, Open- Label, Multicenter, Safety Study of Nivolumab (BMS ) in Combination with nab- Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, nab- Paclitaxel/Carboplatin in Stage IIIB/IV Non- Small Cell Lung Cancer or nab- Paclitaxel in Recurrent Metastatic Breast Cancer A Study with Lead- In Safety Cohort of Cabazitaxel plus Lapatinib as Therapy for HER2- Positive Metastatic Breast Cancer Patients with Intracranial Metastases GU- 99: LOI GU Phase I Everolimus, Enzalutamide provided Enzalutamide plus Everolimus in Men with Metastatic Castrate- Resistant Prostate Cancer and Previous Treatment with Docetaxel: A Phase I Study with a Maximum Tolerated Dose Expansion Cohort OVARIAN REFMAL- 226: X82- CLI- 101 (BAM only; ON HOLD) Phase I X- 82 provided A Phase I, First in Human Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of X- 82 in Subjects with Advanced Solid Tumors Molecular Profiling PRO- 02: ML28897 A Trastuzumab, Pertuzumab, Erlotinib, Vemurafenib, Vismodegib provided MY PATHWAY: An Open- Label A Study Evaluating Trastuzumab/ Pertuzumab, Erlotinib, Vemurafenib, and Vismodegib in Patients who Have Advanced Solid Tumors with Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents Page 1 of 15
2 PRO- 11: CBGJ398XUS04 (pending) BGJ398 provided PRO- 12: CLDK378AUS23 (pending) Ceritinib provided PRO- 13: CLEE011XUS03 (pending) LEE011 provided Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 6 BGJ398 for patients with tumors with FGFR genetic alterations Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 7 Ceritinib (LDK378) for patients whose tumors have aberrations in ALK or ROS1 Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 8 LEE011 for patients with CDK4/6, Cyclin D1/3 or p16 activated tumors Bladder Clinical Trials GU- 113: GO29293 ( Cohort 2 CLOSED) MPDL3280A provided A, Multicenter, Single- Arm Study of MPDL3280A in Patients with Locally Advanced or Metastatic Urothelial Bladder Cancer Brain Clinical Trials SECOND- LINE CNS- 22: STML (pending 1 st Qtr) Phase I/II SL- 701, Montanide emulsion, imiquimod topical cream 5%, GM- CSF provided A Phase ½ Study of SL- 701, a Subcutaneously Injected Multivalent Gilioma- Associated Antigen Vaccine, in Adult Patients with Recurrent Glioblastoma Multiforme Page 2 of 15
3 Breast Clinical Trials ADJUVANT, HER2+ BRE- 186 (Cohort A & B closed) Eribulin provided BRE- 233: BO28407 I TDM- 1 provided NEOADJUVANT, TNBC BRE- 238: M I Veliparib/Carboplatin provided FIRST- LINE, HR+, HER2- BRE- 234: CLEE011A2301 I LEE011 provided METASTATIC, FIRST- LINE, HER2- BRE- 252: LEE011E2301 (pending 2 nd qtr) I LEE011/placebo provided Phase 2 Trial of Eribulin in Patients Who do Not Achieve Pathologic Complete Response (pcr) Following Neoadjuvant Chemotherapy A Randomized, Multicenter, Open- Label Trial Comparing Chemotherapy plus Trastuzumab plus Pertuzumab versus Chemotherapy plus Trastuzumab Emtansine plus Pertuzumab as Adjuvant Therapy in Patients with Operable HER2- Positive Primary Breast Cancer A Randomized, Placebo- Controlled, Double- Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects with Early Stage Triple Negative Breast Cancer (TNBC) A Randomized, Double- Blind, Placebo- Controlled Study of LEE011 in Combination with Letrozole for the Treatment of Postmenopausal Women with Hormone Receptor Positive, HER2- Negative, Advanced Breast Cancer who Received no Prior Therapy for Advanced Disease A I randomized, double- blind, placebo- controlled study of LEE011 or placebo in combination with tamoxifen and goserelin or a non- steroidal aromatase inhibitor (NSAI) and goserelin for the treatment of premenopausal women with hormone receptor positive, HER2- negative, advanced breast cancer Page 3 of 15
4 METASTATIC, FIRST- LINE, TNBC BRE- 223: ABI MBC- 001 /III Nab- Paclitaxel provided BRE- 231: CDX CDX- 011 provided BRE- 242: INCB Ruxolitinib/placebo provided Phase 2/3, Multi- center, Open- Label, Randomized Study of Weekly Nab- Paclitaxel (ABRAXANE) in Combination with Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First- Line Treatment in Subjects with ER, PgR, and HER2 Negative (Triple Negative) Metastatic Breast Cancer A Randomized Multicenter Study of CDX- 011 (CR011- vcmmae) in Patients with Metastatic, GPNMB Over- Expressing, Triple- Negative Breast Cancer A Randomized, Double- Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination with Capecitabine in Subjects With Advanced or Metastatic HER2- Negative Breast Cancer METASTATIC, SECOND- LINE, HER2+ BRE- 249: MM (pending 1 st qtr) MM- 302 provided METASTATIC, REFRACTORY, ER/PR POSITIVE BRE- 229: MDV Enzalutamide/placebo & Exemestane provided A Randomized, Multicenter, Open Label Study of MM- 302 plus Trastuzumab vs. Chemotherapy of Physician s Choice plus Trastuzumab in Anthracycline Naïve Patients with Locally Advanced/Metastatic HER2- Positive Breast Cancer A Phase 2, Randomized, Double- Blind, Placebo- Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination with Exemestane in Patients with Advanced Breast Cancer That is Estrogen or Progesterone Receptor- Positive and HER2- Normal BRE- 242: INCB Ruxolitinib/placebo provided A Randomized, Double- Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination with Capecitabine in Subjects With Advanced or Metastatic HER2- Negative Breast Cancer Page 4 of 15
5 METASTATIC, REFRACTORY, HER2+ BRE- 200 (Phase 1 open at BAM only) Cabazitaxel/Lapatinib provided BRE- 240: CL Enzalutamide provided METASTATIC, REFRACTORY, TNBC BRE- 231: CDX CDX- 011 provided BRE- 242: INCB Ruxolitinib/placebo provided SECOND- LINE, HER2-, HR+ BRE- 241: I3Y- MC- JPBN LY provided A Study with Lead- In Safety Cohort of Cabazitaxel plus Lapatinib as Therapy for HER2- Positive Metastatic Breast Cancer Patients with Intracranial Metastases Phase 2, Multicenter, Open- Label Study to Assess the Efficacy and Safety of Enzalutamide with Trastuzumab in Subjects with HER2+ AR+ Metastatic or Locally Advanced Breast Cancer A Randomized Multicenter Study of CDX- 011 (CR011- vcmmae) in Patients with Metastatic, GPNMB Over- Expressing, Triple Negative Breast Cancer A Randomized, Double- Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination with Capecitabine in Subjects With Advanced or Metastatic HER2- Negative Breast Cancer A Phase 2 Study of LY for Patients with Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer Colorectal/Rectal Clinical Trials METASTATIC, FIRST- LINE GI- 200: BP29262 RO , Bevacizumab provided A, Multicenter, Randomized, Double- Blind Study to Evaluate the Efficacy and Safety of RO Plus FOLFOX Versus Bevacizumab Plus FOLFOX in Patients with Previously Untreated Metastatic Colorectal Cancer Page 5 of 15
6 METASTATIC, REFRACTORY GI- 190: PT023 (ON HOLD) I MABp1 provided METASTATIC, SECOND- LINE GI- 198: INCB I Ruxolitinib/placebo provided A Pivotal I Study to Evaluate Overall Survival using MABp1 as a Monotherapy in Metastatic Colorectal Cancer Patients with Cachexia A Randomized, Double- Blind Study of Ruxolitinib or Placebo in Combination with Regorafenib in Subjects with Relapsed or Refractory Metastatic Colorectal Cancer Esophageal/Gastric Clinical Trials NEOADJUVANT GI- 166 Lapatinib provided A Study with Lead- in Safety Cohort of 5- Fluorouracil, Oxaliplatin and Lapatinib in Combination with Radiation Therapy as Neoadjuvant Treatment for Patients with Localized HER2 Positive Esophagogastric Adenocarcinoma METASTATIC, FIRST- LINE GI- 185: BO25114 I Pertuzumab/placebo, Trastuzumab provided GI- 208: I4T- MC- JVCU (pending 2 nd qtr) I Ramucirumab/placebo provided A Double- Blind, Placebo- Controlled, Randomized, Multicenter I Study Evaluating the Efficacy and Safety of Pertuzumab in Combination with Trastuzumab and Chemotherapy in Patients with HER2- Positive Metastatic Gastroesophageal Junction and Gastric Cancer A Randomized, Double- Blind, Placebo- Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First- line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL) Page 6 of 15
7 METASTATIC, SECOND- LINE GI- 202: C26002 MLN0264 provided A Phase 2 Trial of MLN0264 in Previously Treated Patients with Metastatic or Recurrent Adenocarcinoma of the Stomach or Gastroesophageal Junction Expressing Guanylyl cyclase (GCC) Kidney Clinical Trials METASTATIC, FIRST- LINE GU- 108: WO29074 MPDL3280A provided A, Randomized Study of MPDL2380A Administered as Monotherapy or in Combination with Bevacizumab versus Sunitinib in Patients with Untreated Advanced Renal Cell Carcinoma Lung Non Small Cell Clinical Trials STAGE IIIB/IV, FIRST- LINE LUN- 229 OGX- 427 provided Double- Blind Randomized Trial of Carboplatin and Pemetrexed with or without OGX- 427 in Patients with Previously Untreated Stage IV Non- Squamous Non- Small Cell Lung Cancer (Spruce Clinical Trials) LUN- 261: D6011C00002 (ON HOLD) AZD1775 provided LUN- 263: ABI NSCL- 003 I Nab- Paclitaxel provided Double- Blind Randomized Trial of Carboplatin and Pemetrexed with or without AZD1775 in Patients with Previously Untreated Stage IV Non- Squamous Non- Small- Cell Lung Cancer A I, Randomized, Open- Label, Crossover, Multi- Center, Safety and Efficacy Study to Evaluate Nab- Paclitaxel (ABRAXANE) as Maintenance Treatment After Induction with Nab- Paclitaxel Plus Carboplatin in Subjects with Squamous Cell Non- Small Cell Lung Cancer (NSCLC) Page 7 of 15
8 STAGE IIIB/IV, SECOND- LINE LUN- 291: EMR (pending 2 nd Qtr) I MSB C provided STAGE IIIB/IV, THIRD- LINE LUN- 283: D4191C0004 (pending 1 st Qtr) I MEDI4736 provided A I open- label, multicenter trial of MSB C versus docetaxel in subjects with PD- L1 positive non- small cell lung cancer that has progressed after a platinum- containing doublet A I, Open label, Randomised, Multi- centre, International Study of MEDI4736 versus Standard of Care in Patients with Locally Advanced or Metastatic Non- Small Cell Lung Cancer (Stage IIIB- IV) Who Have Received 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 I MEDI4736 RELAPSED/REFRACTORY LUN- 214 BKM120 provided LUN- 238: AT AT13387 LUN- 262: D6011C00001 (ON HOLD) AZD1175 provided A I, Randomised, Double- blind, Placebo- controlled, Multi- centre, International Study of MEDI4736 as Sequential Therapy in Patients with Locally Advanced, Unresectable Non- Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum- Based, Concurrent Chemoradiation Therapy (PACIFIC) Trial of Erlotinib and BMK120 in Patients with Advanced Non- Small- Cell Lung Cancer Previously Sensitive to Erlotinib A Study of HSP90 Inhibitor AT13387 Alone and in Combination with Crizotinib in the Treatment of Non- Small Cell Lung Cancer (NSCLC) A Lead- in Multicentre, Randomized, Double- Blind Study Comparing AZD1175 plus Docetaxel and Placebo plus Docetaxel in Previously Treated Patients with p53 Non- Small- Cell Lung Cancer Page 8 of 15
9 LUN- 264: PPHM 1202 I Bavituximab provided LUN- 270: D4191C00003 MEDI4736 provided LUN- 284: I3Y- MC- JPBK I LY provided Lung Small Cell Clinical Trials EXTENSIVE STAGE, FIRST- LINE LUN- 244: 59R5-003 (pending 1 st qtr) Phase 1b/2 OMP- 59R5/placebo provided SUNRISE: A I, Randomized, Double- Blind, Placebo- Controlled Multicenter Trial of Bavituximab Plus Docetaxel versus Docetaxel Alone as Second- Line Therapy in Patients with Stage IIIB/IV Non- Squamous Non Small- Cell Lung Cancer A, Non- comparative, Open label, Multi- centre, International Study of MEDI4736, in Patients with Locally Advanced or Metastatic Non- Small Cell Lung Cancer who have Received at Least Two Prior Systemic Treatment Regimens including One Platinum- based Chemotherapy Regimen (ATLANTIC) A Randomized Phase 3 Study of LY versus Erlotinib in Patients with Stage IV NSCLC with a detectable KRAS mutation who have progressed after platinum- based chemotherapy A Phase 1b/2 Study of OMP- 59R5 in Combination with Etoposide and Cisplatin in Subjects with Untreated Extensive Stage Small Cell Lung Cancer also now known as PINNACLE RTOG 0937 Randomized Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra- Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED- SCLC) RELAPSED/REFRACTORY, SECOND- LINE LUN- 286: ALDOXORUBICIN- P2- SCLC- 01 (pending 2 ndt Qtr) Phase 2b Aldoxorubicin and topotecan required A Multicenter, Randomized, Open- Label Phase 2b Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects with Metastatic Small Cell Lung Cancer Who Either Relapsed or Were Refractory to Prior Chemotherapy Page 9 of 15
10 Ovarian Clinical Trials PHASE 1 REFMAL- 226: X82- CLI- 101 (BAM only; ON HOLD) Phase I X- 82 provided THIRD- LINE GYN- 41: ET743- OVC I Yondelis provided A Phase I, First in Human Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of X- 82 in Subjects with Advanced Solid Tumors A Randomized, Open- Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced- Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Pancreas Clinical Trials ADJUVANT GI- 194: ABI PANC- 003 I Nab- Paclitaxel provided FIRST- LINE GI- 183: 59R5-002 OMP- 59R5 provided A Phase 3, Multicenter, Open- Label, Randomized Study of nab- Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects with Surgically Resected Pancreatic Adenocarcinoma A Phase 1b/2 Study of OMP- 59R5 in Combination with Nab- Paclitaxel and Gemcitabine in Subjects with Previously Untreated Stage IV Pancreatic Cancer ALPINE: Antibody therapy in first- Line Pancreatic cancer Investigating anti- Notch Efficacy and safety Page 10 of 15
11 SECOND- LINE GI- 199: INCB I Ruxolitinib/placebo provided GI- 203: C26003 MLN0264 provided A Randomized, Double- Blinded Trial of Gemcitabine Plus Nab- Paclitaxel Combined with OGX- 427 or Placebo in Patients With Metastatic Pancreatic Cancer (The Rainier Trial) A Phase 2 Trial of MLN0264 in Previously Treated Patients with Advanced or Metastatic Pancreatic Adenocarcinoma Expressing Guanylyl Cyclase C (GCC) Prostate Clinical Trials PHASE 1, METASTATIC, RELAPSED/REFRACTORY GU- 99: LOI GU Phase I Everolimus, Enzalutamide provided Enzalutamide plus Everolimus in Men with Metastatic Castrate- Resistant Prostate Cancer and Previous Treatment with Docetaxel: A Phase I Study with a Maximum Tolerated Dose Expansion Cohort Radiation Clinical Trials ED - SCLC RTOG 0937 Randomized Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra- Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED- SCLC) Page 11 of 15
12 Hematological Malignancies LYM- 89: GS- US GS A Phase 2 Open Label, Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacodynamics of GS in Patients with Relapsed or Refractory Hematologic Malignancies CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) FIRST- LINE CLL- 32: GS- US (ON HOLD) I IDELA/placebo provided A Phase 3, Randomized, Double- Blind, Placebo- Controlled Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia CLL- 34: PCYC CA (pending 2 nd Qtr) I Ibrutinib, chlorambucil, and obinutuzumab provided A Randomized, Multicenter, Open- label, Phase 3 Study of the Bruton s Tyrosine Kinase Inhibitor Ibrutinib in Combination with Obinutuzumab versus Chlorambucil in Combination with Obinutuzumab in Subject s with Treatment- Naïve Chronic Lymphocythic Leukemia or Small Lymphocytic Lymphoma Relapsed/Refractory CLL- 18: LOI CLL Ofatumumab CLL- 30: IPI I IPI- 145, Ofatumumab provided CLL- 31: IPI Rollover IPI- 145, Ofatumumab provided Trial: Rapid infusion of Ofatumumab in Patients with Previously Treated CLL A Phase 3 Study of IPI- 145 versus Ofatumumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma A Study of IPI- 145 and Ofatumumab in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Previously Enrolled in Study IPI (CLL- 30 Rollover Study) Page 12 of 15
13 SECOND- LINE CLL- 35: UTX- IB- 301 (pending 2 nd Qtr) I Ublituximab provided A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination with Ibrutinib Compared to Ibrutinib Alone, in Patients with Previously Treated High- Risk Chronic Lymphocytic Leukemia (CLL) CHRONIC MYELOGENOUS LEUKEMIA (CML) SECOND- LINE CML- 18: CA Phase IV Dasatinib provided An Open Label, Randomized Phase IV Study of Dasatinib vs. Imatinib in the Treatment of Subjects with Chronic Phase Chronic Myeloid Leukemia who Have not Optimally Responded to 3 Months of Therapy with 400 mg Imatinib HODGKINS DISEASE FIRST- LINE LYM- 84: C25003 I Brentuximab vedotin provided A Randomized, Open- label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients with Advanced Classical Hodgkin Lymphoma NON- HODGKIN S LYMPHOMA- FOLLICULAR FIRST- LINE LYM- 99: GS- US (pending 2 nd Qtr) Idelalisib provided A Phase 2, Single Arm Study Evaluating the Safety and Efficacy of Idelalisib in Combination with Rituximab for Previously Untreated Indolent Non- Hodgkin Lymphoma RELAPSED/REFRACTORY LYM- 87: IPI IPI- 145 provided A Phase 2 Study of IPI- 145 in Subjects with Refractory Indolent NHL Page 13 of 15
14 MULTIPLE MYELOMA MM- 56: CFZ013 (pending 1 st Qtr) Phase Ib Carfilzomib provided FIRST LINE E1A11 I Carfilzomib provided MM- 58: MMY3008 (pending 2 nd Qtr) I Daratumumab provided RELAPSED/REFRACTORY MM- 42: LOI BMT Phase I/II MLN9708 provided MM- 47 (pending 4 th Qtr) Phase Ib/III Oprozomib provided Phase 1b Study of Carfilzomib Administered Once Weekly in Combination with Lenalidomide and Dexamethasone in Subjects with Multiple Myeloma E1A11, Randomized I Trial of Bortezomib, LENalidomide and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Followed by Limited or Indefinite DURation Lenalidomide MaintanANCE in Patients with Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE) Principal A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Previously Untreated Multiple Myeloma who are Ineligible for High Dose Therapy A Phase I/II study evaluating maintenance MLN9708 following an allogeneic transplant for multiple myeloma Phase 1b/3 Multicenter STudy of Oprozomib, Pomalidomide, and Dexamethasone in Primary Refractory or Relapsed and Refractory Multiple Myeloma Subjects MYELODYSPLASTIC SYNDROME MDS- 16: TL RAN PTL Birinapant provided A Phase 2, Randomized, Double- Blind, Placebo- Controlled Study of Azacitidine with or without Birinapant with a Single Arm Open- Label Run- In Phase in Subjects with Higher Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia Page 14 of 15
15 MYELOPROLIFERATIVE NEOPLASMS MPN- 06: PAC326 I Pacritinib provided A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post- Polycythemia Vera Myelofibrosis, or Post- Essential Thrombocythemia Myelofibrosis Page 15 of 15
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