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
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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
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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
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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
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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)
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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
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METASTATIC, SECOND-LINE 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-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
Esophageal/Gastric Clinical Trials METASTATIC 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
METASTATIC, FIRST-LINE, HER2- GI-208: I4T-MC-JVCU A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Phase III Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapeutic Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction IMC-1121B provided Adenocarcinoma (RAINFALL)
GI-222: GS-US-296-1080 (pending 1st Qtr) A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Phase III the Efficacy and Safety of GS-5745 Combined with mFOLFOX6 as First Line Therapeutic Treatment in Patients with Advanced Gastric or Gastroesophageal Junction GS-5745 provided Adenocarcinoma
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METASTATIC, SECOND-LINE GI-201 A Phase II Study of nab-Paclitaxel plus Ramucirumab for the Second-Line Phase II Treatment of Patients with Metastatic Gastroesophageal Cancer Therapeutic Abraxane and Paclitaxel 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
GIST Clinical Trials 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
Kidney Clinical Trials ADVANCED, SECOND-LINE GU-127: CA209374 (pending 1st Qtr) A Phase 3b/4 Safety Trial of Nivolumab (BMS-936558) in Subjects with Phase IIIb/IV Advanced or Metastatic Renal Cell Carcinoma Who Have Progressed During Therapeutic or After Receiving Prior Anti-Angiogenic Therapy CheckMate 374: Nivolumab provided CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 374
REFRACTORY GU-128: C31005 (pending 1st Qtr) A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Single- Phase II Agent MLN0128 and Combination of MLN0128+MLN1117 Compared With Therapeutic Everolimus in the Treatment of Adult Patients With Advanced Clear-Cell MLN0128 and MLN1117 provided Renal Cell Carcinoma That Has Progressed on Vascular Endothelial Growth Factor-Targeted Therapy
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Liver 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
Lung – Non Small Cell Clinical Trials ADJUVANT LUN-305: D5164C00001 (pending 1st Qtr) A Phase III, Double-blind, Randomized, Placebo-Controlled Multi-center, Phase III Study to Assess the Efficacy and Safety of AZD9291 versus Placebo, in Therapeutic Patients with Epidermal Growth Factor Receptor Mutation Positive Stage AZD9291/placebo provided IB-IIIA Non-Small Cell Lung Carcinoma, following Complete Tumor Resection With or Without Adjuvant Chemotherapy (ADAURA)
LUN-308: GO29527 (pending 1st Qtr) A Phase III, Open label, Randomized Study to Investigate the Efficacy and Phase III Safety of MPDL3280A (Anti-PDL1 Antibody) Compared with Standard of Therapeutic Care Following Adjuvant Cisplatin-based Chemotherapy in PDL-1 Selected MPDL3280A provided Patients with Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer
STAGE III, UNRESECTABLE LUN-282: D4191C00001 A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-center, 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 provided Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradition Therapy (PACiFIC)
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STAGE IIIB/IV, FIRST-LINE 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
STAGE IIIB/IV, SECOND-LINE LUN-264: PPHM 1202 SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Controlled Phase III Multicenter Trial of Bavituximab Plus Docetaxel versus Docetaxel Alone in Therapeutic Patients with Previously Treated Stage IIIb/IV Non-Squamous Non Small – Bavituximab provided Cell Lung Cancer
LUN-326: CA209384 (pending 3rd qtr) A Dose Frequency Optimization, Phase IIIB/IV Trial of Nivolumab 3 mg/kg Phase IIIB/IV Every 2 Weeks vs Nivolumab 6 mg/kg Every 4 Weeks in Subjects with Therapeutic Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer Nivolumab provided who Received 4 Months of Nivolumab at 3 mg/kg Every 2 Weeks CheckMate 384: CHECKpoint Pathway and nivoluMAb clinical Trial Evaluation 384
ADVANCED, SECOND- THROUGH FOURTH-LINE LUN-214 Phase II Trial or Erlotinib and BKM120 in Patients with Advanced Non- Phase II Small-Cell Lung Cancer Previously Sensitive to Erlotinib Therapeutic BKM120 provided
METASTATIC LUN-319: CA209-370 (pending 1st Qtr) Sustain – a Phase Ii Study of Nivolumab in Maintenance or as Monotherapy Phase II or in Combination with Standard of Care Therapies in Stage IV NSCLC Therapeutic Subjects Nivolumab provided
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METASTATIC, FIRST-LINE 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 Abraxane provided with Squamous Cell Non-Small cell Lung Cancer (NSCLC)
LUN-298: GO29437 A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Phase III Efficacy and Safety of MPDL3280A (Anti-PD-L1 Antibody) in Combination Therapeutic with Carboplatin + Paclitaxel or MPDL3280A in Combination with MPDL3280A provided Carboplatin + nab-Paclitaxel Versus Carboplatin + Paclitaxel in Chemotherapy-Naïve Patients with Stage IV Squamous Non-Small Cell Lung Cancer
LUN-299: GO29537 A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Phase III Efficacy and Safety of MPDL328A (Anti-PD-L1 Antibody) in Combination Therapeutic with Carboplatin + Nab-Paclitaxel for Chemotherapy-Naïve Patients With MPDL3280A provided Stage IV Non-Squamous Non-Small Cell Lung Cancer
LUN-317: 8273-CL-0302 (pending 1st Qtr) An Open-Label, Randomized Phase 3 Efficacy Study of ASP8273 vs. Erlotinib Phase III or Gefitinib in First-Line Treatment of Patients with Stage IIIB/IV Non-small Therapeutic Cell Lung Cancer Tumors with EGFR Activating Mutations ASP8273, Erlotinib, Gefitinib provided
METASTATIC, SECOND-LINE LUN-288: I6A-MC-CBBE A Phase II Study of the Combination of LY3023414 and Necitumumab after Phase II First Line Treatment for Metastatic Squamous Non-Small Cell Carcinoma Therapeutic of the Lung LY3023414 and Necitumumab provided
METASTATIC, THIRD-LINE LUN-284: I3Y-MC-JPBK 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
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LUN-283: D4191C0004 A Phase III, Open label, Randomized, Multi-Center, 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 and Tremelimumab provided at Least Two Prior Systemic Treatment
METASTATIC, FIRST-LINE LUN-299: GO29537 A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Phase III Efficacy and Safety of MPDL3280A (Anti-PD-L1 Antibody) in Combination Therapeutic with Carboplatin + Nab-Paclitaxel for Chemotherapy-Naïve Patients with MPDL3280A provided Stage IV Non-Squamous Non-Small Cell Lung Cancer
Lung – Small Cell Clinical Trials FIRST-LINE LUN-244: 59R5-003 A Phase 1b/2 Study of OMP-59R5 in Combination with Etoposide and Phase II Cisplatin in Subjects with Untreated Extensive Stage Small Cell Lung Cancer Therapeutic also now known as PINNACLE OMP-59R5 provided
RELAPSED/REFRACTORY LUN-286: ALDOXORUBICIN-P2-SCLC-01 A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Phase IIb Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects Therapeutic with Metastatic Small Cell Lung Cancer who Either Relapsed or Were Aldoxorubicin and Topotecan provided Refractory to Prior Chemotherapy
EXTENSIVE-STAGE LUN-318: CA209-451 (pending 2nd qtr) A Randomized, Multicenter, Double Blind, Phase 3 Study of Nivolumab, Phase III Nivolumab in Combination with Ipilimumab, or Placebo in Subjects with Therapeutic Extensive-Disease Stage Small Cell lung cancer (SCLC) after Completion of Nivolumab, ipilimumab, placebo provided Platinum based First Line Chemotherapy
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Neuroendocrine GI-195 A Phase II Study of Carfilzomib for the Treatment of Patients with Phase II Advanced Neuroendocrine Cancers Therapeutic Carfilzomib provided
Ovarian Clinical Trials 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 Doxil and Trabectedin provided Tube Cancer
UNRESECTABLE GYN-52: PM1183-C-001-14 (pending 1st Qtr) Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) versus Phase III Pegylated Liposomal Doxorubicin or Topotecan in Patients with Platinum- Therapeutic Resistant Ovarian Cancer (CORAIL Trial) PM01183 provided
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 Abraxane provided
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METASTATIC, FIRST-LINE GI-220: ACE-ST-004 A Phase 2 Proof-of-Concept Study of ACP-196 in Combination with nab- Phase II Paclitaxel/Gemcitabine in Subjects with Previously Untreated Metastatic Therapeutic Pancreatic Cancer Pazopanib/placebo provided
GI-231: MM-398-07-02-03 (pending 2nd qtr) A Randomized, Open-label Phase 2 Study of Nanoliposomal Irinotecan (nal- Phase II IRI)-containing Regimens versus nab-Paclitaxel plus Gemcitabine in Therapeutic Patients with Previously Untreated, Metastatic Pancreatic Adenocarcinoma Nal-IRI, 5FU, Leucovorin/levoleucovorin, Oxaliplatin, nab-Paclitaxel and Gemcitabine 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
METASTATIC; SECOND-LINE GI-199: INCB 18424-363 (ON HOLD) A Randomized, Double-Blind, Phase 3 Study of the JAK 1/2 Inhibitor Phase III Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Therapeutic Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed Capecitabine and Ruxolitinib provided or Are Intolerant to First-Line Chemotherapy (The JANUS 2 Study)
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
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Prostate Clinical Trials METASTATIC, CASTRATION RESISTANT GU-99 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 Enzalutamide, Everolimus and RAD001 provided
GU-115: I6A-MC-CBBD A Randomized Phase II Study of Enzalutamide With or Without the PI3 Phase II Kinase/mTOR Inhibitor LY3023414 in Men with Chemotherapy Naïve Therapeutic Metastatic Prostate Cancer LY3023414 provided
Sarcoma ADVANCED/METASTATIC SARC-03: I5B-MC-JGDJ A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Phase III Doxorubicin plus Olaratumab versus Doxorubicin plus Placebo in Patients Therapeutic with Advanced or Metastatic Soft Tissue Sarcoma Olaratumab/placebo provided
Urothelial LOCALLY ADVANCED/UNRESECTABLE/METASTATIC GU-120: I4T-MC-JVDC A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Phase III Ramucirumab plus Docetaxel versus Placebo plus Docetaxel in Patients Therapeutic with Locally Advanced or Unresectable or Metastatic Transitional Cell IMC-1121B provided Carcinoma of the Urothelium who Progressed following Platinum-based Therapy
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Hematological Malignancies CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) FIRST-LINE CLL-37: ACE-CL-007 (pending 2nd qtr) A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Phase III Ublituximab in Combination with Ibrutinib Compared to Ibrutinib Alone, in Therapeutic Patients with Previously Treated High-Risk Chronic Lymphocytic Leukemia ACP-196, Obinutuzumab and Chlorambucil (CLL) provided
AT LEAST SECOND-LINE CLL-35: UTX-IB-301 A Phase 3, Randomized, Study to Assess the Efficacy and Safety of Phase III Ublituximab in Combination with Ibrutinib Compared to Ibrutinib Alone, in Therapeutic Patients with Previously Treated High-Risk Chronic Lymphocytic Leukemia Ublituximab provided (CLL)
RELAPSED/REFRACTORY 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 provided
CHRONIC MYELOGENOUS LEUKEMIA (CML) 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 BMS-354825 Imatinib
MULTIPLE MYELOMA FIRST-LINE 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 MaintenANCE in Patients with Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE)
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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
RELAPSED/REFRACTORY MM-42: MLN9708 Open-Label Study to Determine the Feasibility of MLN9708 as Maintenance Phase I/II after Allogeneic Stem Cell Transplant for Multiple Myeloma, Followed by Therapeutic an Expansion Phase at the Maximum-Tolerated Dose (MTD) MLN9708 provided
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
MM-68: ARRAY-520-001 (pending 2nd qtr) An Open-Label, Multicenter Rollover Study to Allow Continued Access to Rollover MM-45 Filanesib (ARRY-520) for Patients with Multiple Myeloma Who Are Therapeutic Currently Receiving Filanesib in Studies Sponsored by Array BioPharma, Inc. ARRY-520 provided
THIRD-LINE AND BEYOND MM-69: KCP-330-015 (pending 2nd qtr) A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Phase II Study of Selinexor (KPT-330), Carfilzomib, and Dexamethasone in Patients Therapeutic with Relapsed/Refractory Multiple Myeloma Previously Treated with a Selinexor (KPT-330)/placebo provided Proteasome Inhibitor and an Immunomodulatory Drug
SMOULDERING MM-60: 54767414SMM2001 A Randomized Phase 2 Trial to Evaluate Three Daratumumab Dose Phase II Schedules in Smoldering Multiple Myeloma Therapeutic Daratumumab provided
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MYELODYSPLASTIC SYNDROME MDS-18: 63935937MDS3001 (pending 2nd A Phase 2/3 Study to Evaluate the Activity and Safety of Imetelstat (JNJ- qtr) 63935937) in Transfusion-Dependent Subjects with Low or Intermediate-1 Phase II Risk Myelodysplastic Syndrome (MDS) who have Failed Erythropoiesis- Therapeutic Stimulating Agent (ESA) Treatment Imetelstat/placebo provided
MDS-19: SGN33A-004 (pending 2nd qtr) A Phase I/II Study of Vadastuximab talirine (SGN-CD33A) in Combination Phase I/II with Azacitidine in Patients with Previously Untreated International Therapeutic Prognostic Scoring System (IPSS) Intermediate-2 or High-Risk Vadastuximab talirine (SGN-CD33A)/placebo Myelodysplastic Syndrome (MDS) provided
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, or Post-Essential Thrombocythemia Myelofibrosis Pacritinib provided
MPN-07: 63935937MYF2001 (pending 1st A Randomized, Multicenter Phase 2 Study to Evaluate the Activity of 2 qtr) Dose Levels of Imetelstat (GRN163L) in Subjects with Intermediate-2 or Phase II Hihg-Risk Myelofibrosis (MF) Previously Treated with Janus Kinase (JAK) Therapeutic Inhibitor Imetelstat provided
MPN-08: WO29806 A Phase IB/II, Randomized, Double-Blind, Placebo-Controlled Study to Phase Ib/II Evaluate the Efficacy and Safety of Vismodegib in Combination with Therapeutic Ruxolitinib versus Placebo and Ruxolitinib in Intermediate to High Risk GDC-0449 provided Myelofibrosis
NON-HODGKIN’S LYMPHOMA-FOLLICULAR FIRST-LINE LYM-99: GS-US-313-1414 A Phase 2, Single Arm Study Evaluating the Safety and Efficacy of Idelalisib Phase II in Combination with Rituximab for Previously Untreated Indolent Non- Therapeutic Hodgkin Lymphoma Idelalisib provided
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LYM-104: GO27878 A Phase IB/II, Open-Label Study Evaluating the Safety and Phase Ib/II Pharmacokinetics of GDC-0199 (ABT-199) in Combination with Rituximab Therapeutic or Obinutuzumab plus Cyclophosphamide, Doxorubicin, Vincristine, and ABT-199, GA101 and Rituximab provided Prednisone (CHOP) in Patients with B-Cell Non-Hodgkin’s Lymphoma (NHL) and DLBCL
RELAPSED/REFRACTORY LYM-82: GO27834 A Randomized, Non-Comparative, Open-label, Multicenter, Phase II Trial Phase I Evaluation the Safety and Activity of Pinatuzumab Vedotin (DCDT2980S) in Therapeutic Combination with Rituximab and a Non-Randomized Phase Ib/II Evaluation DCDS4501A, DCDT2980S and GA101 of Polatuzumab Vedotin in Combination with Obinutuzumab in Patients provided with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma
LYM-106: CC-5013-NHL-007 A Phase 3, Double-Blind Randomized Study to Compare the Efficacy and Phase III Safety of Rituximab plus Lenalidomide (CC-5013) versus Rituximab plus Therapeutic Placebo in Subjects with Relapsed/Refractory Indolent Lymphoma Lenalidomide/placebo provided
LYM-110: MDV 9300-01 (pending 1st Qtr) An International, Phase 2, Open-Label, Efficacy and Safety Study of Phase II MDV9300 in Patients With an Incomplete Response Following Salvage Therapeutic Therapy or Autologous Stem Cell Transplantation for Relapsed or MDV9300 provided Refractory CD20+ Diffuse Large B-Cell Lymphoma
TRANSPLANT BMT-08: ACT-128800 (pending 3rd qtr) A Phase 2, Open Label, Single-Arm, Intra-patient Dose-Escalation Study Phase II with Ponesimod in Patients with Symptomatic Moderate or Severe Chronic Therapeutic GVHD Inadequately Responding to First or Second Line Therapy Ponesimod provided
BMT-10: INCB 039110-108 (pending 1st qtr) A Randomized, Parallel-Cohort Phase I Study of INCB039110 in Phase I Combination with Corticosteriods for the Treatment of Grade II-IV Acute Therapeutic Graft-Versus-Host Disease INCB039110 provided
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BMT CTN 07LT (KWD only) Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy Phase III for Patients on BMT CTN 0702 Protocol Therapeutic Lenalidomide
BMT CTN 1101 (KWD only) A Multi-Center, Phase III, Randomized Trial of Reduced Intensity (RIC) Phase III Conditioning and Transplantation of Double Unrelated Umbilical Cord Therapeutic Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow (haplo-BM) No drug provided for Patients with Hematologic Malignancies
BMT CTN 1205 (KWD only) Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Phase II Transplantation Clinical Trials Therapeutic No drug provided
CIBMTR 10-CBA (KWD only) A Multicenter Access and Distribution Protocol for Unlicensed Observational Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and No drug provided Adult Patients with Hematologic Malignancies and Other Indications
CMX001-301 (KWD only) A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Multicenter, Phase 3 Study of the Safety, Tolerability and Efficacy of Therapeutic CMX001 for the Prevention of Cytomegalovirus (CMV) Infection in CMV- CMX-001 provided seropositive (R+) Hematopoietic Stem Cell Transplant Recipients
NMDP Research Repository (KWD only) Allogenic Hematopoietic Stem Cell Transplantation and Marrow Toxic Observational Injuries/Hematopietic Cell Transplantation, Other Cellular Therapies and No drug provided Marrow Toxic Injuries
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