All Studies by Indication

Transcription

1 Therapeutic Area Protocol Number Drug/Device Phase Description Advanced malignancies AMG 337 I " A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AMG 336 in Adult Subjects with Advanced Solid Tumors." Advanced malignancies CUDC CUDC-101 Other "A Phase 1b open-label, expansion study to invetigate the safety, efficacy, and pharmacokinetics of intravenous CUCD-101 in subjects with advanced head and neck, gastric breast, and liver tumors" Advanced malignancies E6201-A E6201 I "A Phase 1, Multicenter, Open- Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of E6201 in Subjects with Advanced Solid Tumors (Revised per Amendment 03)" Advanced malignancies BRF GSK I "A Phase I, Open-Label, Multiple-Dose, Dose- Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of the BRAF Inhibitor GSK in Subjects with Solid Tumors" Advanced malignancies EGF Lapatinib Other "Open Label, phase 1b continuation study of lapatinib monotherapy or lapatinib in combination with other anticancer treatment un patients with solid tumors." Advanced malignancies EGF Other "open label, randomized, adaptive design, two-period crossover study in cancer patients to evaluate the bioequivalence of alternative formulations of lapatinib compared to the commercial tablet." Advanced malignancies MDX (BMS 1203) MDX 1105 I " A Phase 1, Open-label, Multicenter, Dose-escalation, Multidose Study of MDX-1105 Administered Every 14 Days in Subjects with Selected Advanced or Recurrent Solid Tumors"

2 Basal cell SHH4811G GDC-0449 Other "A Single-Aem, Open-Label, Expanded Access Study of GDC-0449 In Patients With Locally Advanced Or Metastatic Basal Cell Carcinoma" Basal cell SHH4476g GDC-0449 II A Pivotal Phase II, multicenter, single-arm, two-cohort trial evaluating the efficacy and safety of GDC-0449 in patients with advanced basal cell carcinoma Breast Cancer Denosumab III "A Randomized Double-Blind, Placebo-Controlled, Multi- Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at Hight Risk of Recurrence Breast Cancer CDX CDX011 II "A Phase II, Randomized, Multicenter Study of CDX011 (CR011-vcMMAE) in Patients with Advanced GPNMBexpressing Breast Cancer." Breast Cancer TDM4370G Trastuzumab-MCC-DM1 vs. Capecitabine+Lapatinib III "A Randomized, Multicenter, Phase III Open-Label Study Of The Efficacy And Safety Of Trastuzumab-MCC-DM1 vs. Capecitabine+Lapatinib In Patients With Her2-Positive Locally Advanced Or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy" Breast Cancer RAD001Y2301 RAD001 (Everolimus) III "A Randomized double-blind, Placebo-cotrolled Study of Everolimus in Combination with Exemestane in the Treatment of Postmenopausal Women with Estrogen Receptor Positive, Locally Advanced or Metastatic Breast Cancer who are refractory to Letrozole or Anastrozole"

3 Melanoma M ABT-888 II "A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating the Efficacy of ABT-888 in Combination with Temozolomide Versus Temozolomide Alone in Subjects wit Metastatic Melanoma 155-CL-034 YM155 II "A Phase II, Multicenter, Open- Label Study Of YM 155 Plus Docetaxel in Subjects with Stage III (Unresectable) or Stage IV Melanoma ATN ATN-224 II A Randomized Phase II trial of AT224 in Combination with Temozolomide or Temozolomide Followed by ATN-224 in Systemictreatment Naive Patients with Advanced Melanoma Melanoma AVF3773s/ABX055 Abraxane/Avastin II Abraxane and Avastin as Therapy for Patients with Malignant Melanoma, a Phase II Study Melanoma CA184029/EORTC protocol Ipilimumab III Adjuvant immunotherapy with anti-ctla-4 monoclonal antibody (Ipilimumab) versus placebo after complete resection of high-risk Stage III Melanoma: A randomized, double-blind Phase 3 trial of the EORTC Melanoma Group Melanoma CA Ipilimumab III A Multicenter Treatment Protocol for compassionate use of Imilimumab(BMS ) Monotherapy in Subjects with Unresectable Stage III or Stage IV Melanoma Melanoma CA Ipilimumab A Randomized, Parallel, 3- Arm Study to Characterize the Effect of Ipilimumab on the Pharmacokinetics of Chemotherapy and the Effect of Chemotherapy on the Pharmacokinetics in Subjects with Untreated Advanced Melanoma Melanoma BMS CA Ipilimumab BMS "A Randomized, Parallel, Open-Label Study to Compare the Pharmakokinetics of Ipilimumab (BMS ) Process C to Process B in Subjects with Advanced

4 Melanoma CA MDX-010 II A Multi-Center, Open-Label, Phase II Study of Impilimumab (MDX-010) Extended- Treatment Monotherapy or Follow Up for Patients Previously Enrolled in Ipilimumab(MDX-010) Protocols Melanoma E7080-G E7080 II "An Open-Label, 2-Cohort, Multicenter, Phase 2 Study of E7080 in Previously Treated Subjects With Unresectable Stage III of Stage IV Melanoma." Melanoma E ONTAK II "A Phase II Open_label, Multicenter Study of ONTAK in Patients with Stage IIIC and IV Melanoma ML25597 RO Other "A Single-arm, Open-label, Expanded Access Study of RO in Patients with Metastatic Melanoma GSK GSK GSK I "An Open-Label, Dose- Escalation, Phase I Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the BRAF Inhibitor GSK in Combination with MEK Inhibitor GSK in Subjects with BRAF Mutant Metastatic Melanoma BRF113220" Melanoma BRF GSK II " A Phase II (BRF113710) single-arm, open-label study of GSK in previously treated BRAF mutant metastatic melanoma BRF113710" Melanoma MAGE-A3 + AS 15 ASCI III "A double-blind, randomized, placebo-controlled Phase III study to assess the efficacy of recmage-a3 + AS15 ASCI as adjuvant therapy in patients with MAGE-A3 positive resected stage III melanoma." Melanoma recmage-a3+as15 I "An open, single-arm trial to assess the clinical activity of recmage-a3+as15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma."

5 Melanoma RTS-M101B' INXN-3001 Other "Phase 1b' Open Labe, Single Arm, Multicenter Trial to Evaluate the Safety, Tolerance, Response RAte and Immunological Effect of Repeated Intratumoral Injections of Adenoviral Transduced Autologus Dendridic Cells Engineering to Express hil-12(inxn-3001) in response to an Oral Activator Ligand Administered in Intra- Patient Escalating Doses in Patients with Unresectable Stage III Cor IV Malignant Melanoma." Melanoma H8K-MC-JZAO Tasisulam III "A Randomized Phase 3 Study of Tasisulam Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle vs. Paclitaxel as Second-Line Treatment in Patients with Metastatic Melanoma." Melanoma H8K-MC-JZAF LY II "A Phase 2 Study of LY Administered as an Intravenous Infusion on Day 1 of a 21-Day Cycle as SEcond Line Treatment in Patients with Unresectable or Metastatic Melanoma MKC1106-MT-002 MKC1106-MT II "A Phase 2, Open Label, Non- Randomized Study to Evaluate the Safety, Tolerability, Immune Response and Clinical Response pf Multiple Doses of MKC1106-MT in Subjects with Advanced Melanoma C15005 MLN4924 I "A Phase 1, Open Label, Dose Escalation Study of MLN4924, A Novel Inhibitor of Nedd8 Activating Enzyme, in Adult Patients with Melanoma NO25026 RO III "A Randomized, Open-label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma with V600E BRAF Mutation Receiving RO or Dacarbazine"

6 Melanoma IND.202 IL-21 II "A RANDOMIZED PHASE II STUDY OF INTERLEUKIN-21 (ril-21) VERSUS DACARBAZINE (DTIC) IN PATIENTS WITH METASTATIC OR RECURRENT MELANOMA: Prostate Cancer AMG AMG 745 A Randomized, Double-Blind, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Multiple Doses of AMG 745 in Men With Prostate Cancer Receiving Androgen Deprivation Therapy, dated August 3, 2006 Prostate Cancer CC-5013-PC-002 Docetaxel and Prednisone w/wo Lenalidomide III "A Phase 3 Study to Evaluate the Efficacy and Safety of Decetaxel and Prednisone with or without Lenalidomide in Subjects with Castrate- Resistant Prostate Cancer" Prostate Cancer COU-AA-301 Abiraterone Acetate (CB7630) III A Phase 3, Randomized, Double-blind, Placebo- Controlled Study of Abiraterone Acetate(CB7630) Plus Prednisone in Patients with Metastatic Castration- Resistant Prostate Cancer Who Have Failed Docetaxal- Based Chemotherapy Prostate Cancer COU-AA-302 Abitarone Acetate (CB7630) III "A Phase 3, Randomized, Bouble-Blind, Placebo- Controlled Study of Abitarone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients with Metastatic Castration- Resistant Prostate Cancer Prostate Cancer TAK TAK-700 I / II "A Phase 1/2, Open-Label, Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of TAK-700 in Metastatic, Androgen- Independent Prostate Cancer Subjects."

7 Prostate Cancer C21004 Orteronel (TAK-700) Plus Prednisone III "A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK- 700) Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy- Naive Metastatic Castration- Resistant Prostate Cancer" Prostate Cancer C21005 Orteronel (TAK-700) plus Prednisone III "A Phase 3, Rnadomized, Double-Blind, Multicenter Trial Comparig Orteronel (TAK-700) Plus Prednisone with Placebo Plus Prednisone in Patients With Metastatic Castration- Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy"