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ITOR Clinical Research Unit Archived Trials

A phase I/Ib, multi-center, open-label study of BEZ235, administered orally on a continuous daily dosing schedule in adult patients with advanced solid malignancies including patients with advanced breast cancer Over 100 clinical trials have been conducted in the ITOR Clinical Research Unit (CRU) since opening in late 2004.

These trials range from live viral gene therapies, and autologous tumor vaccines, to drugs employing new mechanisms of actions.

ITOR CRU Archived trials are listed below:
Note: Please contact us for questions and additional information.

Solid Tumors

  • An Open-Label, Phase I/IB Dose Escalation Study to Assess the Safety and Tolerability of GSK1120212 in combination with Docetaxel, Erlotinib, Premetrexed, Pemetrexed + Carboplain, or nab-Paclitaxel in Subjects with Advanced Solid Tumors
  • A Phase 1b Open-Label Study of the Safety and Clinical Activity of Crizotinib (PF-02341066) in Tumors With Genetic Events Involving the Anaplastic Lymphoma Kinase (ALK) Gene Locus
  • An Open Label, Phase I Study to Evaluate Safety and PK of Praletrexate in Relaplsed/Refractory Advanced Solid Tumor or Advanced Lymphoma/Myeloma Patients with Mild, Moderate, and Severe Renal Impairment
  • A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous XMT-1001 in Patients with Advanced Solid Tumors
  • A phase I, mulitcenter, open-label, dose-escalation study of LY2812176 given IV weekly in patients with multiple myeloma or advanced solid tumors
  • A phase I/Ib, multi-center, open-label study of BEZ235, administered orally on a continuous daily dosing schedule in adult patients with advanced solid malignancies including patients with advanced breast cancer
  • A Phase 1b Study of LY573636-sodium in Combination with Sunitinib Malate in Patients with Metastatic Renal Cell Cancer (Protocol H8K-MC-JZAI)
  • A Phase Ib, Open-Label, Multi-Center, Dose Escalation and Expansion Study of an Orally Administered Combination of BKM120 Plus MEK162 in Adult Patients with Selected Advanced Solid Tumors
  • An Open-label Study to Evaluate the Effects of Ketoconazole and the Effects of Nexium on the Pharmacokinetics of Orally Administered Repeat Doses of Pazopanib in Patients with Solid Tumor Malignancies
  • Dose Escalation Study of LY573636-sodium in Combination with 1) Gemcitabine, 2) Docetaxel 3) Temozolamide for Patients with Advanced Solid Tumors
  • A Randomized, Blinded, Placebo-controlled, Two Phase, Sequential Cohort, Dose Finding Study to Assess the Safety and Efficacy of an Oral Thrombopoietin Receptor Agonist, Eltrombopag (SB-497115-GR), Administered to Patients with Solid Tumors Receiving Gemzar Monotherapy or Gemzar + Carboplatin or Cisplatin Chemotherapy
  • A Randomized discontinuation Study of XL184 in Subjects with Advanced Solid Tumors
  • An Open-Label, Clinical Trial Evaluating the Safety and Pharmacokinetics of Two Dose Schedules of Panitumumab in Subjects with Advanced Solid Tumors
  • An Open-Label, Randomized, Phase 1b Study Evaluating the Effect of Different Doses of AMG 706 on the Gallbladder in Subjects with Advanced Solid Tumors
  • An Open-Label, Dose-Finding Study to Evaluate the Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Subjects with Advanced Cancer
  • An Open-label Phase I Study of the Safety of Perifosine in Combination with Sorafenib for Patients with Advanced Cancers
  • A Phase I Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Effect of Repeat Oral Doses of Pazopanib (GW786034) on Cardiac Conduction in Subjects with Solid Tumors
  • A Phase I Dose Escalation Study of JX-594 (Thymidine Kinase-deleted Vaccinia Virus plus GM-CSF) Administered by Intravenous Infusion in Patients with Refractory Solid Tumors: **Gene Transfer Trial**
  • A Pilot Study Utilizing Molecular Profiling of Patients' Tumors to Find Potential Targets and Select Treatments for Their Refractory Cancers
  • Phase I Multi Center, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of NU206 when Administered Prior to Chemotherapy in Oncology Subjects
  • An Open-label Phase I Study of the Safety of Perifosine in Combination with Sorafenib for Patients with Advanced Cancers
  • Phase 1, Multicenter, Open-Label Dose Escalation Study Evaluating the Safety and Tolerability of Multiple AF37702 Injections in Subjects With Refractory Non-Small Cell Lung Cancer, Breast Cancer, or Prostate Cancer Who are Anemic and Receiving Cytotoxic Chemotherapy
  • A Phase I Open-Label, Dose-Escalation Study of Para-toluensulfonamide Injection (PTS) Administered Intratumorally And Locally to Patients with Solid Tumors
  • A Phase IIA Trial of Two Schedules of Perifosine in Patients for Whom No Standard Therapy Exists
  • Safety, Tolerability and Pharmacokinetic Assessment of CG53135 Administered Intravenously In Patients with Advanced (Stage 4) Colorectal, Esophageal, Gastric, or Pancreatic Cancer (Single Rising-Dose Tolerance): *First in Man Trial*
  • A Phase IIA Trial of Two Schedules of Perifosine in Patients for Whom No Standard Therapy Exists
  • A Randomized Placebo Controlled Study of Perifosine in Combination with Single agent Chemotherapy for Second line Metastatic Cancer Patients
  • A Phase I, Open-Label, Multicenter, Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administration Twice Weekly in Adult Patients with Advance Solid Malignancies Including Lymphomas without Bone Marrow Involvement: *First in Man Trial*
  • A Phase I Dose-Escalation Study of Seneca Valley Virus (SV-001), a Replication-Component Picornavirus, in Patients with Solid Tumors with Neuroendocrine Features: *First in Man trial*
  • A Pharmacokinetic Study of Hemoharringtonine (Omacetaxine Mepesuccinate) Administered Subcutaneously to Patients with Advanced Solid and Hematologic Tumors
  • A Phase I, Multicenter, Dose-Escalation Study to Determine the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), Safety, and Pharmacokinetics of Brostallicin when Used in Combination with each of the following 1) Bevacizumab, 2) Irinotecan and 3) Doxil in Patients with Advanced Solid Tumors
  • A Phase I Open Label, Multicenter, Dose-Escalation Study to Determine the Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT), Safety and Pharmacokinetics of CGC-11047 when Used in Individual Combination with Cisplatin in Patients with Advanced Solid Tumors or Lymphoma
  • A Phase I Open Label Food Effect Study to Examine the Effects of Low-fat and High-fat Meals on the Pk's of Orally Administered Lapatinib
  • A Phase I Study of the Poly (ADP-Ribose) Polymerase Inhibitor E7016 in Combination with Temozolomide in Subjects with Melanoma or Other Advanced Solid Tumors: *First in Man trial*
  • A Phase 1 and Pharmacologic Study of MM-111 in Combination with Multiple Treatment Regimens in Patients with Advanced Her2 Positive Solid Tumors
  • A Phase I Study of CC-486 as a Single Agent and in Combination with Carboplatin or ABI-007 in Subjects with Relapsed or Refractory Solid Tumors
  • A Phase I Clinical Study of BBI503 in Adult Patients with Advanced Solid Tumors
  • A Phase I, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmadynamics of AMG 820 in Adult Subjects with Advanced Solid Tumors *First in Man Trial*
  • A Four-Part, Open-Label Study to Evaluate the Effects of Repeat Dose GSK2118436 on the Single Dose Pharmacokinetics of Warfarin, the Effects of Repeat Dose Oral Ketoconazole and Oral Gemfibrozil on the Repeat Dose Pharmacokinetics of GSK2118436, and the Repest Dose Pharmacokinetics of GSK2118436 in Subjects with BRAF Mutant Solid Tumors
  • A Registry of the Target Now Test Results (Biomarker Expression Patterns) for Evaluation of Correlation with Clinical Outcomes for Cancer Patients
  • Total Cancer Care: A Partnership with High Risk and/or Diagnosed Cancer Patients for Life
  • Phase I, open-label, crossover, randomized, bioequivalence study to evaluate two formulations of bendamustine hydrochloride administered to cancer patients
  • A phase 1A/1B, multicenter, open label, dose finding study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of the pleiotropic pathway modifier CC-122 administered orally to subjects with GBM, DLBCL, HCC, or MM.
  • A phase 1b study of BBI608 administered with Taxol in patients with advanced malignancies (ovarian, breast, gastric, melanoma and head/neck ca, NSCLC)
  • A phase 1 Clinical Study of BBI608 in Adult Patients with Advanced Solid Tumors
  • A phase 1 first in human study evaluating the safety, tolerability, PK and PD of AMG 232 in patients with advanced solid tumors.
  • A dose finding, open label, phase 1 study of RX-5902 in subjects with advanced or metastatic solid tumors. *First In Man Trial*
  • Phase 1, Open-Lavel, Multiple-ascending Dose Trial to investigate the Safety, Tolerability, PKs, Biological and Clinical Activity of MSB0010718C in Subjects with NSCLC or Met Breast
  • A phase 1b, multi-center, two parallel group, open label, drug-drug interaction study to evaluate the effect of LDE225 on the PK's of bupropion (Wellbutrin)
  • A phase 1 open-label, multi-center, randomized, 2-period, crossover study to evaluate the bioequivalence of CC-486 (oral Azacitidine) tablets in adult cancer subjects
  • A phase 1 clinical study of BBI 503 in adult patients with advanced solid tumors (preferred: colorectal, pancreatic, renal cell, hepatocellular, head & neck ca & ovarian)
  • A Phase I Study of CC-486 as a Single Agent and in Combination with Carboplatin or ABI-007 in Subjects with Relapsed or Refractory Solid Tumors
  • A Phase I Clinical Study of BBI503 in Adult Patients with Advanced Solid Tumors
  • A phase 1A/1B, multicenter, open label, dose finding study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of the pleiotropic pathway modifier CC-122 administered orally to subjects with GBM, DLBCL, HCC, or MM.
  • A phase 1b study of BBI608 administered with Taxol in patients with advanced malignancies (ovarian, breast, gastric, melanoma and head/neck ca, NSCLC)

Bladder

  • A Phase I Dose-Escalation Trial of Intravesical CG0070 and DDM for Superficial Transitional Cell Carcinoma of the Bladder after Bacillus Calmette-Guerin Failure: *First in Man Trial* & **Gene Transfer Trial**
  • Phase 1b trial of the combination of PI3K inhibitor BAY 86-9766 in subjects with advanced cancer

Brain

  • A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients with Temozolomide-Resistant Anaplastic Glioma

Breast

  • A phase I/Ib, multi-center, open-label study of BEZ235, administered orally on a continuous daily dosing schedule in adult patients with advanced solid malignancies including patients with advanced breast cancer
  • An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer
  • An Open Label Phase II Study of E7070 in Metastatic Breast Cancer Patients Previously Treated with an Anthracycline, Taxane and Capecitabine
  • A Randomized Phase II Trial of Three Doses of Perifosine in Combination with Trastuzumab for Metastatic Breast Cancer Patients
  • A Phase II Trial of Two Schedules of Perifosine n Combination with Endocrine Therapy for Patients with Estrogen Receptor or Progesterone Receptor Positive Metastatic Breast Cancer
  • A Phase 1 Open label Food Effect study to examine the effects of Low-fat and High-fat meals on the Pharmacokinetics
  • Randomized, Open-Label Study of Ad-RTS-hIL-12 Monotherapy or Combination with Palifosfamide-tris in Subjects with Recurrent/Metastatic Breast Cancer and Accessible Lesions
  • A Phase I Study of CC-486 as a Single Agent and in Combination with Carboplatin or ABI-007 in Subjects with Relapsed or Refractory Solid Tumors
  • A Phase I Clinical Study of BBI503 in Adult Patients with Advanced Solid Tumors
  • A Phase I, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmadynamics of AMG 820 in Adult Subjects with Advanced Solid Tumors *First in Man Trial*
  • A Four-Part, Open-Label Study to Evaluate the Effects of Repeat Dose GSK2118436 on the Single Dose Pharmacokinetics of Warfarin, the Effects of Repeat Dose Oral Ketoconazole and Oral Gemfibrozil on the Repeat Dose Pharmacokinetics of GSK2118436, and the Repest Dose Pharmacokinetics of GSK2118436 in Subjects with BRAF Mutant Solid Tumors
  • A Registry of the Target Now Test Results (Biomarker Expression Patterns) for Evaluation of Correlation with Clinical Outcomes for Cancer Patients
  • Total Cancer Care: A Partnership with High Risk and/or Diagnosed Cancer Patients for Life
  • Phase I, open-label, crossover, randomized, bioequivalence study to evaluate two formulations of bendamustine hydrochloride administered to cancer patients
  • A phase 1A/1B, multicenter, open label, dose finding study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of the pleiotropic pathway modifier CC-122 administered orally to subjects with GBM, DLBCL, HCC, or MM.
  • A phase 1b study of BBI608 administered with Taxol in patients with advanced malignancies (ovarian, breast, gastric, melanoma and head/neck ca, NSCLC)
  • A phase 1 Clinical Study of BBI608 in Adult Patients with Advanced Solid Tumors
  • A phase 1 first in human study evaluating the safety, tolerability, PK and PD of AMG 232 in patients with advanced solid tumors.
  • A dose finding, open label, phase 1 study of RX-5902 in subjects with advanced or metastatic solid tumors. *First In Man Trial*
  • Phase 1, Open-Lavel, Multiple-ascending Dose Trial to investigate the Safety, Tolerability, PKs, Biological and Clinical Activity of MSB0010718C in Subjects with NSCLC or Met Breast
  • A phase 1b, multi-center, two parallel group, open label, drug-drug interaction study to evaluate the effect of LDE225 on the PK's of bupropion (Wellbutrin)
  • A phase 1 open-label, multi-center, randomized, 2-period, crossover study to evaluate the bioequivalence of CC-486 (oral Azacitidine) tablets in adult cancer subjects
  • A phase 1 clinical study of BBI 503 in adult patients with advanced solid tumors (preferred: colorectal, pancreatic, renal cell, hepatocellular, head & neck ca & ovarian)
  • A Phase I, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination with IM Fulvestrant to Patients with Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer
  • A phase 1b study of LY2835219 in combination with endocrine therapies for pt's with hormone receptor positive, HER2 Neg met breast ca

Colorectal

  • Phase I Parallel Arm Study of MK-0646 (Dalotuzumab) + MK-2206 and MK-0646
    (Dalotuzumab) + MK-0752 Doublets (MK-MK Doublets) in Patients with Advanced Cancer (ovarian and colon) A Phase Ib/II Trial of AMG 655 in Combination with Panitumumab in Subjects with Metastatic Colorectal Cancer
  • A Randomized, Phase Ib/II Trial of AMG 102 or AMG 479 in Combination with Panitumumab versus Panitumumab Alone in Subjects with Wild-Type KRAS Metastatic Colorectal Cancer
  • An Open-Label, Dose-Finding Study to Evaluate the Safety of AMG 706 Plus Panitumumab Plus Chemotherapy in the Treatment of Subjects with Metastatic Colorectal Cancer
  • A Phase Ib/II Study of AMG 655 in Combination with Modified FOLFOX6 and Bevacizumab for the First-Line Treatment of Subjects with Metastatic Colorectal Cancer
  • A Phase I/II, Open-Label Study with Sequential Dose Escalation Stage Followed by an Expansion of a Selected Dose Cohort, to Evaluate the Safety and Anti-tumor Effects of NV1020, Administered Repeatedly via Hepatic Artery Infusion Prior to Second Line Chemotherapy, in Patients with Colorectal Adenocarcinoma Metastatic to the Liver
  • A Phase II, Randomized, Double‑Blind, Placebo Controlled Study of AMG 386 in Combination with FOLFIRI in Subjects with Previously Treated Metastatic Colorectal Carcinoma
  • An Exploratory Pharmacogenomic Study of Erbitux® Monotherapy in Patients with Metastatic Colorectal Carcinoma (CA225045)

Head and Neck

  • A Phase III, Multi-Center, Open-Label, Randomized Study to Compare the Effectiveness and Safety of Intratumoral Administration of INGN 201 in Combination with Chemotherapy Versus Chemotherapy Alone in Patients with Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck: **Gene transfer trial**

Hepatocellular

  • A Phase I/II Study of RDEA119 and Sorafenib in Patients with Hepatocellular Cancer
  • Phase I Open-Label Study with a Sequential Dose Escalation Stage Followed by an Expansion of a Selected Dose Cohort to Evaluate the Safety and Anti-Tumor Effects of NV1020, Administered Repeatedly Via Hepatic Artery Infusion Prior to Second-Line Chemotherapy, in Patients with Colorectal Carcinoma Metastatic to the Liver: **Gene transfer trial**

Idiopathic Thrombocytopenia (ITP)

  • A Phase II, Parallel Group, Rollover Study of AKR-501 in Patients with Chronic Idiopathic Thrombocytopenic Purpura (ITP) Who Completed 28 Days of Study Treatment in Protocol 501-CL-003

Lung

Non Small Cell Lung Cancer

  • Phase III Double-blind, Placebo-Controlled Study of Lucanix as Maintenance Therapy for Stages III/IV NSCLC Who Responded to or Have Stable Disease Following One Front Line Platinum-based Therapy: **Gene transfer trial**
  • A Randomized Phase Two Study of SCH 727965 in Subjects with Advanced Breast and Non-Small Cell Lung Cancer
  • A Phase II, Multi‑center, Open Label, Randomized Trial of AMG 706 or Bevacizumab in Combination with Paclitaxel and Carboplatin for Advanced Non‑squamous Non‑small Cell Lung Cancer
  • A Phase Ib/ II Study of AMG 479 in Combination with Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer
  • An open-label, dose-finding study to evaluate the safety and pharmacokinetics of AMG 706 with Carboplatin/Paclitaxel, AMG 706 with Panitumumab and AMG 706 with Panitumumab and Carboplatin/Paclitaxel in the Treatment of Subjects with Advanced Non-Small Cell Lung Cancer
  • Phase II Study of the Feasibility to Derive Autologous Vaccine (HSPPC-96) From Tumor Tissue for Clinical Administration in Patients with Resectable Non-Small Cell Lung Cancer
  • Phase I Open-Label Dose Escalation Trial Evaluating The Safety And Immunogenicity Of Sequential Administration Of Recombinant DNA And Adenovirus Expressing L523s Protein In Patients With Early Stage Non-Small Cell Lung Cancer
  • An Open Label, Multi-center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients with Stage IIB or IIIA Non-Small Cell Lung Cancer (NSCLC)
  • A Phase II, Open Label, Multi-center Study of EP2101 Therapeutic Vaccine in Patients with Stage IIIb, Stage IV, or Recurrent Non-Small Cell Lung Cancer
  • Phase I Open-Label Dose Escalation Trial Evaluating the Safety and Immunogenicity of Sequential Administration of Recombinant DNA and Adenovirus Expressing L523S Protein in Patients with Early Stage Non-Small Cell Lung Cancer: **Gene Transfer Trial**
  • A Phase I/II Trial of Perifosine inn the Treatment of Non-Small Cell Lung Cancer
  • A Phase I/II Study of Weekly OGX-011 Plus Gemcitabine/Platinum-Based Regimen in Patients with Stage IIIB or IV Non-Small Cell Lung Cancer
  • An Open-Label, Multi-center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients with Stage IIb or IIIa Non-Small Cell Lung Cancer
  • Phase I Open-Label Dose Escalation Trial Evaluating the Safety and Immunogenicity of Sequential Administration of Recombinant DNA and Adenovirus Expressing L5235 Protein in Patients with Early Stage Non-Small Cell Lung Cancer
  • A Phase Ib/2 Trial of AMG 386 in Combination with Pemetrexed and Carboplatin as First Line Treatment of Metastatic Non-Small Cell Lung Cancer
  • A Randomized Pase 2 Study of LY2510924 and Carboplatin/Etoposide versus Carboplatin/Etoposide in Extensive-Stage Small Cell Lung Carcinoma
  • A Phase 1B, Mulit-Center, Open-Label Study of the MTOR Kinase Inhibitor CC-223 in Combination with Erlotinib or Oral Azacitidine in Advanced Non-Small Cell Lung Cancer
  • A lead-in phase 2 multicenter, randomized, double blind study comparing AZD1775/placebo plus Docetaxel in previously treated NSCLC patients

Small Cell Lung Cancer

  • A Phase Ib/II Trial of AMG 479 or AMG 102 in Combination with Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer
  • An Open-Label Phase II Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of a Single Dose of 200 mg i.v. BI 2536 BS Administered Every 21 days in Patients with Sensitive Relapse Small Cell Lung Cancer
  • A Phase I Followed by a Randomized, Phase II Study of Carboplatin and Etoposide with or Without Obatoclax Administered Every Three Weeks to Patients with Extensive-Stage Small Cell Lung Cancer

Lymphoma

  • A Phase I, Open-Label, Multi-Center, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Twice a Week in Adult Patients with Advanced Solid Malignancies including Lymphoma without Marrow Involvement
  • A Phase II Study of the Monoclonal Antibody CT-011 in Patients with Diffuse Large B-Cell Lymphoma following Autologous Peripheral Blood Stem Cell Transplantation
  • An Open-Label, Phase Ib Study of the Safety, Pharmacokinetics and Activity of the Anti-CD40 Monoclonal Antibody SGN-40, Administered in Combination with Rituximab in Patients with CD20 Positive Follicular and Marginal Zone B-Cell Non-Hodgkin's Lymphoma who have Relapsed Following Previous Rituximab Therapy
  • A Prospectively Randomized, Phase III, Multicenter, Controlled Trial to Evaluate the Safety and Efficacy of Zevalin Therapeutic Regimen Plus Rituxan Compared with Rituxan Alone in Patients with Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma
  • A Phase l/ll Study of CMC-544 Administered in Combination with Rituximab in Subjects with Follicular or Diffuse Large B-cell Non-Hodgkin's Lymphoma
  • A Phase 1/2 study of PT-100 administered twice daily for 6 days following each weekly administration of standard dose rituximab for 4 consecutive weeks in patients with chemotherapy-refractory or rituximab-relapsed indolent (low grade) non-Hodgkin's lymphoma
  • An Open Label, Phase I Study to Evaluate Safety and PK of Praletrexate in Relaplsed/Refractory Advanced Solid Tumor or Advanced Lymphoma/Myeloma Patients with Mild, Moderate, and Severe Renal Impairment

Melanoma

  • A Randomized Phase III Trial to Evaluate the Efficacy and Safety of Treatment with OncoVEX Compared to Subcutaneously Administered GM-CSF in Melanoma Patients with Unresectable stage IIIB, IIIC and IV Melanoma
  • An Open-label, Randomized, Phase 1b/II Study of E7080 in Combination with Dacarbazine Versus Dacarbazine Alone as First Line Therapy in Patients with Stage IV Melanoma
  • A Phase 2, Open-label Study to Assess the Safety and Efficacy of Oral MEK162 in Adults with Lcally Advanced and Unresectable or Metastatic Malignant Cutaneous Melanoma, Harboring BRAF or NRAS Mutations
  • Phase II, Open-Label, Two-Stage Study of Volociximab (M200) for the Treatment of Subjects with Metastatic Melanoma
  • An Open-Label Phase II Trial of Talabostat (PT-100) and Cisplatin in Patients with Metastatic Melanoma
  • A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Once Every 3 Weeks in Patients with Inoperable Locally Advanced or Metastatic Melanoma
  • A Randomized, Double-blind, Phase 3 Trial of STA-4783 in Combination with Paclitaxel versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects With Stage IV Metastatic Melanoma
  • Procurement of Tissues for Preparation of the Autologous Dendritoma Vaccine, Melaxin™
  • Phase II Study of a Multi-Antigen Therapeutic vaccine in Patients with Metastatic Melanoma
  • Open Label Trial in Patients with Stage IV Malignant Melanoma Using Melaxin™ as a Cancer Vaccine in Conjunction with BCG: *First in Man trial*
  • A Phase II Open-Label, Single-Arm "Proof of Concept" Study of TNFerade Plus Radiation in Patients with Metastatic Melanoma: **Gene Transfer Trial**
  • A Phase II, Open-Label, Two-Stage Study of M200 for the Treatment of Subjects With Metastatic Melanoma
  • A Randomized Phase II Trial of ATN-224 in combination With Temozolomide or Temozolomide Followed by ATN-224 in Systemic-Treatment Naïve Patients With Advanced Melanoma
  • A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Once Every Three Weeks in Patients With Inoperable Locally Advanced Metastatic Melanoma
  • Phase II Study of a Multi-Antigen Therapeutic Vaccine in Patients With Metastatic Melanoma
  • A Phase I/II, Open-Label Study of JX-594 (Thymadine Kinase-Deleted Vaccinia Virus
  • Plus GM-CSF) Administered by Intratumoral Injection in Patients With Unresectable Stage III or IV Malignant Melanoma: **Gene Transfer Trial**
  • A Phase 1 Study of the Poly (ADP-Ribose) Polymerase Inhibitor E7016 in Combination with Temozolomide in Subjects with Melanoma or Other Advanced Solid Tumors
  • A Phase 1 Open Label, Dose Escalation Pharmacokinetic and Pharmacodynamic Study of E6201 in Subjects with Metastatic BRAF Mutated Melanoma
  • Phase 3, Randomized, Double-Blind Study of Nivolumab Montherapy or Nivolumab Combined with Ipilimumab Versus Ipilimumab Monotherapy in Subjects with Previously Untreated Unresectable or Metastatic Melanoma
  • A Phase Ib Clinical Study of BBI608 Administered with Paclitaxel in Adult Patients with Advanced Malignancies
  • A Four-Part, Open-Label Study to Evaluate the Effects of Repeat Dose GSK2118436 on the Single Dose Pharmacokinetics of Warfarin, the Effects of Repeat Dose Oral Ketoconazole and Oral Gemfibrozil on the Repeat Dose Pharmacokinetics of GSK2118436, and the Repest Dose Pharmacokinetics of GSK2118436 in Subjects with BRAF Mutant Solid Tumors

Multiple Myeloma

  • A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX-4945 Administered Orally to Patients with Relapsed or Refractory Multiple Myeloma
  • A Phase I Study of Dasatinib with Bortezomib (Velcade®) and Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma
  • An Open Label, Phase I Study to Evaluate Safety and PK of Praletrexate in Relaplsed/Refractory Advanced Solid Tumor or Advanced Lymphoma/Myeloma Patients with Mild, Moderate, and Severe Renal Impairment

Myelodysplasia

  • A Phase I, Multi-Dose Study of SGN-33 (anti-huCD33 mAb; HuM195; lintuzumab) in patients with Acute Myeloid Leukemia and Myelodysplastic Syndrome
  • A Phase 1/b, Open-Label, Multi-Center, Dose-Escalation Study of Oral Panobinostat Administered with 5-Azacitidine in Adult Patients with Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) or Acute Myelogenous Leukemia (AML)

Ovarian

  • Phase I Parallel Arm Study of MK-0646 (Dalotuzumab) + MK-2206 and MK-0646
    (Dalotuzumab) + MK-0752 Doublets (MK-MK Doublets) in Patients with Advanced Cancer (ovarian and colon)
  • A Phase Ib Clinical Study of BBI608 Administered with Paclitaxel in Adult Patients with Advanced Malignancies
  • A Four-Part, Open-Label Study to Evaluate the Effects of Repeat Dose GSK2118436 on the Single Dose Pharmacokinetics of Warfarin, the Effects of Repeat Dose Oral Ketoconazole and Oral Gemfibrozil on the Repeat Dose Pharmacokinetics of GSK2118436, and the Repest Dose Pharmacokinetics of GSK2118436 in Subjects with BRAF Mutant Solid Tumors

Pancreas

  • A Phase 1b/2 Study Evaluating IPI-926 in Combination with Gemzar in Patients with Metastatic Pancreatic Cancer
  • A Randomized Cross-over Phase II Study of the Safety and Efficacy of Two Dose Levels of TH-302 in Combination with Gemcitabine Compared with Gemcitabine Alone in Previously Untreated Patients with Locally Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma
  • Safety, Tolerability and Pharmacokinetic Assessment of CG53135 Administered Intravenously in Patients with Advanced (Stage 4) Colorectal, Esophageal, Gastric, or Pancreatic Cancer (Single Rising-Dose Tolerance Study)
  • A Global, Multi-center, Open-label, Phase II Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects with Metastatic Pancreatic Cancer
  • A Phase III Randomized, Controlled Study to Evaluate the Safety and Efficacy of PANVACTM-VF in Combination with GM-CSF Versus Best Supportive Care or Palliative Chemotherapy in Patients with Metastatic (Stage IV) Adenocarcinoma of the Pancreas
  • An Open-Label Phase II Trial of Talabostat and Gemcitabine in Patients with Stage IV Adenocarcinoma of the Pancreas
  • Multicenter Study to Evaluate the Safety and Efficacy of PANVAC-VF in Combination with GM-CSF Versus Best Support Care in Patients with Metastatic Pancreatic Cancer: **Gene transfer trial**
  • A Randomized, Phase II Study of TNFerade Biologic With –FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer: **Gene transfer trial**
  • Safety and Efficacy of the Therapeutic Vaccine GI-4000 in Combination With Gemcitabine Versus Placebo for the Treatment of Non-metastatic, Post-resection Pancreas Cancer: **Gene transfer trial**
  • A Phase 1b/2 study of OMP-59R in combo with Gemzar/Abraxane in pt's with untreated stage 4 pancreatic ca (part 2 will be opening soon - randomized to Gem/Abraxane +/- OMP-59R5)
  • A phase 1b/2 study of OMP-59R/placebo in combo with Gemzar/Abraxane in pt's with untreated stage 4 pancreatic ca

Prostate

  • A Phase I Dose-escalation Study of PSMA ADC in Subjects with Progressive, Castration-resistant Metastatic Prostate Cancer
  • Phase I Dose Escalation of TOK-001 for the Treatment of Chemotherapy Naive Castration Resistant Prostate Ca with No Hepatic Metastases: *First in Man trial*
  • A Phase I study of ZD4054 in Combination with Docetaxel in 2 Parts, an Open-Label. Non-Randomized, Dose-Finding Part and a Double-Blind, Placebo-Controlled, Randomized Dose Expansion Part, in Patients with Metastatic Hormone-Refractory Prostate Cancer
  • Three Arm Randomized Phase II Clinical Study of Irofulven/Prednisone, Irofulven/Capecitabine/Prednisone or Prednisone Alone in Docetaxel-Pretreated Hormone Refractory Prostate Cancer Patients
  • A Phase lll Randomized, Open-Label Study of Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients with Metastatic Hormone-Refractory Prostate Cancer With Pain: **Gene transfer trial**
  • Three Arm Randomized Phase II Clinical Study of Irofulven/Prednisone, Irofulven/Capecitabine/Prednisone or Prednisone Alone in Docetaxel-Pretreated Hormone-Refractory Prostate Cancer Patients
  • A Phase II, Multicenter, Randomized Study of IMC-AI2 or IMC-112B and Mitoxantrone and Prednisone in Metastatic Androgen-Independent Prostate Cancer (AIPC) Following Disease Progression on Docetaxel-Based Chemotherapy
  • A Phase I and Pharmacologic Study of MM-111 in Combination with Multiple Treatment Regimens in Patients with Advanced Her2 Positive Solid Tumors
  • A Phase 2, Open-label, Multicenter Study of PSMA ADC in Subjects with Metastatic Castration-resistant Prostate Cancer

Renal

  • A Phase 1b Study of LY573636-sodium in Combination with Sunitinib Malate in Patients with Metastatic Renal Cell Cancer
  • A Phase I Dose Escalation Trial to Evaluate the Safety and Tolerability of CP-675,206 Administered in Combination with SU011248 for Patients with Metastatic Renal Cell Carcinoma
  • A Phase I, Open-label, Dose-escalation, Multidose Study of MDX-1411 Administered Every 14 Days in Subjects with Advanced or Recurrent Clear Cell Renal Cell Carcinoma
  • An International, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Investigate Whether TroVax, Added to First-Line Standard of Care Therapy, Prolongs the Survival of Patients with Locally Advanced or Metastatic Clear Cell Renal Adenocarcinoma
  • An Open Label Phase II Trial of Talabostat (PT 100) and Gemcitabine in Patients with Unresectable Renal Cell Carcinoma
  • Phase I, Open-Label Trial in Patients with Stage III or Stage IV Renal Cell Carcinoma Using Dendritomas as a Cancer Vaccine in Conjunction with BCG: *First in Man trial*
  • Randomized, Multicenter, Open-Label, Active-Controlled, Phase 2 Study of LY2510924 and Sunitinib versus Sunitinib in Patients with Metastatic Renal Cell Carcinoma
  • A phase 1b/2 study of OMP-59R/placebo in combo with Gemzar/Abraxane in pt's with untreated stage 4 pancreatic ca

Sarcoma

  • A Phase II Trial of Perifosine in Patients With Sarcoma

Thyroid

  • A Phase II Open-label Study of AMG 706 to Treat Subjects with Locally Advanced or Metastatic Thyroid Cancer