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Clinical Trials Monthly - March 2013

This month's featured clinical trials include:

Colorectal Cancer

Lung Cancer

Hotlist of new clinical trials

Colorectal Cancer

GS-6624 with FOLFIRI as Second-Line Treatment for Colorectal Cancer

A Phase II Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined with FOLFIRI as Second Line Treatment for Metastatic KRAS Mutant Colorectal Adenocarcinoma that has Progressed Following a First Line Oxaliplatin- and Fluoropyrimidine-Containing Regimen

The purpose of this study is to test the effectiveness and safety of investigational drug GS-6624 for the treatment of colorectal adenocarcinoma, a sub-type of cancer of the colon or rectum, at different dose levels. The study drug will be given with FOLFIRI, a treatment approved by the U.S. Food and Drug Administration (FDA) for colorectal adenocarcinoma treatment.

GS-6624 is an experimental drug being developed to treat many different diseases including myelofibrosis. The enzyme LOXL2 (a small protein found in the body) is important in the growth and spread of cancer cells as it helps the supporting tissue around the cells to grow. GS-6624 is an antibody, which is a Y-shaped protein that selectively binds to LOXL2, and in doing so causes changes in the supporting tissue which leads to destruction of the cancer cells. Therefore, GS-6624 may stop the growth and spread of cancer cells. Investigator: Andrew Coveler, MD


TheraSphere® Metastatic Colorectal Carcinoma of the Liver (7627)

A Phase III Clinical Trial Evaluating TheraSphere® in Patients with Metastatic Colorectal Carcinoma of the Liver Who Have Failed First-Line Chemotherapy

This study will help determine the effectiveness and safety of TheraSphere® in patients with colorectal cancer metastases to the liver who are scheduled to receive second-line chemotherapy. All patients will receive the standard of care chemotherapy with or without the addition of TheraSphere.

TheraSphere treatment, also known as radioembolization or selective internal radiation therapy (SIRT), is a low toxicity, targeted liver cancer therapy that consists of millions of tiny glass beads containing radioactive yttrium-90. The glass radioactive beads (a mean diameter of 20-30 micrometers) are delivered directly to liver tumors via the hepatic artery and become permanently lodged in the small blood vessels there. Radiation destroys the tumor cells from inside the tumor with little impact on the surrounding liver tissue. These radioactive microspheres emit radiation over the course of several weeks and radiation levels will eventually decrease to insignificant levels. Investigator: William P. Harris, MD
 

Lung Cancer

ABRAXANE® (Nab-Paclitaxe l) for Advanced Non-Small Cell Lung Cancer (7755)

Phase II study of Weekly Abraxane® (nab-paclitaxel) for Patients with Advanced NSCLC with EGFR Mutations Following Front-Line Therapy with EGFR Tyrosine Kinase Inhibitors

The purpose of this study is to see if Abraxane®, a chemotherapy approved for breast cancer treatment, will also work against lung cancer with the EGFR mutations. Patients on this study will receive Abraxane for six months and will be followed for their entire lives. Abraxane is a cancer drug that interferes with the growth and spread of cancer in the body. Investigator: Christina Baik, MD, MPH


BMS-936558 Vs Docetaxel for Non-Small Cell Lung Cancer

An Open-Label, Randomized Phase III Trial of BMS-936558 Versus Docetaxel in Previously Treated or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to test the effectiveness, safety, and tolerability of the experimental drug BMS-936558, an antibody that is being tested to see if it will allow the body’s immune system to work against tumor cells. The effectiveness of BMS-936558 in lung cancer will be determined by comparing the observed change in tumor size and the survival of subjects who receive the investigational drug BMS-936558 to those who receive docetaxel, an accepted standard of care therapy. Not yet approved by the FDA, results from a trial presented at last year’s American Society of Clinical Oncology showed that BMS-936558 shrunk the tumors in 18 to 28 percent of patients with advanced lung, kidney, and skin cancers. Investigator: Laura Q.M. Chow, MD


Trials Hotlist

NCI Designation
Disease Site
Trial Description
NCT01492101
Breast Cancer
The BEACON Study (Breast Cancer Outcomes with NKTR-102): A Phase III Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician’s Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline, a Taxane and Capecitabine
NCT01720602
Breast Cancer
A Pilot Study of Vorinostat to Restore Sensitivity to Aromatase Inhibitor Therapy Part B

NCT01478594


Colorectal Cancer

Phase II, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination with mFOLFOX6
with Bevacizumab in Combination with mFOLFOX6 in Stage IV Metastatic Colorectal Cancer (mCRC) Subjects

NCT01196390

Esophageal Cancer

A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma

NCT01333033

Esophageal Cancer

Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer

NCT01412229

Head/Neck Cancer

Phase II Study of Carboplatin, Nab-Paclitaxel, and Cetuximab for Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

NCT01690520

Leukemia

Multicenter, Open-Label Randomized Study of Single or Double Myeloablative Cord Blood Transplantation with
or without Infusion of Off-the-Shelf exVivo Expanded Cryopreserved Cord Blood Progenitor Cells in Patients with Hematologic Malignancies

NCT01701323

Leukemia

Pilot Study Evaluating the Use of Ex Vivo Expanded Cord Blood Progenitors as Supportive Care Following Induction hemotherapy (FLAG) in Patients with Rlapsed/Refractory AML

NCT01287585

Liver Cancer

POLARIS2009-001: A Randomized, Double-Blind, Multicenter Phase III Study of ADI PEG 20 Plus Best Supportive are (BSC) Versus Placebo Plus BSC in Subjects with Advanced Hepatocellular Carcinoma (HCC) Who have Failed Prior Systemic Therapy

NCT01642004

Lung Cancer

An Open-Label Randomized Phase III Trial of BMS-936558 Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-Small Cell Lung Cancer (NSCLC)

NCT01673867

Lung Cancer

An Open-Label Randomized Phase III Trial of BMS-936558 versus Docetaxel in Previously Treated or Metastatic
Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

NCT01712217

Lung Cancer

A Study of HSP90 Inhibitor AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-Small Cell Lung Cancer (NSCLC)

NCT01678443

Lymphoma

A Phase I Study Evaluating Escalating Doses of 90Y-BC8-DOTA (Anti-CD45) Antibody Followed by Autologous Stem Cell Transplantation for Relapsed or Refractory Lymphoid Malignancies

NCT01621490

Melanoma

An Exploratory Study of the Biologic Effects of BMS-936558 (Anti-PD-1 Monoclonal Antibody) Treatment in Subjects with Advanced Melanoma (Unresectable or Metastatic)

NCT01691898

Non-Hodgkin’s
Lymphoma

A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of DCDT2980S in Combination with Rituximab or DCDS4501A in Combination with Rituximab in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma

NCT01170650

Ovarian Cancer

A Randomized Double-Blind Phase III Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/DOXIL®/CAELYX®) in Combination Versus PLD in Participants with Platinum-Resistant Ovarian Cancer

NCT01485848

Ovarian Cancer

EP-100, a Novel LHRH Receptor-Targeted Membrane-Disruptive Peptide, plus Paclitaxel® versus Paclitaxel® Alone for Refractory or Recurrent Ovarian Cancer: A Phase II, Randomized, Multicenter Trial

NCT01360853

Pancreatic Cancer

A Phase II/III, Multicenter, Randomized, Controlled Study to Compare the Efficacy and Safety of Gemcitabine Alone versus ON 01910.Na Combined with Gemcitabine in Patients with Previously Untreated Metastatic Pancreatic Cancer

NCT01503229

Prostate Cancer

Open-Label Pharmacodynamic Study of Abiraterone in the Treatment of Metastatic, Castration Resistant Prostate Cancer

NCT01034631

Renal Cell Carcinoma

Phase I/II Study of BNC105P in Combination with Everolimus or Following Everolimus for Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine Kinase Inhibitors

NCT01574716

Sarcoma

A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel in Metastatic Soft Tissue Sarcoma

NCT01602211

Survivorship

INSPIRE for Survivorship after Transplant: A Multicenter Randomized Controlled Trial of an Internet and Social Media Program for Long-Term Hematopoietic Cell Transplantation Survivors


 

Related Documents:

03-05-2013 SCCA Clinical Trials Monthly - March 2013 (194kb)

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