TDR11326 - Randomized, double-blind, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending repeated doses of SAR156597 in patients with idiopathic pulmonary fibrosis (IPF) + save

Date Added
May 28th, 2013
PRO Number
Pro00016950
Researcher
Timothy Whelan
Keywords
Drug Studies, Lung, Pulmonary
Summary

The purpose of this study is to determine if SAR156597 given by subcutaneous injection (injection under the skin) for up to 6 weeks (total of 7 injections), is safe compared to placebo (an inactive solution injection).

SAR156597 is a type of drug called monoclonal antibody (a type of protein) that blocks specific chemicals in your body. SAR156597 is an investigational drug that has not been approved for marketing by the health authorities.

Participants in this study will be randomly (by chance; similar to a flip of a coin) assigned to receive 1 of 3 doses of SAR156597 (50 mg, 100 mg, or up to 200 mg per injection) or placebo.

Your participation in this study may last up to 22 weeks and include 12 study visits.

Institution
MUSC
Recruitment Contact
Farah Stokes
843-792-3169
flaitz@musc.edu

A Phase I/II, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR610 Given Weekly in Subjects with Solid Tumors + save

Date Added
May 14th, 2013
PRO Number
Pro00023126
Researcher
Keisuke Shirai
Keywords
Cancer, Cancer/Lung, Lung
Summary

The purpose of this research study is to review the effectiveness and safety of PR610, including the dose level and side effects, for the treatment of adults diagnosed with non-squamous, nonsmall cell lung cancer (NSCLC).

Institution
MUSC
Recruitment Contact
Jessica Salamacha
843-792-6429
salamach@musc.edu

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) Protocol: GS-322-0207 + save

Date Added
April 23rd, 2013
PRO Number
Pro00024238
Researcher
Timothy Whelan
Keywords
Lung, Pulmonary
Summary

The purpose of this study is to see if GS-6624 is safe and if it will help to slow the progression of IPF disease. It will have one of 500 subjects at about 120 sites. This is a randomized, double-blind, placebo-controlled study.

Institution
MUSC
Recruitment Contact
Farah Stokes
843-792-3169
flaitz@musc.edu

A Randomized, Multicenter, Open-Label, Phase 2 Study of Paclitaxel-Carboplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Paclitaxel-Carboplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) + save

Date Added
April 23rd, 2013
PRO Number
Pro00022723
Researcher
Carol Sherman
Keywords
Cancer/Lung, Lung
Summary

The purpose of this research study is to review the effectiveness and safety of necitumumab in combination with chemotherapy vs chemotherapy alone in adults diagnosed with Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC).

Institution
MUSC
Recruitment Contact
Jessica Salamacha
843-792-6429
salamach@musc.edu

A Retrospective Chest X-Ray Image Collection Study for CAD Development + save

Date Added
March 25th, 2013
PRO Number
Pro00008443
Researcher
James Ravenel
Keywords
Lung
Summary

The objective of this study is to obtain retrospective case data from digital chest x-ray images and to evaluate the sensitivity, specificity and false positive rate of the C-Vu CAD system for these chest exams

•VuCOMP will process lung nodule cases to estimate C-Vu's sensitivity.
•VuCOMP will process negative cases to estimate C-Vu's specificity and false positive rate.
•VuCOMP will process current and prior lung nodule cases to compare results.

Institution
MUSC
Recruitment Contact
Kimberly Argabright
843-792-8025
argabrig@musc.edu

A randomized, open-label, multicenter Phase IIIb study comparing two trastuzumab dosing regimens, each in combination with cisplatin/capecitabine chemotherapy, as first-line therapy in patients with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma who have not received prior treatment for metastatic disease + save

Date Added
February 12th, 2013
PRO Number
Pro00014963
Researcher
Steve Chin
Keywords
Cancer, Cancer/Gastrointestinal, Esophagus, Liver, Lung, Stomach
Summary

The main purpose of this study is to is to determine the duration of survival in patients receiving trastuzumab at different dose levels in combination with standard doses of cisplatin and capecitabine. We want to find out how different doses of trastuzumab affect patients and their metastatic gastric cancer or GEJ cancer, and whether a higher dose of trastuzumab will increase blood levels of trastuzumab and provide more benefit than the currently approved dose. Therefore, to check how much trastuzumab circulates in the blood with different doses, we will investigate trastuzumab blood levels by taking blood samples at various times before and after trastuzumab doses. We will also look at tumor growth, the safety and how tolerable trastuzumab is given at both dose regimens. Also, the study will investigate the time from when trastuzumab dosing begins until the cancer starts re-growing, if that happens.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu

Lung Volume Reduction Coil for Treatment in Patients with Emphysema (RENEW) Study + save

Date Added
October 9th, 2012
PRO Number
Pro00019734
Researcher
Charlie Strange
Keywords
Lung, Shortness of Breath
Summary

Pulmonary emphysema is associated with air trapping that compresses the diaphragm and causes shortness of breath. This research study will compare a lung volume reduction coil made by PneumRx with best supportive care (no treatment) to determine which group of participants can walk farther on a six-minute walk test at one year. The PneumRx RePneu Lung Volume Reduction Coil is a metal investigational device placed in lungs at the site of worst emphysema. The worst lobe in one lung is treated with coils at baseline and the other lung is treated four months later. Participants who do not receive coils may be eligible for a separate research study to receive coils at one year. This study has up to 14 visits over five years that must be performed at MUSC.

Institution
MUSC
Recruitment Contact
Laura Bailey
(843) 792-2072
baileyll@musc.edu

An open label two-stage study of orally administered BKM120 in patients with metastatic non-small cell lung cancer with activated PI3K pathway + save

Date Added
October 9th, 2012
PRO Number
Pro00011327
Researcher
Keisuke Shirai
Keywords
Cancer, Cancer/Lung, Lung
Summary

The main purpose of this study is to find out if the drug BKM120 is safe and has positive effects in people who have metastatic non-small cell lung cancer (NSCLC). The goal of this study is to find out if BKM120 has any effect in patients with non-small cell lung cancer with an activated PI3K pathway.
BKM120 is a medicine that has not been approved by the Food and Drug Administration for the treatment of people with this medical condition. BKM120 is currently not “on the market” in any country.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1462
salzers@musc.edu

A Comparison of an Automated Intermittent Bolus Technique with Basal Infusion for Continuous Paravertebral Blocks in Patients Undergoing Thoracotomy: Implications for Acute and Chronic Pain Control + save

Date Added
August 15th, 2012
IRB Number
20187
Researcher
George Guldan
Keywords
Cancer/Lung, Lung, Surgery
Summary

This study is designed to evaluate a new medication delivery technique to provide pain relief in the postoperative period following a VATS procedure. Participants in the study that receive the Paravertebral blocks in the study will either be assigned to a group of continuous or automated intermittent bolus infusion. The goal of the study is to discern whether one method of infusion is superior to the other in terms of controlling pain for patients undergoing the thoracotomy.

Institution
MUSC
Recruitment Contact
Dr. George Guldan III

guldan@musc.edu

A RANDOMIZED, PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF ONARTUZUMAB (MetMAb) IN COMBINATION WITH TARCEVA (ERLOTINIB) IN PATIENTS WITH MET DIAGNOSTICPOSITIVE NONSMALL CELL LUNG CANCER (NSCLC) WHO HAVE RECEIVED STANDARD CHEMOTHERAPY FOR ADVANCED OR METASTATIC DISEASE + save

Date Added
August 14th, 2012
PRO Number
Pro00014530
Researcher
Carol Sherman
Keywords
Cancer, Cancer/Lung, Lung, Stage III, Stage IV
Summary

This is a randomized, Phase III, multicenter, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of MetMAb in combination with erlotinib as compared with treatment with erlotinib alone in patients with incurable NSCLC identified to be Met diagnostic positive.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu