Scleroderma Lung Study III (SLS III): Combining the anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma-related interstitial lung disease Save

Date Added
May 8th, 2018
PRO Number
Pro00077568
Researcher
Richard Silver

Silhouette
Keywords
Autoimmune disease, Drug Studies, Lung, Scleroderma, Shortness of Breath
Summary

This study will assess how 18 months of oral mycophenolate will compare to 18 months of mycophenolate plus pirfenidone, in the treatment of Systemic Sclerosis related Interstitial Lung Disease. Tolerability and toxicity will also be assessed, during this study.
This research is designed to test whether combining pirfenidone and mycophenolate will result in a more rapid and possibly greater improvement in lung function than occurs when mycophenolate is used alone. While both of these drugs have been approved by the U.S. Food and Drug Administration (FDA) to treat other medical conditions, neither drug has been FDA-approved for the treatment of scleroderma related lung disease. This research is being funded by the drug company, Genentech.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5290
gibsonke@musc.edu

A Phase III Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients who have Failed a First-Line Platinum-Containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303) Save

Date Added
May 7th, 2018
PRO Number
Pro00077046
Researcher
Theodore Gourdin

Silhouette
Keywords
Cancer/Genitourinary, Drug Studies, Men's Health, Urinary, Women's Health
Summary

This study evaluates the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation Save

Date Added
April 10th, 2018
PRO Number
Pro00075889
Researcher
Daniel Judge

Silhouette
Keywords
Cardiovascular, Drug Studies, Genetics
Summary

The purpose of this research study is to test if ARRY-371797 is safe and effective in treating dilated cardiomyopathy caused by a genetic mutation to the LMNA gene. This will be demonstrated by the functional capacity of patients in their 6-minute walk tests and quality of life questionnaires.

Institution
MUSC
Recruitment Contact
Anita Smalls
843-876-5011
smaani@musc.edu

A randomized, double-blind Phase II study of pembrolizumab versus placebo in patients with head and neck cancers at high risk for recurrence or low-volume residual disease ? the PATHWay Study Save

Date Added
March 27th, 2018
PRO Number
Pro00076352
Researcher
John Kaczmar

Silhouette
Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with squamous cell carcinoma of the head and neck (SCCHN). The investigational drug in this study is Pembrolizumab. The main purpose of this study is to attempt to reduce the risk of cancer recurrence using a drug called pembrolizumab. Participants can expect to be in this study for approximately 5 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer Save

Date Added
March 27th, 2018
PRO Number
Pro00075360
Researcher
Carolyn Britten

Silhouette
Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies, Pancreas
Summary

This study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer. There is not a set number of clinic visits and subjects can remain on study provided their disease is at least stable for each imaging time point, and if study drugs are sufficiently tolerated

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 2, Prospective, Randomized, Open-label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus- Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant Save

Date Added
February 27th, 2018
PRO Number
Pro00072922
Researcher
Michelle Hudspeth

Silhouette
Keywords
Cancer, Cancer/Leukemia, Children's Health, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects who have been diagnosed with acute leukemia or myelodysplastic syndrome (MDS) and are a candidate for allogeneic hematopoietic stem cell transplant (HSCT). The study is being done to learn if adding defibrotide to the standard medicines for prevention of acute Graft-versus-Host Disease (aGvHD), which is called immunoprophylaxis, will help to prevent aGvHD better than using the usual immunoprophylaxis medicines alone. The investigational drug in this study is called Defibrotide. The duration of participation for each patient is approximately 6 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Feasibility of an Electronic Geriatric Assessment (EGA) for Older Adults with Cancer Save

Date Added
February 15th, 2018
PRO Number
Pro00075247
Researcher
Amarinthia Curtis
Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to learn more about older adults (age 65 and older) with cancer and their overall health by completing a survey called a "geriatric assessment" (GA). A GA is designed to gather information about a patient's nutritional status, mental health, spiritual health, social support, and memory. In addition, it informs health care providers about how well you carry out your daily activities and collects information on the other health problems you may have.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML Save

Date Added
February 13th, 2018
PRO Number
Pro00072488
Researcher
Robert Stuart

Silhouette
Keywords
Cancer, Cancer/Leukemia, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with acute myeloid leukemia (AML) with a genetic mutation called FLT3/ITD. The investigational drug in this study is called gilteritinib (ASP2215). The main purpose of this study is to learn if it is safe and effective to treat patients who have FLT3/ITD AML with a study drug called gilteritinib (ASP2215) after transplant. The sponsor wants to know if this drug works better than a placebo to stop the AML from coming back. Participants can expect to be in this study for up to 7 years after they start the study drug.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Theta-Burst Stimulation As A Tool To Change Smoking Behavior Save

Date Added
February 6th, 2018
PRO Number
Pro00074722
Researcher
Colleen Hanlon

Silhouette
Keywords
Drug Studies, Psychiatry, Smoking
Summary

The purpose of this study is to develop theta burst transcranial magnetic stimulation (tbTMS) as a potential treatment for nicotine addiction. Theta burst TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). This study will test whether tbTMS over the forehead can produce a reduction in things that may prompt you to want to smoke cigarettes. TMS has been approved by the Food and Drug Administration as an investigational tool as well as a therapy for depression. However, TMS is not approved by the Food and Drug Administration as a treatment for nicotine cravings and other addictions.

This study consists of one consent session and one TMS session (can be on same day). Subjects will be asked to complete a series of questionnaires and computer assessments on how you think about nicotine and one session of TMS will be completed.

Institution
MUSC
Recruitment Contact
Julia Imperatore
(843)-792-5560
imperato@musc.edu

Altering memories that increase risk of relapse in alcohol use disorders: A translational clinical neuroscience pilot investigation of a novel pharmacological agent. Save

Date Added
February 6th, 2018
PRO Number
Pro00073523
Researcher
Michael Saladin

Silhouette
Keywords
Alcohol, Drug Studies, Stage II
Summary

The proposed study will employ treatment-seeking AUD individuals who will be randomly assigned to receive either 15 mg of rapamycin (sirolimus) or placebo immediately after the first of two alcohol cue exposure sessions scheduled to occur on consecutive days. Subjective responses (i.e., craving) and physiological (heart rate & skin conductance) reactivity will be obtained before, during and after cue presentations in both sessions. The durability of any observed treatment effects will be assessed in a Follow-up session performed approximately 10 days following completion of the second session. Treatment effects on self-report measures of drinking behavior during the approximately 10 days preceding the Follow-up session will also be assessed.

Institution
MUSC
Recruitment Contact
Emily Burns
843-792-6984
burnsemi@musc.edu

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