A Randomized, Double-Blind, Phase 3 Comparison of Platinum-Based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-Based Therapy as First-Line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer Save

Date Added
September 1st, 2019
PRO Number
Pro00083993
Researcher
Whitney Graybill

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

The purpose of this study is to determine if adding the investigational drugs (TSR-042 and Niraparib) to Standard Of Care delays or prevents ovarian cancer recurrence (prevents the ovarian cancer from coming back). Once eligibility is determined, participants will begin with one of two treatment periods. Also, there is a chance that participants will receive the placebo(s), which would not provide benefit. The first treatment period is the chemotherapy treatment period, and the second one is the maintenance treatment period. It is not known how long participation in this study may last.
The Sponsor and Study Doctors cannot and do not guarantee or promise that participants will receive any benefits from this study. There is a chance by taking the study drug participants cancer may not return or the return of cancer may be delayed. It is not known whether participants would benefit from the Study Drug. Also, there is a chance that participants will receive the placebo(s), which would not provide benefit. Therefore, participants may not get any direct benefit from taking part in this study. However, what is learned in this study may help in the treatment of ovarian cancer for women around the world and may advance scientific knowledge.

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

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination with Chemotherapy as First-Line Treatment in Patients with Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma Save

Date Added
August 28th, 2019
PRO Number
Pro00086110
Researcher
Daniel Reuben

List of Studies

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Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

This is a research study to compare the effects and safety, good or bad, of tislelizumab (also known as BGB-A317) plus chemotherapy against placebo (an inactive substance) plus chemotherapy for adults with locally advanced recurrent or metastatic esophageal squamous cell carcinoma to find out which is better. Subjects may continue study treatment during their participation in the study as long as there is no worsening of disease and they don't have intolerable side effects from the study treatment

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

A Phase II Study of Palbociclib (PD-0332991) in Combination with Ibrutinib in Patients with Previously Treated Mantle Cell Lymphoma Save

Date Added
August 27th, 2019
PRO Number
Pro00091524
Researcher
Irl Greenwell

List of Studies

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

This study is for subjects that have been diagnosed with mantle cell lymphoma (MCL) and have already received at least one form of treatment. This study will evaluate the effects, good and bad, of the study drugs palbociclib and ibrutinib in your type of cancer. The purpose of this study is to study the effects of an investigational combination of ibrutinib and a drug called palbociclib on MCL. The subject will be in the study for as long as you do not experience any unacceptable side effects and your cancer does not become worse.

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

ARCADIA-CSI (Cognition and Silent Infarcts) Save

Date Added
July 31st, 2019
PRO Number
Pro00091520
Researcher
Christine Holmstedt

List of Studies


Profiles_link
Keywords
Stroke
Summary

This is a research study looking to compare the effects (good and bad) of the ARCADIA study drugs (apixaban and aspirin) on the occurrence of silent strokes and memory loss after stroke.

This add-on study to the ARCADIA trial involves cognitive testing (tests designed to measure subjects memory, thinking, reasoning and understanding) and an MRI scan of their brain.

There will be about 5 study visits over the length of the study (approximately 3 years), or for a long as subjects are in the parent ARCADIA study.

Institution
MUSC
Recruitment Contact
Vicki Streets
843-792-8606
streetsv@musc.edu

A Phase 1 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Save

Date Added
July 23rd, 2019
PRO Number
Pro00088438
Researcher
John Wrangle

List of Studies

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Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Lung, Cancer/Skin
Summary

The study will have 2 parts (Part A and Part B). Part A of this research study (the dose escalation phase) will test the safety and effectiveness of the different doses of ALKS 4230 (study drug) to find the one that is the safest and most effective. Part B of this study (the dose expansion phase) will use the safe dosing determined in Part A to see how effectively the combination of ALKS 4230 and pembrolizumab treats your solid tumors.LKS 4230 is an investigational (experimental) drug; this means that is has not been approved by the US Food and Drug Administration (FDA) to treat your disease. This is an open-label study which means that all subjects will be taking the active study drugs.You can be in the study for as long as it is clinically beneficial to you.

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

A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis Save

Date Added
June 25th, 2019
PRO Number
Pro00088593
Researcher
Eric Zollars

List of Studies


Profiles_link
Keywords
Lupus
Summary

The purpose of this study is to see if a new medicine named BMS- 986165 will treat kidney inflammation caused by lupus (lupus nephritis). This study is a clinical trial?which is how new medicines are studied before they are approved by the FDA. This particular drug targets the JAK/STAT pathway to reduce autoimmunity and inflammation.

Lupus is an autoimmune disease, which means that your immune system not only attacks bacteria and viruses but also attacks your healthy cells and organs, affecting many parts of the body. Lupus can cause fever, joint pain, rash, sensitivity of the skin to sunlight, as well as other symptoms, and may lead to inflammation and organ damage.

Current treatments for lupus are mainly drugs that suppress the immune system such as cortisone-like drugs (for example prednisone) and cyclophosphamide (a potent drug sometimes used in treating certain types of cancer), and drugs commonly used to treat or prevent malaria (called antimalarials) such as hydroxychloroquine. Many of these treatments may have serious side effects if used for a long time.

Therefore, there is a need for new and effective treatments for lupus.

Institution
MUSC
Recruitment Contact
Amanda Pizzo
843-792-8613
pizzo@musc.edu

Investigation of safety and efficacy of NNC0174-0833 for weight management - a dose finding trial Save

Date Added
May 16th, 2019
PRO Number
Pro00086637
Researcher
Patrick O'neil

List of Studies


Profiles_link
Keywords
Obesity, Weight Control
Summary

NNC0174-0833 is a long acting medication that has been studied for management of diabetes. These trials showed a weight loss effect, so it is being studied here as a possible means of weight management treatment. The study seeks to determine the dose of NNC0174-0833, a long acting medication, which may be most effective for weight management for people suffering from overweight or obesity. This study is over a period of 26 weeks along with a 7-week follow-up period. Five doses of NNC0174-0833 will be compared against the drug liraglutide 3.0 mg and an inactive placebo.
Participants will be randomly assigned to receive one of these drugs. All participants will receive diet and physical activity counseling. Participants will inject themselves once-weekly or once-daily with study medication. The primary measure of the study will be weight change, body measurement, blood sugar measurement and safety and tolerability of the drug.

Institution
MUSC
Recruitment Contact
Mary Harley
843-792-5428
harleyma@musc.edu

A Randomized, Phase II Study of Ficlatuzumab with or without Cetuximab in Patients with Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Save

Date Added
March 12th, 2019
PRO Number
Pro00085004
Researcher
John Kaczmar

List of Studies

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

This study is for patients who have been diagnosed with Head and Neck Squamous Cell Carcinoma (HNSCC). The investigational drug used in this study is Ficlatuzumab. The main goals of this research study is to study the safety and effectiveness of Ficlatuzumab with or without Cetuximab, to determine which strategy will be more effective, as well as to learn the potential side effects of Ficlatuzumab alone or in combination with Cetuximab. It is unknown exactly how long participants can expect to be in the study. Subjects will receive treatment until the drug is no longer effective on their cancer.

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

International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis Save

Date Added
February 5th, 2019
PRO Number
Pro00084129
Researcher
Jacqueline Kraveka

List of Studies


Profiles_link
Keywords
Adolescents, Cancer, Pediatrics, Transplant
Summary

This study is for patients that have been diagnosed with multisystem Langerhans cell histiocytosis (LCH). The purpose of this study is to find out if prolonging the treatment and adding a drug called 6-mercaptopurine will be beneficial. Other goals include fining out if these changes will result in fewer patients having relapse of their LCH, and fewer patients having long term disease related problems. Participants can expect to be in this study for up to 24 months and will be followed on this study fir at least 5 years.

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

Evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with the THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL SMARTTOUCH® Catheters for Pulmonary Vein Isolation (PVI) (SURPOINT COA) Save

Date Added
December 11th, 2018
PRO Number
Pro00083402
Researcher
Michael Field

List of Studies

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Keywords
Cardiovascular
Summary

This study is for people who have Paroxysmal Atrial Fibrillation (PAF) and are undergoing an ablation. Atrial fibrillation (AFib) is a type of irregular heartbeat. If you have it, your doctor will classify yours by the reason for it and on how long it lasts. When your heartbeat returns to normal within 7 days, on its own or with treatment, it's known as paroxysmal atrial fibrillation. The purpose of this study is to provide additional information about the safety and effectiveness of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with a THERMOCOOL SMARTTOUCH® SF (STSF) and THERMOCOOL SMARTTOUCH® (ST) catheter. THERMOCOOL SMARTTOUCH® family of catheters have been approved for the treatment of PAF for people that have unsuccessfully tried antiarrhythmic drug treatment (medication used to correct irregular heart rhythm), due to drug intolerance/side-effects or ineffectiveness of the drugs in preventing PAF. Participation in the study will last approximately 12 months after the ablation procedure. There will be a 7-day phone call and study visits at 1 month, 3-month, 6-month, and 12-months after the ablation procedure to monitor the participant's health and arrhythmia status

Institution
MUSC
Recruitment Contact
Deborah Everidge
8437922244
adamsde@musc.edu

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