A Randomized Phase II Study of INC280 (Capmatinib) plus Osimertinib with or without Ramucirumab in Participants with EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

Date Added
July 19th, 2023
PRO Number
Pro00130230
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer/Lung
Summary

This study is for patients who have advanced non-small cell lung cancer who in addition to the EGFR gene change (mutation) that was previously found in their tumor, testing found that their tumor also now has MET gene changes. The study is checking to see if a combination of 3 targeted drugs work together to lower the chance of lung cancer growing or spreading.

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

Randomized Phase II/III Trial of First Line Platinum/Etoposide with or without Atezolizumab (NSC #783608) in Patients with Advanced or Metastatic Poorly Differentiated Extrapulmonary Neuroendocrine Carcinomas (NEC)

Date Added
July 30th, 2023
PRO Number
Pro00129939
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal, Cancer/Genitourinary
Summary

This study is for patients with neuroendocrine carcinoma (NEC) originating outside of the lung. This study is being done to see if the combination of atezolizumab, an immunotherapy drug, with a platinum drug (cisplatin or carboplatin) and etoposide better or worse than a platinum drug and etoposide for patients with advance or metastatic neuroendocrine carcinoma originating outside the lung

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

Comparing the Effects of Augmented Doses of Nicotine Replacement Therapy on Quitting Cigarettes and E-cigarettes

Date Added
September 19th, 2023
PRO Number
Pro00130184
Researcher
Amanda Palmer

List of Studies

Keywords
Smoking
Summary

Many people smoke cigarettes and use e-cigarettes, and have a hard time stopping. Nicotine replacement therapy medications, such as nicotine patches and lozenges, have been shown to help people quit e-cigarette use. The purpose of the present study is to see how well nicotine patches and lozenges help people quit both smoking and vaping, and to determine if higher doses of the medication work best.

Institution
MUSC
Recruitment Contact
Rachel Christian
(843) 737-1516
chrisrac@musc.edu

A RANDOMIZED PHASE II TRIAL OF NIVOLUMAB AND IPILIMUMAB COMPARED TO NIVOLUMAB MONOTHERAPY IN PATIENTS WITH DEFICIENT MISMATCH REPAIR SYSTEM RECURRENT ENDOMETRIAL CARCINOMA

Date Added
November 6th, 2023
PRO Number
Pro00131158
Researcher
Brian Orr

List of Studies

Keywords
Cancer/Gynecological
Summary

This study is for subjects with endometrial cancer has spread to other parts of your body and/or has not responded to previous treatment(s). The study is being done to see if combining two immunotherapy drugs, nivolumab and ipilimumab, more effective in shrinking their cancer and preventing its growth than single drug immunotherapy with nivolumab alone. The subject can expect to be in this study for up to 24 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in Subjects With Parkinson's Disease With a Pathogenic Variant in the Glucocerebrosidase (GBA1) Gene

Date Added
November 14th, 2023
PRO Number
Pro00127605
Researcher
Federico Rodriguez-Porcel

List of Studies


Keywords
Parkinsons
Summary

The purpose of this clinical trial is to evaluate the safety and efficacy of BIA-28-6156 in subjects with Parkinson's Disease (PD). BIA -28-6156 is an investigational drug meaning that its safety, effects and how it works are still being studied. This is a randomized (assigned by chance), placebo-controlled study, which means that some participants will receive a fake treatment (placebo) while others get the real treatment. The placebo treatment looks like the BIA-28-6156 medications but doesn't contain any active ingredient. The medication is in a pill form and will be administered orally. This research is also double blind, meaning that neither the participants nor the researcher will know which treatment they will be receiving. In Part A of this study, participants will be asked to give a blood sample for a genetic screening test. If genetic testing in part A indicates the person can participate, they may be asked to volunteer for part B. Duration of Part B is about 87 weeks, this includes 5 weeks for screening, 78 weeks for the double-blind treatment period, and 4 weeks for follow up. There are at least 11 visits in total in 20 months (9 clinic visits, 2 remote phone/video visits); this does not include unscheduled visits. During visits, participants should anticipate tests including electrocardiograms (ECGs), vitals measurements (including temperature, blood pressure, and heart rate), and a physical/neurological examination. Some of the risks includes fatigue, headache, drowsiness, muscle aches and possible worsening of PD symptoms. As for benefits, participants who receives the BIA drug may see their PD progression slowing.

Institution
MUSC
Recruitment Contact
Sandra Wilson
843-792-4616
wilsosan@musc.edu

A Multicenter, Randomized, Double-Blind, Parallel-Group, Controlled, 16-week Study to Evaluate the Efficacy and Safety of a Digital Therapeutic (CT-155) as an Adjunct to Standard-of-Care Antipsychotic Therapy in Adult and Late Adolescent Participants with Experiential Negative Symptoms of Schizophrenia

Date Added
November 29th, 2023
PRO Number
Pro00132018
Researcher
Mark Hamner

List of Studies


Keywords
Complementary Medicine, Mental Health
Summary

The Convoke study is looking for people diagnosed with schizophrenia who are are at least 18 years of age; have a primary diagnosis of schizophrenia; have been on a stable dose of antipsychotic medication for at least 12 weeks
before the study treatment period; and own a smartphone compatible with Android 10 or greater, or iOS 14 or greater. The Convoke Study will look at 2 mobile applications (apps) to see if they can support people with moderate to severe negative schizophrenia symptoms. These apps are investigational prescription digital therapeutics (PDTs) that are downloaded onto your smartphone. This study will see if an app can be part of a schizophrenia treatment plan.

Institution
MUSC
Recruitment Contact
Della MacNicholas
843-792-8385
macnichd@musc.edu

A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (bexotegrast) for the treatment of idiopathic pulmonary fibrosis (BEACON)

Date Added
December 19th, 2023
PRO Number
Pro00132461
Researcher
Timothy Whelan

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

This is a randomized, double-blind, dose-ranging, placebo-controlled study to see how effectively and how safely two different doses of bexotegrast (160 and 320 mg) can be taken every day for 52 weeks (about 12 months) by subjects with IPF (Idiopathic Pulmonary Fibrosis) who are taking or not taking background therapy (other drugs for IPF include nintedanib or pirfenidone). The study is designed to test the study drug in subjects who are taking or not taking background therapy and will include about 80 subjects who are not taking background therapy at study entry. Subjects who are not taking background therapy at study entry will be allowed to start it at any time during the study. The study will consist of an up to 28-day Screening Period, a 52-week Treatment Period, and a 14-day Safety Follow-up Period. Participants will undergo an end-of-study visit at the end of the Safety Follow-up Period.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Prospective Comparison of Superior Laryngeal Nerve Block with Intramuscular Sternocleidomastoid Steroid Administration for the Treatment of Refractory Unexplained Cough

Date Added
January 2nd, 2024
PRO Number
Pro00132573
Researcher
Lauren Howser

List of Studies

Keywords
Throat
Summary

The goal of this research study is to find out if intramuscular sternocleidomastoid (SCM) steroid injections work to reduce cough when compared to superior laryngeal nerve (SLN) steroid injection. Study patients will be randomly assigned to receive injections to numb the sensation within the voice box in one of two possible locations, either a traditional voice box injection or an injection into the neck muscle (a muscle in the neck near the voice box). The injections are composed of a numbing medication (lidocaine) and a medication that helps the numbing medication work longer (steroid). The outcomes studied will include if the treatments help to minimize chronic cough and associated symptoms. By better understanding if this treatment helps improve chronic cough, an additional treatment option could help patients with chronic cough. Voice box injections are usually only performed by fellowship trained laryngologists (an extra specialized year of training after ENT training). However, if neck muscle injections are found to be equivalent in treating chronic cough, general ENT doctors could likely provide this treatment to their patients without the need to see a specialized voice box doctor.

Institution
MUSC
Recruitment Contact
Kirsten Meenan
843-792-6755
meenan@musc.edu

A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects with Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (M18-868)

Date Added
January 3rd, 2024
PRO Number
Pro00131334
Researcher
Mariam Alexander

List of Studies

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

This research is all about investigating a potential treatment for a specific type of advanced lung cancer. The cancer cells have a protein called c-Met that's acting a bit too excited, driving the cancer to spread and resist treatment. This study focuses on two treatments: one is called Telisotuzumab Vedotin (ABBV-399), which is a smart combination of an antibody and a drug that can stop this protein's activity. The other treatment is called Docetaxel. The researchers have already found in smaller studies that Telisotuzumab Vedotin could be promising for this type of cancer, especially in patients whose previous treatments didn't work well. Now they want to see if it can really make a difference in the long run. They'll be comparing Telisotuzumab Vedotin and Docetaxel to figure out which one is better at helping patients live longer without their cancer getting worse. In this study, participants will be randomly divided into two groups, like flipping a coin. One group will get a new medicine called telisotuzumab vedotin through a vein in their arm every two weeks. The other group will receive a treatment called docetaxel through a vein every three weeks. People in both groups will keep getting their assigned treatment until their doctors say it's time to stop based on certain criteria. Throughout the study, participants will have scans like X-rays or MRIs to see how their tumors are doing. These scans will happen at the beginning and then every few weeks for the first year, and less often as time goes on.Even if someone stops their treatment for a reason other than their cancer getting worse on these scans, the researchers will keep track of them until their cancer gets worse or until they decide they don't want to be in the study anymore.The whole study is expected to last around 38 months, which is a little over 3 years. They'll keep following up with the participants, either by talking to them, checking their medical records, or other appropriate methods, until the participants decide to leave the study or pass away. This study is a big step towards finding better options for people battling this tough form of lung cancer.

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

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF); LEVEL: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

Date Added
January 9th, 2024
PRO Number
Pro00132012
Researcher
Daniel Silverman

List of Studies

Keywords
Cardiovascular, Heart
Summary

The purpose of the study is to evaluate the safety and how well the medication levosimenden works versus placebo in treating Pulmonary Hypertension and Heart Failure with a Preserved Ejection Fraction measured by a 6 minute walk. This is a condition where the lower left chamber (left ventricle) of the heart is not able to fill properly with blood during the filling phase and the amount of blood pumped out to the body is below normal. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Levosimendan is a drug that has been FDA-approved for intravenous (IV) delivery to your body. This study aims to determine if the tablet form of the drug is as effective as the IV route. Tablets are much more attainable for patients to manage their heart failure from home, rather than going to an infusion clinic for treatments. Participation in this study will last approximately 12 weeks with the option to continue to the stage 2 phase of the study. If the stage 2 phase is selected as well, participation will last approximately 26 months or a little over 2 years. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, echocardiogram, and 6 minute hall walks.

Participants will be randomized to either the treatment group (and receive the medication) or the control group (receive an inactive medication). Subjects will have a 50:50 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned.

Institution
MUSC
Recruitment Contact
Shaquanda Ross-Simmons
843-876-5783
shr37@musc.edu



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