A Novel Harm Reduction Approach for Oncology Outpatients who Smoke and Refuse Traditional Tobacco Treatment

Date Added
August 20th, 2024
PRO Number
Pro00138162
Researcher
Alana Rojewski

List of Studies


Keywords
Cancer, Smoking
Summary

For patients in cancer care, quitting smoking is critical, but a significant portion of patients in cancer care refuse all components of tobacco treatment, even when offered proactively and free of charge. The proposed clinical trial will assess one harm reduction intervention, switching completely from cigarettes to e-cigarettes, among oncology outpatients who smoke and refuse traditional tobacco treatment.

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

A Multicenter, Open-Label Phase 1/1B Dose-Finding, Safety, and Pharmacokinetic Study of MBRC-101, an Anti-EPHA5 Monomethyl Auristatin E (MMAE) Antibody Drug Conjugate, in Advanced Refractory Solid Tumors

Date Added
August 20th, 2024
PRO Number
Pro00135442
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Drug Studies
Summary

This is a first-in-human (FIH), open label Phase 1/1b study in patients
with advanced metastatic solid tumors refractory to standard treatment.
Phase 1 will identify potential optimal biologically relevant doses
(OBRD) and the MTD of MBRC-101 at 1 or more dosing regimens.
Phase 1b will evaluate the safety and preliminary clinical activity of
MBRC-101 at potential OBRDs. Phase 1 and Phase 1b will both
characterize single and multiple-dose PK profiles and evaluate incidence
and persistence of anti-MBRC-101 Ab formation.

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

A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy with Pelvic Lymph Node Dissection (Pathfinder)

Date Added
August 16th, 2024
PRO Number
Pro00135932
Researcher
Robert Grubb

List of Studies


Keywords
Bladder, Cancer, Cancer/Genitourinary
Summary

The purpose of this research study is to see how effective the use of copper Cu 64 PSMA I&T Injection is in imaging prostate cancer tumors for staging of men with newly diagnosed intermediate or high risk prostate cancer who are planned to have radical prostatectomy with pelvic lymph node dissection. Three hundred twenty-three (323) patients are planned for enrollment in this Phase 3 study, at approximately 60 sites in the U.S. and Europe. Copper Cu 64 PSMA I&T Injection is an investigational imaging agent, given to you via IV injection, that may make tumors from prostate cancer show up better during a nuclear medicine imaging scan. The imaging scan is a type of nuclear medicine imaging test, which means it uses a radioactive drug and a special camera to create pictures of your tumor(s). Copper Cu 64 PSMA I&T Injection is investigational in the United States which means that the U.S. Food and Drug Administration (FDA) has not yet approved it.

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

A First-in-Human, Phase 1/2, Open-Label, Multi-Center, Dose Escalation, Dose-Optimization, and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of PARP1 Selective Inhibitor, IMP1734, in Patients with Advanced Solid Tumors

Date Added
August 14th, 2024
PRO Number
Pro00136726
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to test IMP1734 in humans for the first time and to assess the safety, tolerability, PK, PD, and anti-tumor activity of IMP1734 in patients with advanced solid tumors. The study will be conducted in 3 parts. Part 1 (dose escalation): Dose-escalation phase where the MTD (or MAD) will be
determined and safety, tolerability, PK, PD, and preliminary anti-tumor activity of IMP1734. Part 2 (dose optimization): Further evaluation of the safety, tolerability, PK, PD, and preliminary anti-tumor activity of selected dose levels of IMP1734. Part 3 (dose expansion): Efficacy, safety, and PK of IMP1734 with the dose(s) selected based on accumulated data will be assessed in either patients who have not received prior therapy with a PARPi containing treatment.

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

The Global Paradise® System US Post Approval Study (US GPS)

Date Added
August 13th, 2024
PRO Number
Pro00138696
Researcher
Thomas Todoran

List of Studies


Keywords
Hypertension/ High Blood Pressure
Summary

This study will enroll two groups of participants. The first group are those who participated in the RADIANCE CAP study, so have already undergone the renal denervation procedure. Those participants can enroll in this post approval study which will entail yearly follow up visits or telephone calls, blood pressure monitoring and questionnaires. The second group of participants are those scheduled to undergo a procedure called renal denervation for the treatment of high blood pressure that has not responded adequately to medications and lifestyle changes. Renal denervation is a procedure which uses a catheter (thin hollow tube) placed in the renal arteries (blood vessels that go to the kidneys) to deliver ultrasound energy. This energy will heat up a small area of tissue around the renal arteries to disable nerves that are surrounding the blood vessels as a way to help reduce blood pressure. Study visits include screening, procedure, discharge, months 1, 3, 6 and 12 then yearly for up to 5 years. Study procedures for this group includes blood work and urine studies, blood pressure monitoring, questionnaires, a follow up ultrasound of your kidneys and the blood vessels around the kidneys. Study related risks include loss of confidentiality, blood draw risks and unknown risks.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843-876-5009
awkar@musc.edu

A phase 2, adaptive, double-blinded, placebo controlled, randomized, multi-center trial to evaluate the efficacy, safety and tolerability of intracoronary infusion of AB-1002 in adult subjects with New York Heart Association (NYHA) Class III heart failure and non-ischemic cardiomyopathy (GenePHIT)

Date Added
August 13th, 2024
PRO Number
Pro00138528
Researcher
Adrian Van Bakel

List of Studies


Keywords
Cardiovascular, Genetics, Heart
Summary

This study is evaluating the safety and effectiveness of the experimental treatment named AB-1002. The purpose of this study is to look at the safety and feasibility of delivery of adeno-associated virus (AAV) through the coronary arteries into the heart in participants with heart failure and non-ischemic cardiomyopathy. An experimental treatment is another option for care for your disease that is still being tested and is not yet approved by the Food and Drug Administration (FDA).

Participation in this study is expected to last one year and include up to 18 visits. Study related procedures include the following heart related testing: study drug infusion, electrocardiograms (ECG), a test to show the heart's electrical activity, echocardiogram (Echo), a test that uses ultrasound to capture moving images of the heart, cardiopulmonary stress test, sample collection including blood, urine, tissue, nasal mucus, saliva, semen, and stool, questionnaires, physical exams, and at least an overnight stay in the hospital. You will also need to take medications to suppress your immune system.

There are risks associated with this study. Risks associated with gene therapy include an immune response that may cause inflammation in the liver, heart or other organs. It may damage your red blood cells, cause a low platelet count or cause the formation of small blood clots. There are also risks related to the study procedures including bleeding associated with the heart biopsy, risks related to drawing blood, risks of radiation, and loss of confidentiality. There may be no benefit to you but knowledge gained from this study may benefit others with heart failure and non-ischemic cardiomyopathy in the future.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
8438765783
shr37@musc.edu

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Amyloid Depleter ALXN2220 in Adult Participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

Date Added
August 13th, 2024
PRO Number
Pro00138400
Researcher
Jan Griffin

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart
Summary

This study involves an investigational drug called ALXN2220 for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Investigational means it is not yet approved for commercial use or sale by the Food and Drug Administration (FDA). ALXN2220 is intended to promote the elimination of ATTR deposits leading to symptom improvement.
All participants will be randomized, meaning assigned by chance, to receive ALXN2220 or placebo. A placebo looks like the study drug but contains no active medication. In this study, participants will have a 2 out of 3 chance, like drawing straws, of receiving the study drug and 1 out of 3 chance of receiving placebo. Neither the participants nor the study team or study doctor will know if they are assigned to receive the study drug or placebo. The study drug or placebo will be administered intravenously (IV), meaning into a vein in the arm, every four weeks.
Participation in this study will include a maximum of 56 visits over a maximum of 48 months. Study procedures include collection of vital signs, study drug infusion, physical exams, 12-lead electrocardiography, blood and urine collection, echocardiogram (ultrasound test of the heart), questionnaires, and some optional testing.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

Health Outcomes of Parents with Cystic Fibrosis (HOPe:CF) Aim 2

Date Added
August 13th, 2024
PRO Number
Pro00136818
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

We will follow 146 new parents of children <5 years of age at 18 participating US
adult CF centers to assess the primary outcome of ppFEV1 up to 5 years after
becoming a parent. A prospective approach will capture the immediate and longterm impact of the use of the highly effective CFTR modulator ETI by ~90% of US
adults with CF. By combining objective health measures and participant surveys,
we can comprehensively assess the psychosocial impacts of parenthood and
explore the interplay between the parenting role and physical and mental health.
We anticipate identifying modifiable factors that may ameliorate negative health
impacts of parenthood.

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

A PHASE 3 RANDOMIZED WITHDRAWAL AND DOSE-UP TITRATION, MULTICENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO

Date Added
August 13th, 2024
PRO Number
Pro00135139
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a Phase 3, 52-week, multi-center, double-blind, parallel-group, randomized withdrawal (RW), dose-up titration (DUT) extension study investigating the safety, tolerability, efficacy and durability of response of ritlecitinib (50 mg QD and 100 mg QD) in adult and adolescent (where permitted) participants with nonsegmental vitiligo following their participation in pivotal Study B7981040. The maximum duration of study participation is approximately 14 months, including a screening period up to 25 days, a 52-week treatment period, and a 4-week follow-up period.

Institution
MUSC
Recruitment Contact
Tiffany Vereen
843-792-6882
vereent@musc.edu

A Phase I/Randomized Phase II, Open-Label Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of mFOLFIRINOX With or Without BNT321 as Adjuvant Therapy Following Curative Resection in Patients with Pancreatic Adenocarcinoma

Date Added
August 13th, 2024
PRO Number
Pro00134872
Researcher
Albert Lockhart

List of Studies

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

The purpose of this study is to evaluate investigational treatments (study drug) for pancreatic adenocarcinoma following surgery in order to determine if any of these study treatments improve overall survival as compared to standard treatments. The goal is to determine the optimal dose level, safety, and tolerability for the study drug BNT321 in combination with mFOLFIRINOX. BNT321 is not FDA approved. mFOLFIRINOX is FDA approved by the U.S. Food and Drug Administration (FDA) to treat various cancers but may not be approved for your type of cancer. Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include diarrhea, nausea, vomiting, fatigue, headache, fever, and joint pain. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

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



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