A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Date Added
November 14th, 2023
PRO Number
Pro00127646
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Drug Studies
Summary

This study is enrolling subjects with advanced solid tumors with the TP53 Y220C alteration in cancer cells. This alteration is a mutation of the tumor that can be found through laboratory tests that use a sample of tissue, blood, or other fluids to check for signs of cancer. This study involves research testing the safety, best dose, side effects and timing of the study drug called PC1486. You will take the study drug, PC14586, in the form of a tablet. If assigned to the combination treatment arm (Part 1), you will also be given pembrolizumab as an intravenous (IV) infusion. Pembrolizumab is a type of immunotherapy that is FDA approved to treat your kind of cancer. The study drug PC1486 is not approved by the Food and Drug Administration (FDA). This study drug targets the TP53 Y220C genetic alteration in tumor cells. During the pre-screening portion, participants will provide either archived tissue or a fresh tumor sample to test for the genetic alteration. If the participants show the genetic tumor alteration in the cancer cells, they may be asked to participate in the trial. Treatment arms are groups or subgroups of participants in a clinical trial. This study will have two arms: one studies PC1486 alone and the second arm studies PC1486 in combination with Pembrolizumab against advanced solid tumors. PC14586 is a small molecule (chemical) that is designed to act on the genetic alteration TP53 Y220C in cancer cells to slow the growth of cancer, and it is taken orally. This study involves blood tests, a possible tumor biopsy, CT, and MRI scans. The study will last approximately 6 months of treatment, followed up by a check-up after the first 3 weeks and every 3 months after. Some common risks (observed in greater than 20% of people) include: Nausea, Vomiting, Abnormal liver tests, Abnormal kidney test (possible kidney damage

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

Evaluation of a Choice Drinking Bar-Laboratory Paradigm for Individuals with Bipolar Disorder

Date Added
November 7th, 2023
PRO Number
Pro00131339
Researcher
Will Mellick

List of Studies


Keywords
Alcohol, Mental Health, Substance Use
Summary

This study will evaluate the associations and interactions between bar-lab/naturalistic drinking variables with participant characteristics in individuals with bipolar disorder and alcohol use disorder. This study includes 4 study visits over approximately 1 week. Questionnaires and clinical interview measures will be completed at study visits.

Institution
MUSC
Recruitment Contact
Sara Hix
843-792-0572
hixs@musc.edu

Leveraging Technology to Reduce Disparities and Improve Early Detection of and Timely Care for Postpartum Complications

Date Added
November 7th, 2023
PRO Number
Pro00130902
Researcher
Constance Guille

List of Studies


Keywords
Mental Health, Minorities, Obstetrics and Gynecology, Post Partum Depression, Pregnancy, Psychiatry, Women's Health
Summary

The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 4 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a care coordinator will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.

Institution
MUSC
Recruitment Contact
Ellen Gomez
843-998-5635
gomezel@musc.edu

Leveraging Technology to Reduce Disparities and Improve Early Detection of and Timely Care for Postpartum Complications

Date Added
November 7th, 2023
PRO Number
Pro00130902
Researcher
Constance Guille

List of Studies


Keywords
Mental Health, Minorities, Obstetrics and Gynecology, Post Partum Depression, Pregnancy, Psychiatry, Women's Health
Summary

The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 4 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a care coordinator will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.

Institution
MUSC Health Kershaw Medical Center
Recruitment Contact
Ellen Gomez
843-998-5635
gomezel@musc.edu

Leveraging Technology to Reduce Disparities and Improve Early Detection of and Timely Care for Postpartum Complications

Date Added
November 7th, 2023
PRO Number
Pro00130902
Researcher
Constance Guille

List of Studies


Keywords
Mental Health, Minorities, Obstetrics and Gynecology, Post Partum Depression, Pregnancy, Psychiatry, Women's Health
Summary

The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 4 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a care coordinator will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Ellen Gomez
843-998-5635
gomezel@musc.edu

A Phase 2 Multicenter, Randomized, Double-blind, Placebocontrolled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TTI-101 in Participants with Idiopathic Pulmonary Fibrosis

Date Added
November 6th, 2023
PRO Number
Pro00132082
Researcher
Rachana Krishna

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

This multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical
study is designed to evaluate the safety and tolerability of 3 dose levels of TTI-101 vs placebo in participants with idiopathic pulmonary fibrosis (IPF). a screening period of up to 28 days, 100 participants will be randomly assigned to receive 1 of 3 dose levels of TTI-101 (25 participants per dose level) or matching placebo (25 participants). Enrollment will be stratified by current use of nintedanib. The assigned study drug will be self-administered orally in tablet form twice daily (BID) with a glass of water after a meal. Once randomized, each participant will maintain their current standard of care supportive medications, including cough treatment, medications for symptom relief or quality of life improvements, oxygen therapy where indicated, respiratory physiotherapy, and treatment of comorbidities. Following randomization, all participants will enter the 12-week, double-blind treatment period.

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

Pediatrics Biorepository for Neurosurgery

Date Added
November 1st, 2023
PRO Number
Pro00126218
Researcher
Ramin Eskandari

List of Studies


Keywords
Brain
Summary

The goal of this study proposal is to develop a biorepository which will collect and store central nervous system (CNS) tissue, connective tissue, blood, or cerebral spinal fluid (CSF) for future research. This material will be collected from children with CNS conditions or defects. This will be a very useful resource to scientists who work to develop new approaches to prevent and treat conditions that affect children's brains and nervous systems.

Institution
MUSC
Recruitment Contact
Ramin Eskandari
(843) 876-0444
eskandar@musc.edu

A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections

Date Added
October 31st, 2023
PRO Number
Pro00132920
Researcher
Andrew Goodwin

List of Studies


Keywords
Coronavirus
Summary

The protocol aims to improve standard of care, by ensuring an agile research infrastructure, with an ability to rapidly assess interventions during epidemic transmission of one or more respiratory pathogens adversely affecting public health.

Trials within this protocol can be adaptive, will be randomized, and will have superiority as the primary objective. Comparisons in the trials may be between an unlicensed agent to a blinded placebo plus standard of care (SOC), between an approved off-label agent to a blinded placebo plus SOC, among several active interventions (blinded or non-blinded; i.e., a comparative effectiveness study), or among different treatment strategies.

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

A South Carolina ECHO Pregnancy Cohort

Date Added
October 31st, 2023
PRO Number
Pro00131971
Researcher
Kelly Hunt

List of Studies


Keywords
Children's Health, Environmental Factors, Pregnancy
Summary

The ECHO Cohort is a longitudinal prospective multi-site study aiming to understand how the environment and things that happen early in children's lives - even before they are born - affect their development, health, and well-being. This research program includes many study sites across the United States. ECHO will combine information about 20,000 pregnant participants, more than 50,000 children, and their families. With so many participants from across the country, researchers can answer important childhood health questions.

Institution
MUSC
Recruitment Contact
Erin Alsbrook
7038634359
echosc@musc.edu

Investigate Host Gene Isoforms Contributing to HIV Persistence in Cocaine Users

Date Added
October 26th, 2023
PRO Number
Pro00131297
Researcher
Wei Jiang

List of Studies


Keywords
Drug Studies, HIV / AIDS
Summary

HIV infected cocaine users have uncontrolled viral levels and impaired immunity to control infection compared to HIV infected non-drug users. We ask the questions why cocaine use makes HIV infected cocaine users more sick than other patients. The goal is to improve immunity to control HIV infection in cocaine users. Both uninfected cocaine users and HIV-infected cocaine users are especially needed in this study.

Institution
MUSC
Recruitment Contact
Alicia Hartley
843-792-4100 (Alicia); 843-876-2457 (Wei)
hartleal@musc.edu (Alicia); jianw@musc.edu (Wei)



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