A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation Save

Date Added
May 28th, 2020
PRO Number
Pro00096416
Researcher
John Wrangle

List of Studies

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

This study is for patients who have been diagnosed with solid tumor malignancy with KRAS G12C mutation. The investigational drug used in this study is MRTX849. The purpose of this study is to see if patients with cancer with a KRAS G12C mutation will benefit from treatment with MRTX849, what side effects occur and how often they occur and to see how quickly MRTX849 is absorbed into the blood stream and how fast it is removed by the body. Participants can expect to be in this study for as long as the disease does not get worse.

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

Integrated Early Intervention for Alcohol Use Disorder and Posttraumatic Stress Disorder Following Sexual Assault Save

Date Added
May 5th, 2020
PRO Number
Pro00099114
Researcher
Christine Hahn

List of Studies

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Keywords
Women's Health
Summary

This study is for women who have experienced a sexual assault in the past six weeks and use alcohol. The research involves completing a five week behavioral treatment for stress and alcohol use. Participants will complete surveys during visits. Participants may also be asked to complete brief daily assessments on their smart phones.

Institution
MUSC
Recruitment Contact
Christine Hahn
8437923386
hahnc@musc.edu

SCTR / MUSC COVID-19 Biorepository Save

Date Added
April 16th, 2020
PRO Number
Pro00098961
Researcher
Patrick Flume

List of Studies


Profiles_link
Keywords
Coronavirus, COVID-19, Infectious Diseases, Men's Health, Non-interventional, SARS-CoV-2, Women's Health
Summary

The Medical University of South Carolina (MUSC) is developing a COVID-19 biorepository which will contain blood, urine, and other bodily fluids along with relevant medical information from individuals evaluated, exposed to, or treated for COVID-19. To learn from this pandemic ,and to develop treatments and strategies to better prepare and avert future pandemics we must study the disease and its effects. The clinical specimens in the biorepository will be available for investigators to use for future research. Compensation is provided for participation in this project for eligible participants.

Institution
MUSC
Recruitment Contact
Ricardo Cantu
843-792-8894
coordinator@musc.edu

A Phase I, Open-Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP 3654 in patients with Intermediate-2 or High-Risk Primary or Secondary Myelofibrosis Save

Date Added
February 25th, 2020
PRO Number
Pro00096184
Researcher
Robert Stuart

List of Studies


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

This study is for subjects that have intermediate-2 or high risk, primary or secondary Myelofibrosis for which standard therapy has proven ineffective, for which their body cannot tolerate the standard therapy, or for which there is no standard therapy. This study is testing an "investigational" (not yet FDA approved drug) study drug called TP-3654. The primary purpose of this study is to evaluate the safety of TP-3654 at different doses to find out what effects, if any, it has on people. The subject may remain in the study for up to 1 year. They may receive additional treatment beyond 1 year if they are tolerating and showing benefit from the treatment.

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

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial of DS-8201a, An Anti-HER2-Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HRpositive, HER2-Low Expressing, Unresectable and/or Metastatic Breast Cancer Subjects Save

Date Added
February 25th, 2020
PRO Number
Pro00090546
Researcher
Frank Brescia

List of Studies


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

You are being invited to take part in this research study, because you have a certain type of breast cancer called HER2 (Human Epidermal Growth Factor Receptor 2)-low expressing breast cancer that has spread and/or cannot be completely removed by surgery. The main purpose of this study is to gather information about an experimental drug, DS-8201 a, that may help to treat your disease, as well as, compare it to other standard or "comparator" treatments.

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

Investigating Reward and Affective Neurocircuitry as a Link between Maternal Co-Occurring Substance Use Disorders/Posttraumatic Stress Disorder and Adverse Family Outcomes Save

Date Added
February 18th, 2020
PRO Number
Pro00091359
Researcher
Kathleen Crum

List of Studies

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Keywords
Adolescents, Alcohol, Children's Health, Mental Health, Non-interventional, Psychiatry, Smoking, Stress Disorders, Substance Use, Women's Health
Summary

The project will study how substance abuse and traumatic events are related to how mothers and children respond to rewards, and how they interact with each other. Participating mothers and children will complete tasks in an MRI scanner, questionnaires, and a social behavior task.

Institution
MUSC
Recruitment Contact
Kathleen Crum
843-792-7709
crumk@musc.edu

Initial Intervention Efficacy, Cortisol, and Oxytocin among Pregnant Women with PTSD Save

Date Added
February 11th, 2020
PRO Number
Pro00096405
Researcher
Mary Shapiro

List of Studies

Keywords
Anxiety, Depression, Pregnancy, Women's Health
Summary

The current study aims to adapt and test a brief computer-assisted intervention for pregnant women with elevated posttraumatic stress symptoms. Twenty pregnant women in their first trimester will be invited to participate in the study if they endorse elevated posttraumatic stress symptoms. Along with self-report measures, hormones will be measured at baseline, one month post-intervention, three months post-intervention, and post-delivery. In addition, women will receive a psychoeducation + skills intervention during their first trimester and women will be offered a "booster session" intervention following delivery to enhance utilization of skills during a critical period for maternal mental and physical health outcomes.

Institution
MUSC
Recruitment Contact
Mary Shapiro
843-792-0259
shapimar@musc.edu

Phase III Randomized Study of Crenolanib versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects with FLT3 Mutated Acute Myeloid Leukemia Save

Date Added
February 6th, 2020
PRO Number
Pro00094221
Researcher
Robert Stuart

List of Studies


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

This study is for subjects that are newly diagnosed with acute myeloid leukemia with FLT3 mutations. The investigation drug in this study is crenolanib. The purpose of this study is to compare the efficacy an investigational drug called crenolanib (also referred to as study drug in this consent) with midostaurin (RYDAPT®) which has been approved for treatment of newly diagnosed acute myeloid leukemia patients with FLT3 mutations. The estimated average time that a subject will receive study drug on this study is about 12 months. The subject will take study drug as long as there is clinical benefit (that is their leukemia does not progress) and they are able to tolerate the study drug.

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

A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy alone versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post-Surgery Therapy with Nivolumab or Nivolumab and BMS-986205 in Participants with Muscle-Invasive Bladder Cancer Save

Date Added
February 5th, 2020
PRO Number
Pro00092528
Researcher
Theodore Gourdin

List of Studies

Silhouette
Keywords
Cancer, Cancer/Lymphoma, Men's Health, Women's Health
Summary

This study is for patient that have been diagnosed with muscle-invasive bladder cancer. The investigational drug in this study is Nivolumab and other chemotherapy treatments is given by intravenous (IV) infusion and the BMS-986205 is given in pill form.The purpose of this study is to test the effectiveness (how well the drug works), safety, and side effects of the experimental drug called BMS-986205, when BMS-986205 is added to another cancer medicine called nivolumab plus chemotherapy for subjects who have bladder cancer that has grown into the muscle wall of the bladder.

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

Open Pilot Trial of an Integrated Intervention for Substance Use and Posttraumatic Stress Following Sexual Assault Save

Date Added
February 4th, 2020
PRO Number
Pro00096311
Researcher
Christine Hahn

List of Studies

Silhouette
Keywords
Women's Health
Summary

This study is for women who have experienced a sexual assault in the past six weeks and use alcohol or other substances. The research involves completing a five to six week behavioral treatment for stress and substance use. Participants will complete an a visit before and after the treatment to complete assessments.

Institution
MUSC
Recruitment Contact
Christine Hahn
8437923386
hahnc@musc.edu

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