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
Sara Giordano

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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


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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

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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

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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 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

ELACESTRANT MONOTHERAPY VS. STANDARD OF CARE FOR THE TREATMENT OF PATIENTS WITH ER+/HER2- ADVANCED BREAST CANCER FOLLOWING CDK4/6 INHIBITOR THERAPY: A PHASE 3 RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER TRIAL(EMERALD) Save

Date Added
January 30th, 2020
PRO Number
Pro00094418
Researcher
Antonio Giordano

List of Studies

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

Patients are being asked to take part in this research study because they have estrogen receptor positive (ER+), human epidermal growth factor negative (HER2-) advanced breast cancer. Researchers want to find out if an investigational drug called elacestrant, also known as RAD1901, can help people with their type of advanced breast cancer.

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

ATHN 9: A Natural History Cohort Study of the Safety, Effectiveness, and Practice of Treatment for People With Severe Von Willebrand Disease (VWD) Save

Date Added
January 27th, 2020
PRO Number
Pro00092790
Researcher
Stephanie Ambrose

List of Studies

Keywords
Adolescents, Blood Disorders, Children's Health, Circulation, Dental, Genetics, Infant, Joint, Men's Health, Minorities, Muscle, Non-interventional, Nose, Obstetrics and Gynecology, Pain, Pediatrics, Periodontal Disease, Rare Diseases, Rheumatoid, Surgery, Women's Health
Summary

ATHN 9 is a natural history study to assess the safety of various Von Willebrand Factor (VWF) regimens for different indications (on-demand, surgery and prophylaxis) in adult and pediatric participants with clinically severe congenital VWD.

Institution
Palmetto
Recruitment Contact
Shannon Cearley
803-434-4088
shannon.cearley@prismahealth.org

A Phase 1b trial of CPX-351 Lower Intensity Therapy (LIT) plus Venetoclax as First Line Treatment for Subjects with AML who are Unfit for Intensive Chemotherapy Save

Date Added
January 14th, 2020
PRO Number
Pro00094444
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 with newly diagnosed Acute Myeloid Leukemia (AML). The investigational drug in this study is CPX-351(marketed as Vyxeos). The purpose of this research study is to find out whether a reduced dosing of CPX-351, given in combination with Venetoclax, is safe and effective when given to subjects with newly diagnosed AML who cannot tolerate intensive chemotherapy due to age or other health conditions. Subjects can expect to be in this study for approximately 1 year.

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

A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients with Relapsed or Refractory Hodgkin Lymphoma Save

Date Added
December 10th, 2019
PRO Number
Pro00095145
Researcher
Brian Hess

List of Studies

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

This study is for adult male and female subjects that have been diagnosed with a blood cancer called Hodgkin Lymphoma (HL) that has gotten worse or come back after treatment with available therapies known to provide clinical benefit. The investigational drug in this study is Camidanlumab Tesirine (Cami, ADCT-301) and will be administered intravenously. The purpose of this Phase 2 study is to evaluate the effectiveness and safety of the investigational drug Cami (ADCT-301) in subjects with HL that has gotten worse or come back after treatment. Participants can expect to be in this study for a total of 4 years; 1 year in treatment (Seen 4 times per month to begin with and then every 6-9 weeks at MUSC, while you remain on treatment) and 3 years in follow up.

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

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