A Phase I, First-in-Human, Dose Escalation Trial of MSC2363318A, a Dual p70S6K/Akt Inhibitor, in Subjects With Advanced Malignancies Save

Date Added
March 14th, 2017
PRO Number
Pro00060912
Researcher
Sara Giordano
Keywords
Cancer, Men's Health, Women's Health
Summary

MSC2363318A is an investigational drug that is being evaluated for the treatment of subjects with advanced malignancies. Investigational means that it has not been approved by the Food and Drug Administration (FDA), and is still being tested for safety and effectiveness. This study will be divided into 2 parts. MUSC will participate in Part 2. The investigational drug will be given as a monotherapy, in combination with Tamoxifen (an FDA approved drug) and will be given in combination with Trastuzumab (also an FDA approved drug). The study is sponsored by EMD Serono. The investigator in charge of this study is Dr. Sara Giordano. The study is being done at 12 sites nationally. Approximately 64 people will take part, and 5 will take part at MUSC. In order to be eligible, subjects must be older than 18, have advanced maliginancies and specific genetic mutations.
The duration of the study will depend on how the subjects cancer responds to the medication and how it is tolerated.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8438137372
hcc-clinical-trials@musc.edu

Phase I Study of C6 Ceramide NanoLiposome in Patients with Advanced Solid Tumors Save

Date Added
February 21st, 2017
PRO Number
Pro00063038
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study is to study the safety and efficacy of the investigational drug, C6 Ceramide NanoLiposome (CNL). Investigational means that it is not approved by the U.S. Food and Drug Administration (FDA). Study subjects are being asked to participate in this study because they have been diagnosed with an advanced solid tumors and their cancer has not responded to standard treatment. Treatment with the study drug has been shown in animal studies to slow the growth of cancers. These effects may result from cancer cell death or inhibition of tumor blood vessel formation triggered directly by the study drug. An investigational new drug application has been filed at US Food and Drug Administration (FDA) and the FDA has allowed the use of the study drug in this study.

The study team will learn how the drug is handled in the subject's body by measuring the levels of the drug in your blood. They study team will also learn if the treatment is slowing or stopping the growth of the subject's tumor. This is the first time study drug will be given to humans.

This is a dose escalation study which means patients who take part in this study will be treated with different doses of the study drug. Each new dose of study drug will be assessed for safety and to see how well patients can tolerate it. If the new dose does not cause severe side effects, a higher dose will be given. This process will continue until the highest dose that can be given to patients with acceptable, manageable, and reversible side effects has been reached.
The study is sponsored by Keystone Nano, INC and is funded by the National Institutes of Health. The investigator in charge of this study at MUSC is Carolyn Britten, MD. The study is being done at 3 sites. Approximately 48 people will take part study-wide and 8 will take part at MUSC.

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

A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability,Pharmacokinetics, Biological and Clinical Activity of MSB0011359C in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications Save

Date Added
January 10th, 2017
PRO Number
Pro00061658
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks.

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

Phase II trial of vosaroxin in combination with infusional cytarabine in patients with untreated AML. Save

Date Added
January 10th, 2017
PRO Number
Pro00060039
Researcher
Robert Stuart
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for adult patients that are suspected to have or were recently diagnosed with acute myeloid leukemia (AML) and have not yet received treatment for AML. The investigational drug in this study is vosaroxin. The participants can expect to be in this study until they have completed both induction therapies. However, after treatment, they will be in follow-up that consists of disease status updates every 3 months indefinitely.

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

A PHASE 1/2A OPEN-LABEL, MULTI-DOSE, MULTI-CENTER ESCALATION AND EXPLORATORY STUDY OF CERDULATINIB (PRT062070) IN PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)/SMALL LYMPHOCYTIC LYMPHOMA (SLL) OR B-CELL OR T-CELL NON-HODGKIN LYMPHOMA (NHL) Save

Date Added
January 10th, 2017
PRO Number
Pro00061324
Researcher
Valeriy Sedov
Keywords
Cancer, Cancer/Leukemia, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with 1 of the following types of cancer : Chronic Lymphocytic Leukemia (CLL), Small-Cell Lymphocytic Lymphoma (SLL), or of Non-Hodgkin Lymphoma (NHL) of which there are 2 mains types: B-Cell NHL or T-Cell NHL. The investigational drug being studied is PRT062070; it is also called ?cerdulatinib.?The primary purpose of Phase 2a of this study is to assess safety and the activity of the study drug in patients who have CLL, SLL, or B-cell NHL, or T-cell NHL. You will take the study drug until you withdraw your agreement to continue to take part in this study, your cancer becomes worse, you have severe side effects, the research study ends, or you have completed dosing with the study drug and all follow-up study visits.

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

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-547 Injection in the Treatment of Adult Female Subjects with Severe Postpartum Depression and Adult Female Subjects with Moderate Postpartum Depression. Save

Date Added
December 13th, 2016
PRO Number
Pro00061434
Researcher
Constance Guille
Keywords
Depression, Drug Studies, Mental Health, Post Partum Depression, Psychiatry, Women's Health
Summary

This a study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female subjects diagnosed with severe and moderate postpartum depression(PPD). The study will consist of an up to 7-day Screening Period, 3-day Treatment Period, and 30-day Follow-up Period. Subjects must remain as inpatient during the study Treatment Period, which is approximately 60 hours in duration. Assessments and laboratory samples will be collected during the Treatment Period and the Follow-up Period.

Institution
MUSC
Recruitment Contact
Edie Douglas
843-792-0403
douglaed@musc.edu

A Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallel-group, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del-CFTR Mutation Save

Date Added
November 22nd, 2016
PRO Number
Pro00059262
Researcher
Jennifer Hucks
Keywords
Men's Health, Pulmonary, Women's Health
Summary

The purpose of this study is to evaluate the impact of smart adherence technologies for medication monitoring on lumacaftor/ivacaftor (LUM/IVA) adherence rates among subjects 16 years of age and older with CF who are homozygous for the F508del-CFTR mutation, and to collect subject and physician feedback on the use of smart adherence technology to monitor LUM/IVA adherence.

Institution
Palmetto
Recruitment Contact
Jennifer Hucks
8035455453
alisha.henderson@uscmed.sc.edu

Pelvic Floor Disorders Registry - Research Registry (PFDR-R) Save

Date Added
November 21st, 2016
PRO Number
Pro00053947
Researcher
Autumn Edenfield
Keywords
Obstetrics and Gynecology, Urinary, Women's Health
Summary

This is a national database to track patient information and outcomes from surgical and non-surgical treatment for pelvic floor disorders. This will allow for best practices to be identified, and will also track surgeons and institutions in order to recognize clinical centers of excellence. Individual practitioners will be able to track their own data on outcomes for reporting purposes.

Institution
MUSC
Recruitment Contact
Autumn Edenfield
843-876-3292
edenfie@musc.edu

FORWARD 1: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator?s Choice of Chemotherapy in Women with Folate Receptor ??positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer Save

Date Added
November 8th, 2016
PRO Number
Pro00054790
Researcher
Whitney Graybill
Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

This is a Phase 3, open label, randomized study to compare the progression free survival (PFS) of patients randomized to IMGN853 versus selected standard of care chemotherapy.

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

Phase II Investigation of Adjuvant Combined Cisplatin and Radiation with Pembrolizumab in Resected HNSCC Save

Date Added
October 25th, 2016
PRO Number
Pro00053781
Researcher
Paul O'brien
Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for participants who have been diagnosed with head and neck cancer that requires surgery as well as post-operative radiation and possibly cisplatin. The investigational drug in this study is Pembrolizumab. Pembrolizumab is a medication that is currently being tested in multiple cancers. It works by turning on your immune system to recognize and fight your cancer. The purpose of this study is to test the safety and the benefit of adding pembrolizumab to treatment that participants will already be getting for their cancer. Participants can be expected to be in this study for up to 3 years.

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

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