Phase 1/2 Study of ASP2215 (Gilteritinib) Combined with Atezolizumab in Patients with Relapsed or Treatment Refractory FLT3 Mutated Acute Myeloid Leukemia (AML) Save

Date Added
June 11th, 2019
PRO Number
Pro00088311
Researcher
Robert Stuart

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

This study is for subjects that have been diagnosed with AML, with a mutation, or change, in the FLT3 gene. The investigational drug in this study is gilteritinib (ASP2215). The purpose of this research study is see if a medicine called gilteritinib (ASP2215) given in combination with atezolizumab is both effective and safe as a treatment for AML patients with a mutation, or change, in the FLT3 gene. Participants can expect to be in this study for roughly 2 years.

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

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large b-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release Save

Date Added
May 28th, 2019
PRO Number
Pro00088512
Researcher
Brian Hess

List of Studies

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

This study is for patients who have been diagnosed with B-cell acute lymphoblastic leukemia (ALL) or large B-cell lymphomas. The investigational drug in this study is CTL019 (Tisagenlecleucel). The purpose of this study is to provide the investigational drug as a possible cancer treatment that would otherwise be unavailable. Patients can expect to be in this study for up to 3 months and in follow up for 15 years.

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

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients with Immunoglobulin A (IgA) Nephropathy (Artemis-IGAN) Save

Date Added
May 14th, 2019
PRO Number
Pro00083397
Researcher
Anand Achanti

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Keywords
Drug Studies, Kidney
Summary

This study will use a new investigational study drug called OMS721 in people with Immunoglobulin A (IgA) Nephropathy. OMS721 is an antibody, which is a type of protein that can bind to substances in the body. OMS721 is being studied because it blocks a key enzyme (a protein that causes specific chemical changes in the body) in the blood that may be responsible for causing the damage in IgA Nephropathy.
The study is approximately 23 visits over a period of 3 years. The study drug is administered via a 30-minute intravenous infusion once a week for 12 weeks. You will then be evaluated to determine your response to the drug and followed-up with regularly. Possible re-treatment is determined by the study doctor.

Institution
MUSC
Recruitment Contact
Kellean Van Cleef
843-792-8166
vancleef@musc.edu

A Phase 2 Randomized, Multicenter, Double-blind, Vehicle-controlled, 12-Week, Safety, Efficacy, and Systemic Exposure Study followed by a 12-Week Open-label Extension of Trifarotene (CD5789) Cream HE1 in Adults and Adolescents with Autosomal Recessive Ichthyosis with Lamellar Scale Save

Date Added
April 23rd, 2019
PRO Number
Pro00086734
Researcher
Lara Wine lee

List of Studies

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Keywords
Drug Studies, Skin
Summary

This is a multi-center study of the safety and effectiveness of an experimental study drug in treatment of subjects diagnosed with moderate to severe lamellar ichthyosis (LI). The investigational cream will be applied to the surface of the skin in an effort to reduce LI symptoms such as dry and cracked skin. Participation in the study will last 12 weeks (approximately 6 visits) with the option to continue for another 12 weeks (approximately 5 visits) for a total study duration of up to 24 weeks in total. Compensation may be provided.

Institution
MUSC
Recruitment Contact
Abby Powell
843-792-6690
powab@musc.edu

COMT inhibition as a potential therapeutic target among individuals with comorbid Alcohol Use Disorder and Attention-Deficit/Hyperactivity Disorder Save

Date Added
April 2nd, 2019
PRO Number
Pro00086929
Researcher
Joseph Schacht

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Keywords
ADD/ADHD, Alcohol, Drug Studies, Psychiatry
Summary

The purpose of this study is to evaluate the effects of an FDA-approved medication called tolcapone in people who have both Alcohol Use Disorder (AUD) and Attention-Deficit/Hyperactivity Disorder (ADHD). The study involves seven visits over a three to four week period, including an assessment visit and two eight-day medication periods during which participants will be assigned to take, in a double-blinded fashion, both tolcapone and a placebo (three visits during each period). During two of these visits, participants will undergo a one-hour MRI scan. Participants must not be seeking treatment for AUD or ADHD and must not be currently taking any psychotropic medications, including stimulant medications for ADHD. Compensation is available for qualified participants.

Institution
MUSC
Recruitment Contact
Zoe Brasher
(843) 792-7588
brasherz@musc.edu

A Randomized, Phase II Study of Ficlatuzumab with or without Cetuximab in Patients with Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Save

Date Added
March 12th, 2019
PRO Number
Pro00085004
Researcher
John Kaczmar

List of Studies

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Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with Head and Neck Squamous Cell Carcinoma (HNSCC). The investigational drug used in this study is Ficlatuzumab. The main goals of this research study is to study the safety and effectiveness of Ficlatuzumab with or without Cetuximab, to determine which strategy will be more effective, as well as to learn the potential side effects of Ficlatuzumab alone or in combination with Cetuximab. It is unknown exactly how long participants can expect to be in the study. Subjects will receive treatment until the drug is no longer effective on their cancer.

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

A pilot human laboratory study of cannabidiol in Alcohol Use Disorder Save

Date Added
March 5th, 2019
PRO Number
Pro00086168
Researcher
Joseph Schacht

List of Studies


Profiles_link
Keywords
Alcohol, Drug Studies, Psychiatry
Summary

This study will examine the effects of Epidiolex among adults who drink alcohol heavily but who are not seeking treatment for their alcohol use. Epidiolex is an FDA-approved formulation of cannabidiol, the primary non-psychoactive constituent of cannabis. Participants in the study will be randomly assigned to take Epidiolex or placebo for 8 days. There are 3 study visits, including a day-long visit in the laboratory.

Institution
MUSC
Recruitment Contact
Katy Fuqua
(843) 792-1452
fuquama@musc.edu

An Exploratory Investigation Utilizing Repetitive Transcranial Magnetic Stimulation (rTMS) as a Tool to Decrease Pain and Improve Functioning in Veterans with Opioid Use Disorder Save

Date Added
February 5th, 2019
PRO Number
Pro00084970
Researcher
Aimee Mc Rae

List of Studies


Profiles_link
Keywords
Drug Studies, Substance Use
Summary

The purpose of this study is to determine if repetitive transcranial magnetic stimulation (rTMS) reduces opiate craving and pain in Veterans who are receiving treatment for opioid use disorder. The study will last approximately three months. There will be a screening visit to determine eligibility, followed by the treatment phase during which participants will receive six sessions of rTMS a day for three non-consecutive days. This period may take up to three weeks. There are follow up visits at one week, four weeks and three months after the treatment phase has ended.
During rTMS, focused magnetic waves are directed at a part of the brain that is important in pain, and craving, to increase its activity. If you participate, you will receive six sessions of either active rTMS, or placebo rTMS, each day for three days (18 total sessions). Each session lasts 15 minutes. People typically do not have side effects with rTMS, though they initially may find it mildly painful at the application site. About 1 out of every 20 people who get rTMS have mild headaches after sessions that are typically relieved with over-the-counter medicines. A few people who have had rTMS have had seizures, though the chance of this happening is very small.

Institution
MUSC
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu

A Phase 1/2 Study for the Safety, Efficacy, Pharmacokinetic and Pharmacodynamics Evaluation of SAR439859, Administered Orally as Monotherapy, Then in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor-positive Advanced Breast Cancer Save

Date Added
January 22nd, 2019
PRO Number
Pro00084301
Researcher
Antonio Giordano

List of Studies

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Keywords
Cancer/Breast, Drug Studies, Women's Health
Summary

This is an open-label, nonrandomized, dose escalation and dose expansion, safety, efficacy, PK and PD evaluation study of SAR439859 administered orally as monotherapy, then in combination with palbociclib. The study will last approximately 26 months, and participation in the study may last 4 to 8 weeks or longer. The length of participation in this study will depend on how well subjects tolerate the study drug and the condition of their disease.

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

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess the Efficacy and Safety of Apremilast (CC 10004) in Pediatric Subjects from 6 through 17 Years with Moderate to Severe Plaque Psoriasis Save

Date Added
January 22nd, 2019
PRO Number
Pro00084118
Researcher
Lara Wine lee

List of Studies

Silhouette
Keywords
Drug Studies, Pediatrics, Skin
Summary

The purpose of this study is to test and compare the effects of an investigational (being tested) drug called apremilast to placebo in pediatric plaque psoriasis.
Participants who are determined to be eligible to participate will be assigned by chance (or randomized) to treatment with apermilast or placebo. At Week 16, participants will receive apremilast regardless of treatment group. Study and safety assessments, including questionnaires and blood draws, will be completed at study visits. The maximum amount of time participants will be in the study is 71 weeks (at least 19 visits).

Institution
MUSC
Recruitment Contact
Reshil-Marie Dukes
843-792-0387
dukesre@musc.edu

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