A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer Save

Date Added
March 27th, 2018
PRO Number
Pro00075360
Researcher
Daniel Reuben

List of Studies

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Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies, Pancreas
Summary

This study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer. There is not a set number of clinic visits and subjects can remain on study provided their disease is at least stable for each imaging time point, and if study drugs are sufficiently tolerated

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

A Phase 2, Prospective, Randomized, Open-label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus- Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant Save

Date Added
February 27th, 2018
PRO Number
Pro00072922
Researcher
Michelle Hudspeth

List of Studies


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

This study is for subjects who have been diagnosed with acute leukemia or myelodysplastic syndrome (MDS) and are a candidate for allogeneic hematopoietic stem cell transplant (HSCT). The study is being done to learn if adding defibrotide to the standard medicines for prevention of acute Graft-versus-Host Disease (aGvHD), which is called immunoprophylaxis, will help to prevent aGvHD better than using the usual immunoprophylaxis medicines alone. The investigational drug in this study is called Defibrotide. The duration of participation for each patient is approximately 6 months.

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

Feasibility of an Electronic Geriatric Assessment (EGA) for Older Adults with Cancer Save

Date Added
February 15th, 2018
PRO Number
Pro00075247
Researcher
Amarinthia Curtis

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to learn more about older adults (age 65 and older) with cancer and their overall health by completing a survey called a "geriatric assessment" (GA). A GA is designed to gather information about a patient's nutritional status, mental health, spiritual health, social support, and memory. In addition, it informs health care providers about how well you carry out your daily activities and collects information on the other health problems you may have.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

Altering memories that increase risk of relapse in alcohol use disorders: A translational clinical neuroscience pilot investigation of a novel pharmacological agent. Save

Date Added
February 6th, 2018
PRO Number
Pro00073523
Researcher
Michael Saladin

List of Studies


Profiles_link
Keywords
Alcohol, Drug Studies, Stage II
Summary

The proposed study will employ treatment-seeking AUD individuals who will be randomly assigned to receive either 15 mg of rapamycin (sirolimus) or placebo immediately after the first of two alcohol cue exposure sessions scheduled to occur on consecutive days. Subjective responses (i.e., craving) and physiological (heart rate & skin conductance) reactivity will be obtained before, during and after cue presentations in both sessions. The durability of any observed treatment effects will be assessed in a Follow-up session performed approximately 10 days following completion of the second session. Treatment effects on self-report measures of drinking behavior during the approximately 10 days preceding the Follow-up session will also be assessed.

Institution
MUSC
Recruitment Contact
Brittany Frasier
843-792-6984
frasibri@musc.edu

A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants with Advanced Renal Cell Carcinoma (FRACTION-RCC) Save

Date Added
December 12th, 2017
PRO Number
Pro00070527
Researcher
Theodore Gourdin

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Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Kidney
Summary

The purpose of this study is to determine whether nivolumab in combination with other therapies is more effective than nivolumab in combination with ipilimumab in treating patients/subjects with advanced renal cell carcinoma.

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

A Dose-Escalation and Dose-Expansion Study of Enfortumab Vedotin (ASG-22CE) in Combination with pembrolizumab and/or chemotherapy for Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer Save

Date Added
December 12th, 2017
PRO Number
Pro00072223
Researcher
Theodore Gourdin

List of Studies

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

This is a study that will test how an experimental drug (enfortumab vedotin) combined with a kind of anticancer drug called an immune checkpoint inhibitor (CPI) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body.

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

Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study Save

Date Added
October 17th, 2017
PRO Number
Pro00070403
Researcher
Richard Silver

List of Studies


Profiles_link
Keywords
Autoimmune disease, Drug Studies, Scleroderma, Skin
Summary

This study is being conducted in order to test the safety of Brentuximab Vedotin in subjects with Diffuse Cutaneous Systemic Sclerosis. The study involves a Screening visit, a Baseline visit and 12 study visits occurring every 3 to 4 weeks, with enrollment lasting approximately 52 weeks, during which enrolled subjects will receive either the study compound or placebo.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5290
gibsonke@musc.edu

Effect of GET73 on magnetic resonance spectroscopy measures of central glutamate and GABA and alcohol cue-elicited brain activation in recently abstinent non-treatment-seeking individuals with Alcohol Use Disorder Save

Date Added
September 26th, 2017
PRO Number
Pro00069862
Researcher
Raymond Anton

List of Studies


Profiles_link
Keywords
Alcohol, Brain, Drug Studies, Substance Use
Summary

The purpose of this study is to evaluate the potential mechanism of action and the safety of GET73, a new drug under development for the reduction of craving and drinking in alcohol dependent individuals. The study involves five to six visits over a three to four week period, including one to two assessment visits and two visits during which participants will be assigned to take, in a double-blinded fashion, both GET73 and a placebo (two visits during each condition). During three of these visits, participants will undergo a one-hour MRI scan. Compensation is available for qualified participants.

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

An Open-label Phase 1/2A Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of TRC253, an Androgen Receptor Antagonist, in Patients With Metastatic Castration-resistant Prostate Cancer Save

Date Added
September 26th, 2017
PRO Number
Pro00067101
Researcher
Michael Lilly

List of Studies


Profiles_link
Keywords
Cancer/Genitourinary, Drug Studies
Summary

This is a multi-center, first-in-human, open-label, Phase 1/2A dose-escalation study in which eligible patients with metastatic castration-resistant prostate carcinoma (mCRPC) will receive oral doses of TRC253. The estimated completion date is September 2018.

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

QUILT-3.055: A Phase IIb, Single-Arm, Multicohort, Open-Label Study of ALT-803 in Combination with a PD-1/PD-L1 Checkpoint Inhibitor in Patients who have Disease Progression Following an Initial Response to Treatment with PD-1/PD-L1 Checkpoint Inhibitor Therapy Save

Date Added
August 22nd, 2017
PRO Number
Pro00068710
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 an advanced form of cancer and your disease improved or remained unchanged after receiving PD-1/ PD-L1 Checkpoint Inhibitor Therapy. The investigational drug in this study is called ALT-803. Participants will receive the study drug ALT-803 in combination with an approved PD-1/PD-L1 Checkpoint Inhibitor Therapy (Pembrolizumab, Nivolumab, Atezolizumab, or Avelumab). The purpose of this research study is to test the effectiveness of the study drug, ALT-803, in combination with pembrolizumab, nivolumab, atezolizumab, or avelumab in with advanced forms of cancer that initially had improvement or no change in disease after receiving checkpoint inhibitor therapy and who now have disease worsening. Participation in this study should take approximately 24 months.

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

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