The Effects of Statin Therapy on Brain Micro-Structure Quantified by MRI and the Relationship to Cognitive Function Save

Date Added
December 9th, 2015
PRO Number
Pro00019608
Researcher
Joseph Helpern
Keywords
Brain, Healthy Volunteer Studies, Women's Health
Summary

This study is being done to determine if the changes in cholesterol levels by the use of statins can result in changes in the brain's micro-structure. These changes are going to be studied to see if they cause changes in a person's ability to process thoughts. This study is for women between the ages of 45 and 85.

Institution
MUSC
Recruitment Contact
Rachael Deardorff
843-876-2470
deardorf@musc.edu

A Phase Ib/II Clinical Study of BBI608 in Combination with Sorafenib or BBI503 in Combination with Sorafenib in Adult Patients with Hepatocellular Carcinoma Save

Date Added
December 8th, 2015
PRO Number
Pro00040789
Researcher
Carolyn Britten
Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies, Liver, Men's Health, Women's Health
Summary

This study for patients with advanced liver cancer will look at sorafenib in combination with BBI608 and at sorafenib in combination with BBI503. Approximately 15 subjects will be enrolled at MUSC. The study drug that participants receive along with sorafenib will be determined by a process called randomization. All subjects will receive sorafenib. You will be assigned to receive either BBI608 and sorafenib or BBI503 and sorafenib by a process similar to flipping a coin. You will not be able to choose which of the two study drugs you will receive in combination with sorafenib. Also, the study researchers cannot choose and do not have control over which of the two study drugs you will receive in combination with sorafenib.

The main goals of the Phase Ib part of this research study are to:
o Find a dose of the study drug (either BBI608 or BBI503) that can be given in combination with sorafenib without causing severe side effects
o Determine the level of the study drug (either BBI608 or BBI503) and sorafenib in the bloodstream
o Determine if the study drug (either BBI608 or BBI503) and sorafenib cause any change in the patient and their cancer

This study is not intended to evaluate whether the study drug (either BBI608 or BBI503) is more or less effective than is sorafenib alone in the treatment of liver cancer.

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

A Phase 1/2 Study of INCB053914 in Subjects With Advanced Malignancies Save

Date Added
November 24th, 2015
PRO Number
Pro00049779
Researcher
Saurabh Chhabra
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with certain advanced cancers or diseases where cells grow too much including leukemia (for example, Acute Myeloid Leukemia [AML]), Myelodysplastic Syndrome (MDS), Myelodysplastic/ Myeloproliferative Neoplasms (MDS/MPN), Myelofibrosis (MF), Multiple Myeloma (MM), and lymphoproliferative disporders (LPDs). The investigational drug in this study is INCB053914. The purpose of this study is to evaluate the safety and tolerability and to select the doses that will be studied further. Participants can expect to be in this study for about 4 to 6 months but this will vary depending on if conditions occur, such as progression of disease, new findings during the study or the study finishes.

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

Multi-arm, Non-randomized, Open-Label Phase IB Study to Evaluate GSK3052230 in Combination with Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects with Solid Malignancies and Deregulated FGF Pathway Signaling Save

Date Added
November 19th, 2015
PRO Number
Pro00040005
Researcher
John Wrangle
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study is to find out how well the investigational (not approved by the Food and Drug Administration) study drug, GSK3052230 ?GSK230? works against the subject's tumor when given together with chemotherapy. Researchers also want to find out which is the best dose of GSK230 when it is given with standard chemotherapy drugs for treating lung cancer or mesothelioma. The subjects will be asked to take part in this study because their cancer may have an abnormal level of some genes or proteins in their cancer cells. This can be either a gene called FGFR1 or high levels of some proteins related to the FGF pathway (which can lead to tumor growth). GSK230 is able to block the FGF pathway.
If the subject agrees to participate, s/he will receive an intravenous (IV) infusion of GSK230 for 30 minutes each week in a 21 day cycle for the duration of the study. Subjects can receive treatment until the disease gets worse or they experience harmful side effects.
Up to approximately 160 people from across the world (from North America and Europe) will take part in this study. Additional countries may join the study in the future. About 10 of those subjects will be enrolled at MUSC under the care Keisuke Shirai, MD.

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

A Phase Ib/II Multi-Center, Open Label, Dose Escalation Study of WNT974, LGX818 and Cetuximab in Patients with BRAFV600-Mutant KRAS wild-type Metastatic Colorectal Cancer Harboring Wnt Pathway Mutations Save

Date Added
November 19th, 2015
PRO Number
Pro00040875
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study is to assess the safety and anti-tumor activity of the triple combination of investigational drugs (not yet approved by the Food and Drug Administration) WNT974, LGX818 and the FDA approved drug cetuximab in people who have metastatic colorectal cancer, and whose tumor has changes in a gene called BRAF as well as in the genes called RNF43 and/or RSPO.
The study is divided into 2 parts. Subjects might be asked to participate in the first part or in the second part.
In the first part (called phase Ib), 3-6 subjects will start at the lowest planned dose of WNT974 in combination with a dose of LGX818 that has been used in other clinical studies and the approved dose for cetuximab. About 15 subjects will join in this part of the study at multiple centers around the world.
In the second part of the study (called phase II), subjects will receive the doses of medicines that have been considered to be the best combination of doses from the first part of the study. The purpose of this part of the study is to determine if the combination of these 3 medicines is effective for the treatment. About 40 subjects will join in this part of the study.
About 6 subjects will be enrolled at MUSC under the care of Dr. Carolyn Britten.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu

Differences in the migration and cell surface marker expression of Mesenchymal Stem Cells (MSC) obtained from the placenta and Umbilical Cord Blood Save

Date Added
November 18th, 2015
PRO Number
Pro00009198
Researcher
Eugene Chang
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The objective of this study is to determine whether there are alterations in the migration and cell surface marker expression of MSC?s obtained from the placenta and umbilical cord in uncomplicated pregnancies

Institution
MUSC
Recruitment Contact
Tamara Saunders
843-792-6992
cordells@musc.edu

PROSPECTIVE, NON-INTERVENTIONAL STUDY OF DISEASE PROGRESSION AND TREATMENT OF PATIENTS WITH POLYCYTHEMIA VERA IN UNITED STATES ACADEMIC OR COMMUNITY CLINICAL PRACTICES Save

Date Added
November 10th, 2015
PRO Number
Pro00046510
Researcher
John Lazarchick
Keywords
Cancer/Other, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with Polycythemia Vera (PV) and are being actively managed for your PV. The purpose of this study is to find out more information about people with PV, follow the course of the disease in these people, and find out how the disease and standard medical care affect the daily life of people being treated for PV.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

A Randomized, Placebo Controlled Phase 2b/3 Study of ABT-414 with Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects with Newly Diagnosed Glioblastoma (GBM) with Epidermal Growth Factor Receptor (EGFR) Amplification Save

Date Added
November 10th, 2015
PRO Number
Pro00049546
Researcher
David Cachia
Keywords
Cancer, Glioblastoma, Men's Health, Women's Health
Summary

The main purpose of this study is to research the investigational drug (not yet approved by the Food and Drug Administration), ABT414. Human studies have shown ABT-414 can shrink EGFR (epidermal growth factor receptor)-amplified glioblastomas (GBM's) in some people whose tumors were growing despite earlier RT (radiation) and chemotherapy treatment. This investigational drug will be given at the same with radiation therapy and the FDA approved chemotherapy drug, temozolomide.
If the subject meets the study requirements and agrees to volunteer, they will be on the study for approximately 2 years, and will be asked to go to study visits every 2 weeks.
Approximately 720 subjects will be asked to take part, 8 of them will be at MUSC.

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

A Phase 1, Open-Label, Multicenter, Dose Escalation Study to Assess the Safety and Tolerability of MLN7243, an Inhibitor of Ubiquitin-Activating Enzyme (UAE), in Adult Patients With Advanced Solid Tumors Save

Date Added
November 10th, 2015
PRO Number
Pro00049515
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study is to research the investigational (not approved by the Food and Drug Administration or FDA) drug MLN7246 in patients with advanced solid tumors which has not responded well to treatment and all other standard therapies have been exhausted. This study will research the following:
?The side effects and risks of MLN7243
?The highest dose of MLN7243 that can be given to patients without causing side effects and risks that are too severe
?How much MLN7243 is in your blood and how your body gets rid of MLN7243
?How MLN7243 effects proteins that are involved in how the drug works in the body
The study is sponsored by Millenium Pharmaceuticals. The investigator in charge of this study at MUSC is Carolyn Britten, MD. The study is being done at 8 sites within the United States. Approximately 119 people will take part study-wide and 10 subjects will take part at MUSC.

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

A RANDOMIZED TRIAL OF PELVIC IRRADIATION WITH OR WITHOUT CONCURRENT WEEKLY CISPLATIN IN PATIENTS WITH PELVIC-ONLY RECURRENCE OF CARCINOMA OF THE UTERINE CORPUS Save

Date Added
November 5th, 2015
PRO Number
Pro00039931
Researcher
Jeffrey Elder
Keywords
Cancer, Cancer/Gynecological, Obstetrics and Gynecology, Women's Health
Summary

This is a Phase II study for women diagnosed with pelvic-only and or vaginal recurrence of endometrial cancer following complete hysterectomy and bilateral salpingo-oophorectomy at the time of initial diagnosis . Patients will be randomized to receive external pelvic radiation for approximately 5 weeks followed by brachytherapy OR external pelvic radiation for approximately 5 weeks plus weekly chemotherapy with cisplatin followed by brachytherapy. The study is designed as a screening study to estimate the benefit on progression-free survival of the addition of cisplatin to external pelvic irradiation, overall survival, side effects and evaluate factors at study entry and from original hysterectomy as potential prognostic factors.

Institution
Greenville
Recruitment Contact
Anna Polan
8645222063
apolan@ghs.org

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