Pembrolizumab In Combination With Anti-platelet Therapy For Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck Save

Date Added
August 15th, 2017
PRO Number
Pro00069442
Researcher
Carolyn Britten
Keywords
Cancer/Head & Neck
Summary

This is a study that looks at the use of anti-platelet therapy and chemotherapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC). Anti-platelet therapy is the use of drugs that reduce the blood?s ability to form clots. The overall goal of this study is to see if this therapy combination can increase the body?s ability to fight the disease.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-cto-clinops@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

Pilot Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in ER+, Metastatic Breast Cancer Patients Receiving Endocrine Therapy Save

Date Added
February 21st, 2017
PRO Number
Pro00062663
Researcher
Carolyn Britten
Keywords
Cancer/Breast
Summary

The purpose of this study is to identify safe pharmaceutical agents that can reduce the AGE levels in subjects with advanced cancer. The term ?AGE? (advanced glycation endpoints) refers to sugar-derived metabolites that are linked to lifestyle choices and can contribute to cancer.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-cto-clinops@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

A Phase 1b Dose Escalation Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLX51107 in Subjects with Advanced Malignancies Save

Date Added
March 8th, 2016
PRO Number
Pro00052841
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

The participants in this study will be the first people to receive PLX51107 (an investigational drug not yet approved by the FDA). PLX51107 works by targeting and inhibiting certain activities within cells that promote tumor growth in patients that have advances cancers. By inhibiting these activities, PLX51107 may help to stabilize or reduce the growth of tumor cells. PLX51107 has shown anti-cancer activity in laboratory studies; however, it is not yet known whether it will work in humans.
There will be several dose levels of PLX51107 that will be explored to determine the best dose. At the beginning of the study, 3 patients will be treated with a low dose of PLX51107. If this dose does not cause bad side effects, the drug will be given at a higher dose for the next 3 new patients in each treatment group who take part in the study. Dose increases will continue until the highest, most tolerable dose is determined for PLX51107.
There will be up to 60 subjects enrolled into the study nationwide, aprroximately 8 of those subjects will be enrolled at MUSC.

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

A Phase II Study of ABC294640 in Patients with Advanced Hepatocellular Carcinoma Who Have Progressed on Sorafenib Save

Date Added
January 19th, 2016
PRO Number
Pro00050863
Researcher
Carolyn Britten
Keywords
Cancer/Gastrointestinal
Summary

This study is for adult patients diagnosed with hepatocellular carcinoma (HCC). The purpose of this study is to look at the safety and effectiveness of the investigational drug ABC294640 in participants with HCC. It is an investigational drug because it has not been approved by the Food and Drug Administration (FDA) for treatment of cancer. It is experimental, but the FDA has given its permission for ABC294640 to be tested in this research study. Patients will have screening tests to determine if he or she is eligible to participate in this study. If the patients is eligible and wishes to enroll, he or she will begin treatment with ABC294640. Study treatment will last until the subject is no longer benefiting from the study drug.

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

A Phase 1a/1b Study of Cabiralizumab in Combination with Nivolumab in Patients with Selected Advanced Cancers Save

Date Added
November 24th, 2015
PRO Number
Pro00049194
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study is to test a new investigational compound called FPA008, in combination with another study drug called nivolumab.
This study consists of two parts, Phase 1a and Phase 1b. MUSC is only participating in Phase 1b. Phase 1b will be open to subjects who have the following types of cancer:
Lung cancer
Melanoma (skin cancer)
Pancreatic cancer
Colorectal cancer
Head and Neck cancer
Glioblastoma (brain cancer)
Participation in this study will last for at least two 14 day cycles.

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

A Phase 1 Study of LY3076226, a Fibroblast Growth Factor Receptor 3 (FGFR3) Antibody-Drug Conjugate,in Patients with Advanced or Metastatic Cancer Save

Date Added
August 25th, 2015
PRO Number
Pro00047067
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study is to determine how much of the investigational drug LY3076226 can be safely given to subjects with advanced cancer and whether LY3076226 can be of benefit to subjects with advanced cancer.
In this study, several different doses of LY3076226 will be explored. The doses given to the subjects will depend on when they enter the study.
Subjects can expect to be on this study for approximately 5 months.

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

A Phase Ib/II Clinical Study of BBI608 in Combination with Standard Chemotherapies in Adult Patients with Advanced Gastrointestinal Cancer Save

Date Added
July 28th, 2015
PRO Number
Pro00046142
Researcher
Carolyn Britten
Keywords
Cancer/Gastrointestinal, Cancer/Genitourinary
Summary

The purpose of this research study is to determine the safety of BBI608 and the highest dose of this drug that can be given to people safely in combination with six different anti-cancer regimens. BBI608 is a newly discovered drug that may treat cancer by killing cancer stem cells; a highly malignant portion of cancer cells that are fundamentally responsible for malignant growth, relapse and metastatic spread of the disease. This drug has been used in other research studies, and information from those research studies suggests that BBI608 may help treat cancer by killing the highly malignant cancer stem cells. In the laboratory studies, BBI608 given in combination with these standard anti-cancer drugs has been shown to effectively kill cancer cells.
The study is sponsored by Boston Biomedical. The investigator in charge of this study is Carolyn Britten, MD. It is expected that about 21-24 participants will take part in this research study in each of the above combinations globally and 5 will take part at MUSC.

Institution
MUSC
Recruitment Contact
David Longshore
843-792-8113
longshor@musc.edu

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 under Adaptable Dosing Schedules in Patients with Advanced Solid Malignancies Save

Date Added
June 10th, 2014
PRO Number
Pro00034909
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

AZD5363 is a new anti-cancer treatment being developed by AstraZeneca that has not yet been approved for use. This study is part of a research project for collecting information about the safety and effectiveness of this treatment for the first time. The main purpose of the study is to establish a safe dose of the drug by gathering information on how well it is tolerated, any potential side effects it may cause and collecting data about how your cancer responds to the drug. The study will also measure the levels of AZD5363 in the blood and the action of AZD5363 in the body over a period of time. It will also indicate whether the drug has an effect on the type of cancer that the subjects have.

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

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