A Phase 1b, Randomized, Open-Label Study Of PEGylated Recombinant Human Hyaluronidase (PEGPH20) In Combination With Cisplatin Plus Gemcitabine And PEGPH20 In Combination With Atezolizumab And Cisplatin Plus Gemcitabine Compared With Cisplatin Plus Gemcitabine In Hyaluronan-High (HA-high) Subjects With Previously Untreated Unresectable, Locally Advanced Or Metastatic Intrahepatic And Extrahepatic Cholangiocarcinoma And Gallbladder Cancer Save

Date Added
October 24th, 2017
PRO Number
Pro00071570
Researcher
Carolyn Britten

Silhouette
Keywords
Cancer, Cancer/Genitourinary, Men's Health, Women's Health
Summary

The purpose of this study is to study test investigational drugs PEGPH20 and Atezolizumab in combination with the current standard of care medications Cisplatin and Gemcitabine.

Subjects are being asked to participate in this study because they are/have intrahepatic and extra hepatic cholangiocarcinoma or gallbladder adenocarcinoma which are types of cancers associated with the liver or biliary system. The study is sponsored by Halozyme.

This study involves the adiminstration of an invetigational drug (not approved by the FDA) PEGPH20 in order to determine what a safe dose is when given with Cisplatin and Gemcitabine, what the side effects are, and whether or not it will help treat the kind of cancer you have. PEGPH20 is an enzyme (protein that can speed biochemical reactions) that breaks down a specific substance called hyaluronan produced by some tumors. The removal of hyaluronan from tumors has been shown to inhibit tumor growth.

Atezolizumab is an immunotherapy drug which means it assists your immune system in fighting your cancer. This drug has been approved by the United States Food and Drug Administration (FDA) to treat bladder and lung cancer, but is investigational with the drugs described above and for the diagnosis of intrahepatic and extra hepatic cholangiocarcinoma or gallbladder adenocarcinoma . The other therapy that is given in this study is standard of care chemotherapy drugs Cisplatin and Gemcitabine, which are drugs that are routinely given to treat patients with cholangiocarcinoma or gallbladder adenocarcinoma cancers who are not in research studies.

The investigator in charge of this study at MUSC is Dr. Carolyn Britten. Approximately 70 subjects will take part study wide at about 20 centers in the United States and 10 centers in Asia. Halozyme will be providing funding to MUSC and Dr. Britten for conducting this research.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-4271
hcc-clinical-trials@musc.edu

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors Save

Date Added
October 10th, 2017
PRO Number
Pro00069285
Researcher
Carolyn Britten

Silhouette
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study to learn more about a new experimental drug called TSR-022 and its effect on the subject's cancer when used either alone or with another experimental drug called TSR-042. TSR-022 is considered investigational, which means that TSR-022 alone or in combination with TSR-042 has not been approved by any regulatory authorities, including the United States Food and Drug Administration (FDA), and is not available in stores or by prescription.
The main purposes of Part 2 are to:
Look at the ability of TSR-022 when taken alone or in combination with TSR-042 to make the cancer smaller
Confirm the recommended phase 2 dose and dosing schedule of TSR-022 when taken by itself
Confirm the recommended phase 2 dose and dosing schedule of TSR-022 when taken with TSR-042 as Combination Therapy.
This study will enroll patients with advanced melanoma, advanced colorectal cancer and advanced non-small cell lung cancer (NSCLC).

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-4271
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

Silhouette
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

Silhouette
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

Silhouette
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

Silhouette
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 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

Silhouette
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

Silhouette
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

Silhouette
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

Silhouette
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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