A Phase 1/2 Study on the Safety of Rovalpituzumab Tesirine Administered in Combination with Nivolumab or Nivolumab and Ipilimumab for Adults with Extensive-Stage Small Cell Lung Cancer Save

Date Added
June 27th, 2017
PRO Number
Pro00065422
Researcher
John Wrangle
Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with extensive-stage small cell lung cancer (SCLC). This study is being conducted to test whether or not rovalpituzumab tesirine (SC16LD6.5) combined with nivolumab alone or with nivolumab and ipilimumab are useful treatments for small cell lung cancer, after at least one prior treatment has failed.The investigational drugs in this study are Rovalpituzumab Tesirine (SC16LD6.5), Nivolumab (BMS-936558, MDX1106, ONO-4538, Opdivo®), and Ipilimumab (MDX-010, Yervoy®) . If participants agree to take part in this study, their involvement will last for as long as their study doctor confirms their cancer is not getting worse and there have been no significant side effects. There is no limit to the number of cycles of study treatment participants can receive.

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

An Open-Label, Multicenter, Dose-Escalation Phase I Study To Evaluate The Safety, Pharmacokinetics, And Therapeutic Activity Of Ro6958688, A Novel T-Cell Bispecific Antibody That Targets The Human Carcinoembryonic Antigen (Cea) On Tumor Cells And Cd3 On T Cells, Administered Intravenously In Patients With Locally Advanced And/Or Metastatic Cea(+) Solid Tumors Save

Date Added
May 23rd, 2017
PRO Number
Pro00065238
Researcher
Michael Lilly
Keywords
Men's Health, Women's Health
Summary

The purpose of this study is to find out, as a main objective, at which doses RO6958688 (study drug) can be administered safely to subjects and what the side effects are. Additionally, the effects of RO6958688 in the subject's body, and particularly in the subject's tumor, will be evaluated. The study also aims to find out if RO6958688 can slow down the growth of tumors or stop the cancer, in subjects with locally advanced and/or metastatic solid tumors.
RO6958688 is an investigational study drug which means it has not been approved by the FDA.
Subjects will receive RO6958688 weekly for several weeks or once every three weeks for several weeks. Depending on when the subject will be enrolled into the study, they will receive RO6958688 according to one of 3 different dosing schedules. The dose to be received will depend upon the observations made in all patients who have received the RO6958688 before you. Approximately 180 subjects will enroll into this part of the study, approximately 10 will take part at MUSC. Dr. Lilly will be the Primary Investigator at MUSC.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-4271
hcc-clinical-trials@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Parallel-Group Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older with Insomnia Disorder Save

Date Added
May 9th, 2017
PRO Number
Pro00066197
Researcher
Thomas Uhde
Keywords
Aging, Men's Health, Sleep Disorders, Women's Health
Summary

The study is a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study of 2 dose levels of lemborexant for approximately 6 weeks in approximately 950 participants, 55 years or older with insomnia disorder. Participants will be males 65 years or older or females 55 years or older. At least 60% of the participants will be age 65 years or older. The study will have 2 phases: The Prerandomization Phase and the Randomization Phase. Including both phases, the study will last for a minimum of 65 and a maximum of 81 days per participant.

Institution
MUSC
Recruitment Contact
Allison Wilkerson
8437924636
wilkersa@musc.edu

AN OPEN-LABEL PHASE 2 STUDY OF DENINTUZUMAB MAFODOTIN (SGN-CD19A) IN COMBINATION WITH RCHOP (RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, VINCRISTINE, AND PREDNISONE) OR RCHP (RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE) COMPARED WITH RCHOP ALONE AS FRONTLINE THERAPY IN PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) OR FOLLICULAR LYMPHOMA (FL) GRADE 3B Save

Date Added
April 11th, 2017
PRO Number
Pro00064390
Researcher
Valeriy Sedov
Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with diffuse large B-cell lymphoma (DLBCL) or Grade 3b follicular lymphoma that has never been treated. The investigational drug in this study is denintuzumab mafodotin. The purpose of this study is to find out what the side effects are and whether it is more or less effective when it is given together with other drugs that are a standard approved treatment for use in patients with lymphoma (DLBCL or FL3B). Participants can expect to be in the study for 4 years or until the study is closed or until they stop taking part.

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

An Open-label, Multicenter, Dose Escalation and Expansion Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Therapeutic Activity of Ro6958688 in Combination With Atezolizumab in Patients With Locally Advanced and/or Metastatic Cea-positive Solid Tumors Save

Date Added
March 28th, 2017
PRO Number
Pro00064800
Researcher
Michael Lilly
Keywords
Men's Health, Women's Health
Summary

The purpose of this study is to find out at which doses the investigational drug RO6958688 (study drug) can be administered safely to patients in combination with atezolizumab (study drug), and what the side effects are when both drugs are given together.
The study will be conducted in two parts.
Part I ? Patients will receive the study drug RO6958688 every week or every 3 weeks and atezolizumab every 3 weeks
Part II ? Patients will receive study drugs with the dose and schedule of RO6958688 determined in the Part I of the study and atezolizumab at 1200 mg every 3 weeks. Approximately 25 patients may be enrolled for this expansion part.
The investigator in charge of this study at MUSC is Dr. Michael Lilly. The study is being done at 26 sites in Europe and in the USA . Approximately 125 people will take part study-wide, and approximately 5 at MUSC.

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

A Phase I, First-in-Human, Dose Escalation Trial of MSC2363318A, a Dual p70S6K/Akt Inhibitor, in Subjects With Advanced Malignancies Save

Date Added
March 14th, 2017
PRO Number
Pro00060912
Researcher
Sara Giordano
Keywords
Cancer, Men's Health, Women's Health
Summary

MSC2363318A is an investigational drug that is being evaluated for the treatment of subjects with advanced malignancies. Investigational means that it has not been approved by the Food and Drug Administration (FDA), and is still being tested for safety and effectiveness. This study will be divided into 2 parts. MUSC will participate in Part 2. The investigational drug will be given as a monotherapy, in combination with Tamoxifen (an FDA approved drug) and will be given in combination with Trastuzumab (also an FDA approved drug). The study is sponsored by EMD Serono. The investigator in charge of this study is Dr. Sara Giordano. The study is being done at 12 sites nationally. Approximately 64 people will take part, and 5 will take part at MUSC. In order to be eligible, subjects must be older than 18, have advanced maliginancies and specific genetic mutations.
The duration of the study will depend on how the subjects cancer responds to the medication and how it is tolerated.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8438137372
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
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

A PHASE 1/2A OPEN-LABEL, MULTI-DOSE, MULTI-CENTER ESCALATION AND EXPLORATORY STUDY OF CERDULATINIB (PRT062070) IN PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)/SMALL LYMPHOCYTIC LYMPHOMA (SLL) OR B-CELL OR T-CELL NON-HODGKIN LYMPHOMA (NHL) Save

Date Added
January 10th, 2017
PRO Number
Pro00061324
Researcher
Valeriy Sedov
Keywords
Cancer, Cancer/Leukemia, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with 1 of the following types of cancer : Chronic Lymphocytic Leukemia (CLL), Small-Cell Lymphocytic Lymphoma (SLL), or of Non-Hodgkin Lymphoma (NHL) of which there are 2 mains types: B-Cell NHL or T-Cell NHL. The investigational drug being studied is PRT062070; it is also called ?cerdulatinib.?The primary purpose of Phase 2a of this study is to assess safety and the activity of the study drug in patients who have CLL, SLL, or B-cell NHL, or T-cell NHL. You will take the study drug until you withdraw your agreement to continue to take part in this study, your cancer becomes worse, you have severe side effects, the research study ends, or you have completed dosing with the study drug and all follow-up study visits.

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

Phase II trial of vosaroxin in combination with infusional cytarabine in patients with untreated AML. Save

Date Added
January 10th, 2017
PRO Number
Pro00060039
Researcher
Robert Stuart
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for adult patients that are suspected to have or were recently diagnosed with acute myeloid leukemia (AML) and have not yet received treatment for AML. The investigational drug in this study is vosaroxin. The participants can expect to be in this study until they have completed both induction therapies. However, after treatment, they will be in follow-up that consists of disease status updates every 3 months indefinitely.

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

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