A Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Date Added
February 23rd, 2021
PRO Number
Pro00106203
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have a tumor that cannot be removed through surgery (unresectable) or may have spread (metastasized) to other parts of their body. In this study, ASP1951 will be given alone (monotherapy) or combined with pembrolizumab (combination therapy). Both ASP1951 and pembrolizumab will be considered study drug. Pembrolizumab has been approved by FDA for use in patients with skin, lung, cervical cancer, certain cancers of head and neck and other cancers but may not be approved to treat all types of cancer. However, the use of ASP1951 plus pembrolizumab has not been approved by regulatory authorities and is therefore investigational. The study consists of 3 periods: screening (up to 28 days), treatment (up to 48 weeks [16 cycles]) and follow up (up to 45 weeks), followed by an optional re-treatment period for participants that qualify. The re-treatment period will allow participants to receive study drug treatment again for up to 16 additional cycles (approximately 48 weeks), for a maximum total treatment and re-treatment period of 32 cycles (approximately 96 weeks). Both study drugs are administered intravenously (into the vein).This is the first time the investigational study drug ASP1951 is being tested in humans; however, studies in animals showed that the study drug is safe to be tested in humans.

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

A PHASE III TRIAL OF PERIOPERATIVE VERSUS ADJUVANT CHEMOTHERAPY FOR RESECTABLE PANCREATIC CANCER

Date Added
November 6th, 2020
PRO Number
Pro00104900
Researcher
Katherine Morgan

List of Studies


Keywords
Cancer/Gastrointestinal, Pancreas
Summary

This study is for patients with pancreatic cancer. The purpose is to see if researchers can increase the chance of pancreatic cancer staying away by giving them chemotherapy before and after surger

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

A Randomized Phase II Study of Gemcitabine and Nab-Paclitaxel Compared with 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan in Older Patients with Treatment Naïve Metastatic Pancreatic Cancer (GIANT)

Date Added
October 8th, 2020
PRO Number
Pro00104741
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal, Pancreas
Summary

This study is for patients over 70 with metastatic pancreatic cancer. We are doing this study because we want to find out what the best approach to lengthen the lives of "vulnerable" patients over the age of 70 with mPCA is.

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

DULOXETINE TO PREVENT OXALIPLATIN-INDUCED CHEMOTHERAPY-INDUCED PERIPHERAL NEUROPATHY: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II TO PHASE III STUDY

Date Added
July 6th, 2020
PRO Number
Pro00101249
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal
Summary

This study is for patients receiving oxaliplatin for their cancer treatment. The study is being done to see if duloxetine (either 30 mg or 60 mg) prevents numbness, tingling, and/or pain caused by your cancer treatment with oxaliplatin. The study is being done to see if duloxetine can prevent OIPN (oxaliplatin-induced peripheral neuropathy).

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

Protocol RR3 (CP-03-001), Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine Plus Nab-Paclitaxel Following Induction With Sequential IV Gemcitabine Plus Nab-Paclitaxel and Radiotherapy for Unresectable Locally Advanced Pancreatic Cancer (TIGeR-PaC)

Date Added
March 2nd, 2020
PRO Number
Pro00093024
Researcher
D. Thor Johnson

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

The purpose of this study is to find out if we can prolong your survival by delivering the chemotherapy drug through an artery that goes directly into your pancreas and to find out if this experimental approach is better or worse than the usual approach for your pancreatic cancer. All subjects will receive induction therapy of IV gemcitabine plus nab-paclitaxel, as well as radiation therapy for approximately four months. Subjects who remain eligible will then be randomized to receive either intra-arterial chemotherapy with gemcitabine; or to continue gemcitabine plus nab-paclitaxel. Subjects will receive the randomized treatments for up to 16 weeks or until progression. Both groups will receive either IV gemcitabine and nab-paclitaxel or oral capecitabine following the 16 week treatment course until disease progression at the discretion of the Investigator.

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

RANDOMIZED DOUBLE-BLIND PHASE III TRIAL OF VITAMIN D3 SUPPLEMENTATION IN PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC COLORECTAL CANCER (SOLARIS)

Date Added
February 4th, 2020
PRO Number
Pro00096338
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal
Summary

This study is for patients with previously untreated metastatic colorectal cancer. The purpose of the study is to see if adding a new drug to the usual combination of drugs can lower the chance of the colorectal cancer growing or spreading.

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

Phase II/III Study of Circulating tumOr DNA as a Predictive BiomaRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)

Date Added
January 13th, 2020
PRO Number
Pro00096360
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer/Gastrointestinal
Summary

This study is for patients with colon cancer. The purpose is to determine whether to recommend chemotherapy of no further treatment after surgery for an early stage colon cancer, by taking a blood sample and testing for the presences of circulation tumor DNA (ctDNA)?

Institution
MUSC
Recruitment Contact
Nancy McGaha
864-725-7129
nmcgaha@selfregional.org

Creon (pancrelipase) therapy for subjects with exocrine pancreatic insufficiency (EPI) due to pancreatic cancer: A double-blind, randomized, parallel design with 2 dose cohorts of pancrelipase in resected pancreatic cancer subjects and an open-label single dose cohort in non-resected pancreatic cancer subjects

Date Added
December 10th, 2019
PRO Number
Pro00089601
Researcher
Katherine Morgan

List of Studies


Keywords
Cancer/Gastrointestinal, Pancreas
Summary

The purpose of this study is to evaluate the effects of an FDA approved drug called pancrelipase on fat absorption in your body. Pancrelipase is an FDA approved drug that can be used to treat exocrine pancreatic insufficiency, which is a condition where the pancreas organ in the small intestine does not deliver enough digestive enzymes to breakdown food you eat.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults with Colorectal Cancer: The M&M Study

Date Added
October 15th, 2019
PRO Number
Pro00093504
Researcher
Daniel Reuben

List of Studies


Keywords
Cancer/Gastrointestinal
Summary

This study is for older adults with colorectal cancer. The purpose is to determine if low muscle mass plays a role in side effects from chemotherapy.

Institution
MUSC
Recruitment Contact
Nancy McGaha
864-725-7129
nmcgaha@selfregional.org

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) plus Platinum and Fluoropyrimidine Versus Placebo plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Date Added
October 7th, 2019
PRO Number
Pro00090649
Researcher
Paul O'Brien

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

This is a research study to compare the effects and safety, of tislelizumab plus chemotherapy to placebo (an inactive substance) plus chemotherapy on you and your Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (GC/GEJ) to find out the most effective treatment. The study will take place over 3 years 4 months and will include about 17-18 office -visits to the study doctor.

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



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