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.
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).
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.
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.
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.
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.
The study will have 2 parts (Part A and Part B). Part A of this research study (the dose escalation phase) will test the safety and effectiveness of the different doses of ALKS 4230 (study drug) to find the one that is the safest and most effective. Part B of this study (the dose expansion phase) will use the safe dosing determined in Part A to see how effectively the combination of ALKS 4230 and pembrolizumab treats your solid tumors.LKS 4230 is an investigational (experimental) drug; this means that is has not been approved by the US Food and Drug Administration (FDA) to treat your disease. This is an open-label study which means that all subjects will be taking the active study drugs.You can be in the study for as long as it is clinically beneficial to you.