Clinical Research

A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients with Cystic Fibrosis Treated with Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors

Principal Investigator: Richard Ahrens, MD

The purpose of this research study is to determine the number of patients affected by Fibrosing Colonapathy in people with cystic fibrosis and to learn more about what might cause it, including use of pancreatic enzyme supplements. 

A Randomized, open-label, Phase 2 study of the IDO inhibitor INCB024360 versus tamoxifen for subjects with biochemical-recurrent-only epithelial ovarian cancer, primary peritoneal carcinoma, or fallopian tube cancer following complete remission with first-line chemotherapy

Principal Investigator:Michael Goodheart, MD

This study is being done to find out if the experimental drug INCB024360 is safe and has helpful effects when given to women with a certain type of ovarian cancer. Women who have elevated CA-125 (a marker in the blood used to track the disease) and no evidence of disease ("biochemical recurrent only") after achieving complete remission with first-line chemotherapy will be asked to take part. This study will measure how long women who take INCB024360 survive without disease recurrence after study treatment, compared to those that take a hormonal therapy called tamoxifen. About 110 women with biochemical recurrent only ovarian cancer will be participating at approximately 35 study centers.

A multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive midgut carcinoid tumors

Principal Investigator: David Bushnell, MD; Thomas O'Dorisio, MD

Participants in this study suffer from a disease called GEPNET (Gastro-Entero-Pancreatic Neuroendocrine-Tumor), which is a group of progressive malignant tumors. These cases have arisen from the small bowel (midgut carcinoid). Physicians have determined that the tumor/s cannot be removed completely by surgery. This study includes participants who are undergoing therapy with 20-30 mg of Octreotide LAR (Long Acting Release), a drug that should slow down progression or activity of the tumor(s). However, participants' physicians have concluded, through assessing recent CT/MRI scans (Computed Tomography/Magnetic Resonance Imaging), that the drug under the current dosing regimen is not working to prevent disease progression.

The aim of this study is to compare two treatments:

1. Peptide Receptor Radionuclide Therapy (PRRT). This is a new treatment being studied to determine the safety, efficacy and tolerability in patients with this type of cancer. This PRRT treatment is based on the administration of a radioactive product, Lutathera.

2. Octreotide LAR, 60 mg as an intramuscular injection. Participants in this study are currently taking this drug, but at a lower dose, which is considered to be the standard treatment.

The purpose for using both treatments is the same. They are both used to try and stop the disease from getting worse and perhaps to even reduce the size of tumor(s).

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in

Principal Investigator:Richard Ahrens, MD

The purpose of this study is to learn more about the safety and effects of Kalyedco in subjects with CF who are 6 years old and older, with at least one copy of the R117H-CFTR mutation.  We will also look at how Kalyedco may affect your body and how your body breaks down and eliminates ivacaftor. 

Study for Patients with Type 1 Diabetes To Compare Safety, Effectiveness, and Tolerability of New More Concentrated Form of Insulin Glargine

Principal Investigator: Eva Tsalikian, MD

A 6-Month, Multicenter, Randomized, Open Label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus Injected in the Morning or Evening in Patients with Type 1 Diabetes Mellitus with a 6-month Safety Extension Period

Adults with type 1 diabetes are invited to participate in a research study to compare the safety, effectiveness, & tolerability of new more concentrated form of insulin glargine with the currently marketed form known as Lantus® in adults with type 1 diabetes.    There are 10 on-site study visits over an approximate 12 month period.