AZD9150, a STAT3 Antisense Oligonucleotide, in People With Malignant Ascites

Summary

Background: \- Some people with gastrointestinal or ovarian cancer also have ascites. That is free fluid built up in the abdomen. Researchers want to see if a new drug can affect some of the immune cells in the ascites. This may also treat the cancer. Objective: \- To look at the immune markers the ascites of people with gastrointestinal or ovarian cancer. Eligibility: \- Adults age 18 and older with a malignancy of the gastrointestinal tract (GI) tract or metastatic ovarian cancer. As a result, they have ascites in the abdomen. Design: * Participants will be screened with: * Medical history, physical exam, and blood tests. * Echocardiogram: sound waves make images of the heart. * Electrocardiogram: measures electrical activity of the heart. * Paracentesis: a needle will be inserted in the abdomen and will remove some of the ascites fluid. * They may have a tumor biopsy. * Participants will get AZD9150 through a vein for 3 hours. They will get this 6 times in cycle 1 and 4 times all other cycles. Each cycle is 28 days. * Each cycle, participants will: * Have a physical exam. * Have blood tests weekly. * Be asked about how they feel and any medicines they are taking. * After every 2 cycles (about every 2 months), participants will have scans and x-rays of their tumor. * Participants will have paracentesis 2 more times during the study. They will have another echocardiogram. * At the end of therapy, participants will have a physical exam and blood tests. They will be asked about how they feel and any medicines they are taking.

Timeline

Start

2015-04-03

Primary completion

2016-04-07

Completion

2016-04-07

Drugs

Indications