AZD9150, a STAT3 Antisense Oligonucleotide, in People With Malignant Ascites
Status:
Terminated
Trial end date:
2016-04-07
Target enrollment:
Participant gender:
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.