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

Stopped early · Phase 2

Conditions studied: Ovarian Cancer, Ovarian Neoplasms, Ascites, Gastrointestinal Cancer, Gastrointestinal Neoplasms

In brief

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.

Key facts

Study ID

NCT02417753

Run by

National Cancer Institute (NCI)

People needed

1

Starts

2015-04-03

Expected to finish

2016-04-07

Last updated by the study team

2017-05-15

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients who are receiving any other investigational agents.
• History of prior Janus kinase (JAK) or signal transducer and activator transcription 3 (STAT)3 inhibitor treatment.
• Patients with known brain metastases or spinal cord compression should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Patients must not have other invasive malignancies within the past 3 years (with the exception of adequately treated basal or squamous cell skin cancers, carcinoma in situ of the cervix and ductal carcinoma in situ (DCIS) of breast).
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD9150.
• Incompletely healed surgical incision prior to enrolment
• Ongoing therapy with oral or parenteral anticoagulants (e.g., heparin, warfarin). Lowdose anticoagulants for maintenance of catheter patency are not exclusionary.
• Any of the following cardiac criteria:
• Mean resting corrected Q wave and T wave (QT) interval (QTcF) > 480 msec obtained from 3 electrocardiograms (ECGs)
• Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block
• Patients with uncontrolled hypertension (systolic blood pressure (SBP)> 155, diastolic blood pressure (DBP)> 90), unstable coronary disease (unstable angina, evidence of congestive heart failure (CHF), or myocardial infarction (MI) within 6 months of study)
• New York Heart Association (NYHA) greater than or equal to Grade II or greater.
• History of myocardial infarction within 6months prior to screening.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant and/or breastfeeding
• Human immunodeficiency virus (HIV)-positive patients or with history of hepatitis or with current chronic or active hepatitis. A past history of Hepatitis A is allowed.
• History of recurrent bacterial infections unrelated to hepatocellular carcinoma (HCC) (particularly skin or lung)
• Bacterial peritonitis within 30 days
• History of, or presently active or chronic viral infections (i.e. zoster or hepatitis)
• History of known latent or active tuberculosis, signs of active or latent tuberculosis on chest X-ray, skin test showing an induration of >10 mm or more or according to local recommendations.
• Active bleeding disorders and high likelihood of bleeding or conditions or medications known to increase the risk of bleeding. Patients with bleeding diathesis and subjects who are receiving anticoagulation treatment with INR > 2 are excluded.
• History of recurrent thrombosis or any thrombosis within the past 6 months
• Family history consistent with thrombophilia or hypofibrinolysis
• Patients who have received liver transplantation
• History of clinically significant liver abnormalities other than liver metastasis

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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