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

NCT02417753 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-05-15

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

AZD9150

AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Tim F Greten, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-03
Primary Completion
2016-04-07
Completion
2016-04-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02417753 on ClinicalTrials.gov