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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03257761
Other study ID # 0S-16-18
Secondary ID NCI-2017-014320S
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date February 7, 2018
Est. completion date June 2, 2024

Study information

Verified date January 2024
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase Ib trial studies the side effects and best dose of guadecitabine and how well it works when given together with durvalumab in treating patients with liver, pancreatic, bile duct, or gallbladder cancer that has spread to other places in the body. Guadecitabine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as durvalumab, may block tumor growth in different ways by targeting certain cells. Giving guadecitabine and durvalumab may work better in treating patients with liver, pancreatic, bile duct, or gallbladder cancer.


Description:

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Study Design


Related Conditions & MeSH terms

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Intervention

Biological:
Durvalumab
Given IV
Drug:
Guadecitabine
Given SC

Locations

Country Name City State
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Hoag Memorial Hospital Presbyterian Newport Beach California

Sponsors (3)

Lead Sponsor Collaborator
University of Southern California National Cancer Institute (NCI), Van Andel Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events Graded according to Common Terminology Criteria for Adverse Events version 4.03. Up to 56 days
Primary Tumor response (dose expansion) Will be calculated by the percentage of patients having complete or partial response among all patients who have been treated at maximum tolerated dose/recommended phase II dose in each cohort. Will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST). Up to 2 years
Secondary Overall survival Kaplan-Meier curves will be used to show overall survival in each cohort. Median overall survival and 95% confidence intervals will be derived from Kaplan-Meier curves. From start of treatment until death due to any cause, assessed up to 2 years
Secondary Progression-free survival Kaplan-Meier curves will be used to show progression-free survival in each cohort. Median progression-free survival and 95% confidence intervals will be derived from Kaplan-Meier curves. From start of treatment to time of progression per RECIST 1.1 or death whichever comes first, assessed up to 2 years
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