Guadecitabine and Durvalumab in Treating Patients With Advanced Liver, Pancreatic, Bile Duct, or Gallbladder Cancer

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.

Conditions

• Extrahepatic Bile Duct Adenocarcinoma, Biliary Type
• Gallbladder Adenocarcinoma, Biliary Type
• Metastatic Pancreatic Adenocarcinoma
• Recurrent Cholangiocarcinoma
• Recurrent Gallbladder Carcinoma
• Recurrent Hepatocellular Carcinoma
• Recurrent Intrahepatic Cholangiocarcinoma
• Recurrent Pancreatic Carcinoma
• Stage III Gallbladder Cancer AJCC V7
• Stage III Hepatocellular Carcinoma AJCC v7
• Stage III Intrahepatic Cholangiocarcinoma AJCC v7
• Stage III Pancreatic Cancer AJCC v6 and v7
• Stage IIIA Gallbladder Cancer AJCC v7
• Stage IIIA Hepatocellular Carcinoma AJCC v7
• Stage IIIB Gallbladder Cancer AJCC v7
• Stage IIIB Hepatocellular Carcinoma AJCC v7
• Stage IIIC Hepatocellular Carcinoma AJCC v7
• Stage IV Gallbladder Cancer AJCC v7
• Stage IV Hepatocellular Carcinoma AJCC v7
• Stage IV Pancreatic Cancer AJCC v6 and v7
• Stage IVA Gallbladder Cancer AJCC v7
• Stage IVA Hepatocellular Carcinoma AJCC v7
• Stage IVA Intrahepatic Cholangiocarcinoma AJCC v7
• Stage IVB Gallbladder Cancer AJCC v7
• Stage IVB Hepatocellular Carcinoma AJCC v7
• Stage IVB Intrahepatic Cholangiocarcinoma AJCC v7
• Unresectable Gallbladder Carcinoma
• Unresectable Pancreatic Carcinoma

Interventions

DRUG

Guadecitabine

Given SC

BIOLOGICAL

Durvalumab

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Van Andel Research Institute

  collaborator OTHER

• University of Southern California

  lead OTHER

Principal Investigators

• Anthony El-Khoueiry, MD · University of Southern California

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-07

Primary Completion

2021-09-27

Completion

2026-07-31

FDA Drug

Yes

Countries

• United States

Study Locations