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

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT03257761
Phase
PHASE1
Status
Active Not Recruiting

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — BIOLOGICAL
    Given IV
  • Guadecitabine — DRUG
    Given SC

Study Details

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.

Key Dates

Start date
Feb 7, 2018
Status verified
May 2026
Primary completion
Sep 27, 2021
Completion
Dec 31, 2026

Study Design

Enrollment
55 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (guadecitabine, durvalumab)
    Patients receive guadecitabine SC QD on days 1-5 and durvalumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 56 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-

Find similar trials in Los Angeles, CA

By research site
USC / Norris Comprehensive Cancer Center· Los Angeles, CAHoag Memorial Hospital Presbyterian· Newport Beach, CAJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MD

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