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Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer

NCT04257448 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-09-30

No results posted yet for this study

Summary

A multi-center, open-label phase I/II study to to determine the safety and tolerability of Azacitidine and/or Romidepsin in combination with nab-Paclitaxel/Gemcitabine in patients with advanced pancreatic ductal adenocarcinoma (PDAC) (Part 1), followed by sequential immune targeting with programmed death-ligand (PD-L)1 blockade in combination with low-dose Lenalidomide (Part 2) in patients with controlled disease after 3 cycles (Part 1).

Conditions

Interventions

DRUG

Romidepsin

Powder and solvent for solution for infusion; Intravenous use

DRUG

Azacitidine

Powder for suspension for injection; Subcutaneous use

DRUG

nab-Paclitaxel

Powder for suspension for injection; Intravenous use

DRUG

Gemcitabine

Powder for solution for infusion; Intravenous use

DRUG

Durvalumab

Concentrate for solution for infusion; Intravenous use

DRUG

Lenalidomide capsule

Hard capsule for oral use

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • GWT-TUD GmbH

    lead OTHER

Principal Investigators

  • Jens Siveke, Prof. Dr. · Institute for Developmental Cancer Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-25
Primary Completion
2024-07-02
Completion
2024-07-02

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT04257448 on ClinicalTrials.gov