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EndoTAG-1+GEM vs GEM in Patients With Locally Advanced/Metastatic Pancreatic Adenocarcinoma Failed on FOLFIRINOX

NCT03126435 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2023-05-06

Study results available
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Summary

The aim of this adaptive Phase 3 trial is to show a statistically significant superiority of EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients with locally advanced/metastatic pancreatic cancer after FOLFIRINOX failure.

Conditions

Interventions

DRUG

EndoTAG-1

twice weekly

DRUG

Gemcitabine

once weekly

Sponsors & Collaborators

  • SynCore Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Li-Tzong Chen, M.D., Ph.D. · National Cheng Kung University Hospital,Tainan, Taiwan, R.O.C

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2021-07-30
Completion
2021-10-08
FDA Drug
Yes

Countries

  • United States
  • France
  • Hungary
  • Israel
  • Russia
  • South Korea
  • Taiwan

Study Locations

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Entities

Drugs
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 NCT03126435 on ClinicalTrials.gov