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Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Pancreatic Cancer

NCT02043288 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2020-04-15

No results posted yet for this study

Summary

This clinical trial is designed to evaluate the impact of the addition of NC-6004 to gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic cancer in Asian countries.

Conditions

  • Pancreatic Neoplasms

Interventions

DRUG

NC-6004

Study group (3 week/cycle): NC-6004 90 mg/m2 i.v. inf. over 60 min on Day 1

DRUG

Gemcitabine

Study group (3 week/cycle): Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1 and Day 8 (follow by administration of NC-6004) Control group (4 week/cycle): Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1, Day 8 and Day 15

Sponsors & Collaborators

  • NanoCarrier Co., Ltd.

    collaborator INDUSTRY

  • Orient Europharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Li-Tzong Chen, M.D., Ph. D. · National Institute of Cancer Research, National Health Research Institutes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Hong Kong
  • Japan
  • Malaysia
  • Philippines
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

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 NCT02043288 on ClinicalTrials.gov