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Acelarin First Line Randomised Pancreatic Study

NCT03610100 · Status: SUSPENDED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 328

Last updated 2019-10-29

No results posted yet for this study

Summary

The primary purpose of this study is to assess whether Acelarin (NUC-1031) is superior to gemcitabine in terms of overall survival for treatment of patients with metastatic pancreatic carcinoma. In addition disease progression, quality of life and comparative safety will be evaluated. Secondary objectives are to compare between the two treatment groups the following:

* Progression Free Survival (PFS)
* Radiological Response and disease control rate
* Toxicity and safety
* Quality of Life

Additional, exploratory objectives are to discover and validate possible biomarkers to predict additional benefit of Acelarin (NUC-1031) over gemcitabine alone.

Conditions

  • Pancreatic Acinar Carcinoma
  • Pancreatic Neoplasms

Interventions

DRUG

Acelarin

825 mg/m2 administered intravenously over 15 to 30 minutes on days 1, 8 and 15 of a 28 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.

DRUG

Gemcitabine

1000 mg/m2 administered intravenously as a 30 minute infusion on days 1, 8 and 15 of a 28 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.

Sponsors & Collaborators

  • Cancer Research UK

    collaborator OTHER

  • University of Liverpool

    collaborator OTHER

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Daniel H Palmer, BSC, PhD · University of Liverpool

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2020-09-30
Completion
2022-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT03610100 on ClinicalTrials.gov