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Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer

NCT04163900 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 773

Last updated 2023-05-24

Study results available
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Summary

NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer.

The primary hypotheses are:

* The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care
* The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care

Conditions

  • Biliary Tract Cancer

Interventions

DRUG

NUC-1031

IV infusion in 500 mL of 0.9% sterile saline for injection given over 30 minutes

DRUG

Gemcitabine

IV infusion in 250 mL of 0.9% sterile saline for injection given in accordance with the package insert

DRUG

Cisplatin

IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol

Sponsors & Collaborators

  • NuCana plc

    lead OTHER

Principal Investigators

  • Jennifer Knox, MD · Professor of Medicine, University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-24
Primary Completion
2022-03-02
Completion
2022-04-05
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

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 NCT04163900 on ClinicalTrials.gov