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A Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer

NCT02773524 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2022-01-13

No results posted yet for this study

Summary

A randomised phase III, double-blind, placebo-controlled trial with 2:1 (regorafenib : placebo)

Conditions

  • Gastro-Oesophageal Cancer

Interventions

DRUG

Regorafenib

Regorafenib is the experimental intervention in this study. Regorafenib will be self-administered by participants at 160mg (4 x 40mg tablets) orally once daily on days 1-21 of each 28 day cycle plus best supportive care until progression or prohibitive toxicity as defined by the protocol.

OTHER

Placebo

Placebo (matching in appearance to regorafenib) made of microcrystalline cellulose, will be self-administered by participants at 160mg (4 x 40mg tablets) orally once daily on days 1-21 of each 28 day cycle plus best supportive care until progression or prohibitive toxicity as defined by the protocol.

Sponsors & Collaborators

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • Academic and Community Cancer Research United

    collaborator OTHER

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Australasian Gastro-Intestinal Trials Group

    lead NETWORK

Principal Investigators

  • Nick Pavlakis, Prof · AGITG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2022-01-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Japan
  • New Zealand
  • 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 NCT02773524 on ClinicalTrials.gov