NCT02773524

A Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer

A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Australasian Gastro-Intestinal Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Purpose: The purpose of this Phase III study is to determine if regorafenib improves overall survival in patients with Advanced Gastro-Oesophageal Carcinoma. Who is it for: You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) Gastro-Oesophageal Carcinoma which has not responded to a minimum of 2 lines of prior anti-cancer therapy. Trial Details: Participants will be randomly (by chance) allocated to one of two groups: regorafenib or placebo in 2:1 ratio respectively and will not be aware of their group allocation. Regorafenib or matching placebo will be self-administered by participants orally once daily on days 1-21 of each 28 days cycle. Treatment will continue until disease progression or prohibitive toxicity. Participants will be followed up every 2-4 weeks in order to evaluate their progress on the study.

Conditions

• Gastro-Oesophageal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2022-01-01
• Completion: 2022-12-01
• First posted: 2016-05-16
• Last updated: 2022-01-13

Locations

60 sites across 7 countries: United States, Australia, Canada, Japan, New Zealand, South Korea, Taiwan

Regulatory

• FDA-regulated drug study