A Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer

Phase 3

• Conditions: Gastro-Oesophageal Cancer
• Interventions: Other: Placebo; Drug: Regorafenib

• Registration Number: NCT02773524
• Lead Sponsor: Australasian Gastro-Intestinal Trials Group

Brief 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.

Study Timeline

• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-16
• Study Start: 2016-11
• Status Verified: 2022-01
• Primary Completion: 2022-01
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-13
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 160mg (4 x 40 mg tablets) orally, once daily on days 1-21 of each 28 day cycle + best supportive care until progression
Regorafenib	Regorafenib	Regorafenib 160mg (4 x 40 mg tablets) orally, once daily on days 1-21 of each 28 day cycle + best supportive care until progression

Primary Outcome Measures

Name	Time	Method
Overall Survival	From time of patient randomisation until date last known alive (up to 12 months following end of treatment).	The interval from the date of randomisation to date of death from any cause, or the date last known alive.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	From time of patient randomisation until first evidence of disease progression or death (up to 12 months following randomisation).	The interval from the date of randomisation to the date of first evidence of disease progression or death, whichever occurs first.
Evaluation of health states experienced by participants	From time of commencement of treatment until first evidence of disease progression (up to 12 months following commencement of treatment).	Questionnaire used to assess quality of life
Objective Tumour Response Rate	From time of patient randomisation until evidence of complete or partial response (up to 12 months following randomisation).	The OTRR will be calculated by summing the number of participants in a given arm that are assessed as having a complete or partial response (as per RECIST criteria), and dividing this by the total number of participants in the corresponding arm of the analysis set.
Rates of Adverse Events	From time dose of study treatment until 30 days after last dose of study treatment	A descriptive analysis of the adverse events (AE) data will be prepared for participants in the safety population. The number and percentage of participants who experience AEs will be tabulated according to CTCAE term/category, grade, and seriousness.

Trial Locations

Locations (60)

Mayo Clinic Arizona; 🇺🇸 Scottsdale, Arizona, United States

USC Norris; 🇺🇸 Los Angeles, California, United States

Carle Cancer Center NCI Community Oncology Research Program; 🇺🇸 Urbana, Illinois, United States

Bon Secours Cancer Institute; 🇺🇸 Midlothian, Virginia, United States

Canberra Hospital; 🇦🇺 Canberra, Australian Capital Territory, Australia

Border Medical Oncology; 🇦🇺 Albury, New South Wales, Australia

Monash Medical Centre; 🇦🇺 Clayton, New South Wales, Australia

Coffs Harbour Health Campus; 🇦🇺 Coffs Harbour, New South Wales, Australia

Concord Repatriation General Hospital; 🇦🇺 Concord, New South Wales, Australia

St Vincent's Public Hospital; 🇦🇺 Darlinghurst, New South Wales, Australia

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