A Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (INTEGRATEIIa)
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|ClinicalTrials.gov Identifier: NCT02773524|
Recruitment Status : Recruiting
First Posted : May 16, 2016
Last Update Posted : May 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Gastro-Oesophageal Cancer||Drug: Regorafenib Other: Placebo||Phase 3|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)|
|Actual Study Start Date :||November 2016|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||December 2022|
Regorafenib 160mg (4 x 40 mg tablets) orally, once daily on days 1-21 of each 28 day cycle + best supportive care until progression
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 Name: Stivarga
Placebo Comparator: 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
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.
- Overall Survival [ Time Frame: 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.
- Progression Free Survival [ Time Frame: 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.
- Objective Tumour Response Rate [ Time Frame: 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.
- Evaluation of health states experienced by participants [ Time Frame: 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
- Rates of Adverse Events [ Time Frame: 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.
- Identification of tumour markers to that predict treatment outcomes for AGOC [ Time Frame: Up to 24 months following close of recruitment. ]Biomarker assessment, CTC DNA assessment to predict whether treatment for AGOC is efficacious
- Evaluation of regorafenib Maximum Plasma Concentration [Cmax] between Asia and Rest of World cohorts. [ Time Frame: Up to 24 months following close of recruitment. ]Evaluation of regorafenib Maximum Plasma Concentration [Cmax] in patients from either Asia or ROW to assess whether genetic factors aide/hinder metabolic rate of consumption of regorafenib
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773524
|Contact: INTEGRATE II Mailboxfirstname.lastname@example.org|
|Study Chair:||Nick Pavlakis, Prof||AGITG|