A Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (INTEGRATEII)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02773524|
Recruitment Status : Recruiting
First Posted : May 16, 2016
Last Update Posted : April 11, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastro-Oesophageal Cancer||Drug: Regorafenib Other: Placebo||Phase 3|
|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 :||May 2020|
|Estimated Study Completion Date :||December 2021|
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.
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 predict outcomes [ Time Frame: Up to 24 months following close of recruitment. ]
- Evaluation of regorafenib pharmacokinetics in patients from different geographical regions [ Time Frame: Up to 24 months following close of recruitment. ]
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