Colorectal Cancer Treated With Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo‑Controlled Phase-III STudy (COAST)
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|ClinicalTrials.gov Identifier: NCT01939223|
Recruitment Status : Terminated
First Posted : September 11, 2013
Results First Posted : October 20, 2017
Last Update Posted : October 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Drug: Regorafenib (Stivarga, BAY73-4506) Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled Phase-III Study of Adjuvant Regorafenib Versus Placebo for Patients With Stage IV Colorectal Cancer After Curative Treatment of Liver Metastases|
|Actual Study Start Date :||December 2, 2013|
|Actual Primary Completion Date :||August 29, 2016|
|Actual Study Completion Date :||August 29, 2016|
4 regorafenib tablets taken orally in the morning daily, followed by a low fat meal for 3 weeks on off treatment followed by 1 week off without treatment,Treatment 21 days.
Drug: Regorafenib (Stivarga, BAY73-4506)
Four tablets of 40mg taken orally daily in the morning, dose of 160 mg for 21 days of treatment followed by 7 days without treatment
Placebo Comparator: Placebo
4 placebo tablets taken orally in the morning daily,followed by a low fat meal for 3 weeks on off treatment followed by 1 week off without treatment,Treatment 21 days.
Four tablets taken in the morning orally daily for 21 days of treatment followed by 7 days without treatment
- Disease Free Survival (DFS) as Assessed by the Investigator [ Time Frame: From date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented. ]Disease free survival was evaluated by CT / MRI scans as assessed by the investigator, which was defined as the time (in days) from date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented. For subjects without documented disease recurrence or death at the time of analysis, the DFS time was censored at the date of the last evaluable CT / MRI scan.
- Overall Survival (OS) [ Time Frame: Subjects who experienced disease recurrence (either during treatment or during Active Follow-up), or otherwise withdrew from the study for any reason other than death, were followed for overall survival unless consent was withdrawn. ]Overall survival (OS) is defined as the time (days) from randomization to death due to any cause. The OS time for subjects alive at the time of analysis was censored at their last date known to be alive.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939223
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|Study Director:||Bayer Study Director||Bayer|