Regorafenib Assessment in Refractory Advanced Colorectal Cancer(RegARd-C) (RegARd-C)
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ClinicalTrials.gov Identifier: NCT01929616 |
Recruitment Status :
Completed
First Posted : August 28, 2013
Last Update Posted : June 25, 2019
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Sponsor:
Jules Bordet Institute
Information provided by (Responsible Party):
Jules Bordet Institute
Tracking Information | ||||
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First Submitted Date ICMJE | July 28, 2013 | |||
First Posted Date ICMJE | August 28, 2013 | |||
Last Update Posted Date | June 25, 2019 | |||
Study Start Date ICMJE | August 2013 | |||
Actual Primary Completion Date | May 13, 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall survival (OS) [ Time Frame: 2 years from first patient in ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Regorafenib Assessment in Refractory Advanced Colorectal Cancer(RegARd-C) | |||
Official Title ICMJE | Regorafenib Assessment in Refractory Advanced Colorectal Cancer | |||
Brief Summary | The general objectives are to evaluate activity and the safety of regorafenib in a population of patients bearing advanced, refractory colorectal cancers and to explore the different downstream molecular pathways to identify tumor response and resistance mechanisms. | |||
Detailed Description | The primary objective is to identify in a population of patients bearing advanced, refractory colorectal cancers, those who draw no benefit from treatment with regorafenib. There is no specific hypothesis underlying sample size and the study is therefore to be seen as exploratory. Secondary objectives:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Chemorefractory Colorectal Adenocarcinoma | |||
Intervention ICMJE | Drug: regorafenib
Patients will receive 160 mg regorafenib 1/day 3 weeks out of 4.
Other Name: stivarga (registred name)
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Study Arms ICMJE | Experimental: Regorafenib
A treatment cycle is defined as a 4 weeks period. Regorafenib will be administered once a day orally at a dose of 160 mg (4 tablets of 40 mg), for 3 weeks.
Intervention: Drug: regorafenib
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
141 | |||
Original Estimated Enrollment ICMJE |
124 | |||
Actual Study Completion Date ICMJE | June 17, 2019 | |||
Actual Primary Completion Date | May 13, 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01929616 | |||
Other Study ID Numbers ICMJE | 2012-005655-16 EUDRACT | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Jules Bordet Institute | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Jules Bordet Institute | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Jules Bordet Institute | |||
Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |