A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy
Phase 2
Completed
NCT02743221
| Condition | Metastatic Colorectal Cancer |
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| Phase | Phase 2 |
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| Sponsor | Institut de Recherches Internationales Servier |
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| Status | Completed |
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| Enrollment | 154 participants |
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| Interventions | Trifluridine/tipiracil + bevacizumab, Capecitabine + bevacizumab |
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| Start date | Apr 29, 2016 |
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| Completion date | Jan 15, 2018 |
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| Results posted | Apr 16, 2019 |
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Summary
The main purpose of this study is to evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.
Progression Free Survival (PFS)
Baseline and every 8 weeks (maximum follow-up duration: 17.9 months) · months
| Trifluridine/Tipiracil + Bevacizumab | 9.2 months |
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| Capecitabine + Bevacizumab | 7.8 months |
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| p-value | 0.09 |
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| Hazard Ratio (HR) | 0.71 (95% CI 0.48–1.06) |
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Open in BENITIONS
View on ClinicalTrials.gov
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