drugset / Trial / NCT03279289
Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Population With mCRC After Failure of an Oxaliplatin-based Regimen
Phase 2
Completed
170 enrolled
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Sanofi · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the efficacy and safety of treatment with FOLFIRI-aflibercept compared to initial treatment with FOLFIRI-aflibercept (for 6 cycles) followed by maintenance with 5FU-aflibercept, in an elderly population with metastatic colorectal cancer (mCRC) after failure of an oxaliplatin-based regimen
Timeline
- Start
- 2017-10-25
- Primary completion
- 2023-02-09
- Completion
- 2023-02-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |
| Subject | folinic acid (dl racemic) | Unknown | 400 mg/m2 | Intravenous |
| Background | Aflibercept | Protein / enzyme biologic | 4 mg/kg | Intravenous |