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A Single-Arm, Open Label Study of Aflibercept as Maintenance Therapy Following Induction With Aflibercept in Combination With XELOX, as First-Line Treatment for Metastatic Colorectal Cancer Patient (AMOR)
Primary Objectives: Study Part 1: To determine the recommended dose for the aflibercept, oxaliplatin and capecitabine (XELOX) combination to be used in the Part 2 of the study. Study Part 2: To assess the percentage of participants without progression of the disease at 6 months after the start of maintenance therapy with aflibercept single-agent, following the first-line induction therapy with XELOX and aflibercept combination in participants with previously untreated metastatic colorectal cancer. Secondary Objective: Study Part 2: Include the evaluation of progression free survival, overall survival, response to treatment, the overall safety (during induction and maintenance therapy) and the assessment of aflibercept pharmacodynamics and biomarkers parameters.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | TERMINATED |
| Enrolment | 4 |
| Start date | 2013-12 |
| Completion | 2015-03 |
Conditions
- Colorectal Cancer Metastatic
Interventions
- Aflibercept AVE0005
- Oxaliplatin
- Capecitabine
Primary outcomes
- Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) — Cycle 1 (Up to 3 weeks)
DLTs were assessed using the national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 4.03. DLTs were defined as any of following AEs: grade 4 neutropenia lasting \>7 consecutive days; febrile neutropenia or neutropenic infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia associated with bleeding requiring transfusion; grade 4 non-hematological treatment related event; grade 3 nausea/vomiting or diarrhea lasting \>/= 4 days despite corrective measures; grade 3 other non-hematological toxicities: anorexia, fatigue, hypertension only if G4 or not medically controlled and G3 peripheral sensory neuropathy that did not improve to G\<2 at time of retreatment; urinary protein excretion of \>3.5 gram per 24 hours that did not recover to \<2.0 gram per 24 hours within 2 weeks; symptomatic arterial thromboembolic events including cerebrovascular accidents, myocardial infarction, transient ischemic attacks, new onset or worsening of pre-existing angina. - Part 2: Number of Participants With Progression Free Survival (PFS) at 6 Months After the Start of Maintenance Therapy — 6 months after the start of maintenance therapy.
It describes the number of participants alive without progression at 6 months after the start of Aflibercept maintenance therapy.
Countries
Italy