Study of Aflibercept as Maintenance Therapy Following Induction With Aflibercept in Combination With XELOX, as First-Line Treatment for Metastatic Colorectal Cancer Patient

Sponsor
Sanofi
Study ID
NCT01955629
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept AVE0005 — DRUG
    Pharmaceutical form: Concentrate for solution for infusion; Route of administration: Intravenous
  • Oxaliplatin — DRUG
    Pharmaceutical form: Concentrate for solution for infusion; Route of administration: Intravenous
  • Capecitabine — DRUG
    Pharmaceutical form: Tablets; Route of administration: Oral

Study Details

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.

Key Dates

Start date
Dec 31, 2013
Status verified
Mar 2016
Primary completion
Mar 31, 2015
Completion
Mar 31, 2015

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept + XELOX (Oxaliplatin and Capecitabine)
    Aflibercept 6 mg/kg every 3 weeks (q3w) in combination with Oxaliplatin 100 mg/m\^2 q3w and Capecitabine 850 mg/m\^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg q3w as maintenance therapy up to disease progression or unacceptable toxicity or participant's refusal of further treatment.

Primary Outcome Measure

Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (Up to 3 weeks) ]

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