A Study of Aflibercept in Combination With FOLFIRI in Patients With Second-Line Metastatic Colorectal Cancer in Japan

Sponsor
Sanofi
Study ID
NCT01882868
Phase
PHASE2
Status
Completed

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

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

Interventions

  • Aflibercept — DRUG
    Pharmaceutical form: Concentrated solution (100 mg/4 mL \[25 mg/mL\], 200 mg/8 mL \[25 mg/mL\]) for infusion; Route of administration: Intravenous
  • Levofolinate — DRUG
    Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous
  • Irinotecan — DRUG
    Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous
  • 5-FU — DRUG
    Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous

Study Details

Primary Objective: To assess efficacy aflibercept + 5-fluorouracil (5-FU)/levofolinate/irinotecan (FOLFIRI) by objective response rate (ORR). Secondary Objective: To assess the following: * safety profile; * progression free survival (PFS); * overall survival (OS); * pharmacokinetics (PK); * immunogenicity.

Key Dates

Start date
Jul 31, 2013
Status verified
Aug 2016
Primary completion
Aug 31, 2015
Completion
Aug 31, 2015

Study Design

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

Arms

  • Experimental: Aflibercept + FOLFIRI
    Aflibercept 4 mg/kg intravenous (IV) infusion (1-2 hours) on Day 1 of Cycle 1 and every 2 weeks (q2w) thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until disease progression (DP), unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m\^2 (2 hours) and irinotecan 180 mg/m\^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m\^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m\^2.

Primary Outcome Measure

Percentage of Participants With Overall Response [ Time Frame: Baseline and every 6 weeks until DP (maximum duration: 16.4 months) ]

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