A Phase I Study of Aflibercept Plus FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in Chinese Patients With Advanced Solid Malignancies

Sponsor
Sanofi
Study ID
NCT01930552
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasm Malignant

Eligibility Criteria

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

Interventions

  • Aflibercept AVE0005 — DRUG
    Pharmaceutical form:Solution for infusion Route of administration: Intravenous
  • Leucovorin — DRUG
    Pharmaceutical form:Solution for infusion Route of administration: Intravenous
  • Irinotecan — DRUG
    Pharmaceutical form:Solution for infusion Route of administration: Intravenous
  • 5-Fluorouracil — DRUG
    Pharmaceutical form:Solution for infusion Route of administration: Intravenous

Study Details

Primary Objective: To assess the safety and pharmacokinetics preliminarily of the dose of intravenous (IV) aflibercept used in western studies in combination with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) given intravenously every 2 weeks in Chinese patients with solid tumors. Secondary Objectives: * To make a preliminary assessment of antitumor effects of the combination of FOLFIRI plus aflibercept in patients with measurable disease (RECIST 1.1). * To evaluate the immunogenicity of IV aflibercept.

Key Dates

Start date
Sep 30, 2013
Status verified
Jan 2015
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    aflibercept IV infusion for 1 hour followed by FOLFIRI IV infusion every 2 weeks

Primary Outcome Measure

Number of patients with standard safety assessments (adverse events and laboratory tests) [ Time Frame: Up to last treatment + 30 days ]

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