Study of Intravenous Aflibercept in Combination With FOLFIRI in Japanese Patients With Metastatic Colorectal Cancer

Sponsor
Sanofi
Study ID
NCT00921661
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The primary objective is to determine the dose of aflibercept to be further studied in combination with irinotecan/5-fluorouracil/isovorin (FOLFIRI) in Japanese patients with metastatic colorectal cancer. Secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor effects.

Key Dates

Start date
Jun 30, 2009
Status verified
Nov 2012
Primary completion
Jun 30, 2012
Completion
Jun 30, 2012

Study Design

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

Arms

  • Experimental: AVE0005 (aflibercept)

Primary Outcome Measure

Dose-limiting toxicity (DLT) combination with FOLFIRI [ Time Frame: During the first 2 cycles (4 weeks) of study treatment ]

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