A Phase I Study of Intravenous Aflibercept in Combination With S-1 in Japanese Cancer Patients

Sponsor
Sanofi
Study ID
NCT00479076
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms

Eligibility Criteria

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

Interventions

Study Details

The primary objective of this study is to determine the recommended phase II dose of AVE0005 in combination with S-1 in Japanese cancer patients. The secondary objectives of this study are to assess the safety profile of AVE0005, to determine the pharmacokinetics of AVE0005, to make a preliminary assessment of antitumor effects.

Key Dates

Start date
Mar 31, 2007
Status verified
Jan 2011
Primary completion
Jan 31, 2011
Completion
Jan 31, 2011

Study Design

Enrollment
22 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Primary Outcome Measure

Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities [ Time Frame: during the first cycle of study treatment ]

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