A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients

Sponsor
Sanofi
Study ID
NCT00545246
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 dose of aflibercept to be further studied in combination with docetaxel in Japanese cancer patients. The 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
Oct 31, 2007
Status verified
Oct 2013
Primary completion
Jul 31, 2012
Completion
Jul 31, 2012

Study Design

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

Arms

  • Experimental: aflibercept + docetaxel

Primary Outcome Measure

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

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