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

A Single Agent-combination Hybrid Phase I, Open-label, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous AVE0005 (VEGF Trap)Administered Every 2 Weeks in Combination With Oral S-1 in Patients With Advanced Solid Malignancies

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00479076

Enrollment

Registered

2007-05-25

Start date

2007-03-31

Completion date

2011-01-31

Last updated

2011-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

antineoplastic agents, VEGF Trap

Brief summary

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.

Interventions

DRUGaflibercept (AVE0005)

intravenous infusion

DRUGS-1

oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically confirmed cancer patients without standard of care * ECOG performance status 0, 1, or 2 * Adequate organ and bone marrow function

Exclusion criteria

* Need for a major surgery or radiation therapy during the study * History of hypersensitivity to S-1 * Known dihydropyrimidine dehydrogenase deficiency * Uncontrolled hypertension * History of brain metastases * Ascites requiring drainage * Pregnancy or breastfeeding * Patients who have previously been treated with AVE0005 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Design outcomes

Primary

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

Secondary

Measure	Time frame
safety: physical examination, laboratory safety tests, adverse events	treatment period
pharmacokinetic values	treatment period
objective response rate	treatment period

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026