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

A Phase I, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Docetaxel Administered Every 3 Weeks in Patients With Advanced Solid Malignancies

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00545246

Enrollment

Registered

2007-10-17

Start date

2007-10-31

Completion date

2012-07-31

Last updated

2013-10-16

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

Conditions

Neoplasms

Keywords

VEGF Trap

Brief summary

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.

Interventions

DRUGaflibercept (AVE0005)

intravenous infusion

DRUGdocetaxel

intravenous infusion

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

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 or 1 * Adequate organ and bone marrow function

Exclusion criteria

* Need for a major surgery or radiation therapy during the study * History of hypersensitivity to docetaxel or polysorbate 80 * Treatment with chemotherapy, hormonal therapy, radiotherapy within 28 days * Uncontrolled hypertension * History of brain metastases * Ascites requiring drainage * Pregnancy or breastfeeding * Patients who have previously been treated with aflibercept. The investigator will evaluate whether there are other reasons why a patient may not participate.

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	first 3-week cycle

Secondary

Measure	Time frame
safety: physical examination, laboratory safety tests, adverse events	up to 60 days after last treatment
pharmacokinetic values	every 3-week cycle
objective response rate	every 3-week cycle

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026