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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: aflibercept (AVE0005); Drug: docetaxel

• Registration Number: NCT00545246
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-16
• Study First Posted: 2007-10-17
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-12
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
aflibercept + docetaxel	aflibercept (AVE0005)	-
aflibercept + docetaxel	docetaxel	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Sanofi-Aventis Investigational Site Number 392001; 🇯🇵 Sunto-Gun, Japan

Sanofi-Aventis Investigational Site Number 392002; 🇯🇵 Iruma-gun, Japan