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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: aflibercept (AVE0005); Drug: docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545246

TCD10091

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

aflibercept + docetaxel

Experimental group

Treatment:

Drug: docetaxel

Drug: aflibercept (AVE0005)