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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545246
• Other study ID #: TCD10091
• Status: Completed
• Phase: Phase 1
• First received: October 16, 2007
• Last updated: October 12, 2013
• Start date: October 2007
• Est. completion date: July 2012

Study information

• Verified date: October 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• aflibercept (AVE0005)
intravenous infusion
• docetaxel
intravenous infusion

Locations

Country	Name	City	State
Japan	Sanofi-Aventis Investigational Site Number 392002	Iruma-gun
Japan	Sanofi-Aventis Investigational Site Number 392001	Sunto-Gun

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities		first 3-week cycle	Yes
Secondary	safety: physical examination, laboratory safety tests, adverse events		up to 60 days after last treatment	Yes
Secondary	pharmacokinetic values		every 3-week cycle	No
Secondary	objective response rate		every 3-week cycle	No