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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00545246
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 12
• Locations: 2
• Arm: 1
• Duration (Months): 57
• Patients Per Site: 6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Drug: aflibercept (AVE0005); Drug: docetaxel	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: aflibercept + docetaxel	Drug: aflibercept (AVE0005); intravenous infusion; Drug: docetaxel; intravenous infusion

Outcome Measures

Primary Outcome Measures

1. 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

1. safety: physical examination, laboratory safety tests, adverse events [up to 60 days after last treatment]

2. pharmacokinetic values [every 3-week cycle]

3. objective response rate [every 3-week cycle]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Investigational Site Number 392002	Iruma-gun		Japan
2	Sanofi-Aventis Investigational Site Number 392001	Sunto-Gun		Japan

Sponsors and Collaborators

• Sanofi
• Regeneron Pharmaceuticals

Investigators

• Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT00545246
• Other Study ID Numbers: TCD10091
• First Posted: Oct 17, 2007
• Last Update Posted: Oct 16, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Sanofi: VEGF Trap
• Additional relevant MeSH terms: Docetaxel; Aflibercept

Study Results

No Results Posted as of Oct 16, 2013