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

This study has been completed.
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi Identifier:
First received: October 16, 2007
Last updated: October 12, 2013
Last verified: October 2013

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 Intervention Phase
Drug: aflibercept (AVE0005)
Drug: docetaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities [ Time Frame: first 3-week cycle ]

Secondary Outcome Measures:
  • safety: physical examination, laboratory safety tests, adverse events [ Time Frame: up to 60 days after last treatment ]
  • pharmacokinetic values [ Time Frame: every 3-week cycle ]
  • objective response rate [ Time Frame: every 3-week cycle ]

Enrollment: 12
Study Start Date: October 2007
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aflibercept + docetaxel Drug: aflibercept (AVE0005)
intravenous infusion
Drug: docetaxel
intravenous infusion


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00545246

Sanofi-Aventis Investigational Site Number 392002
Iruma-gun, Japan
Sanofi-Aventis Investigational Site Number 392001
Sunto-Gun, Japan
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT00545246     History of Changes
Other Study ID Numbers: TCD10091
Study First Received: October 16, 2007
Last Updated: October 12, 2013

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on March 27, 2017