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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00545246
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : October 16, 2013
Regeneron Pharmaceuticals
Information provided by (Responsible Party):

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 Type : Interventional  (Clinical Trial)
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 : October 2007
Primary Completion Date : July 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 :
  1. safety: physical examination, laboratory safety tests, adverse events [ Time Frame: up to 60 days after last treatment ]
  2. pharmacokinetic values [ Time Frame: every 3-week cycle ]
  3. objective response rate [ Time Frame: every 3-week cycle ]

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00545246     History of Changes
Other Study ID Numbers: TCD10091
First Posted: October 17, 2007    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action