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

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00545246
First received: October 16, 2007
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • safety: physical examination, laboratory safety tests, adverse events [ Time Frame: up to 60 days after last treatment ] [ Designated as safety issue: Yes ]
  • pharmacokinetic values [ Time Frame: every 3-week cycle ] [ Designated as safety issue: No ]
  • objective response rate [ Time Frame: every 3-week cycle ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545246

Locations
Japan
Sanofi-Aventis Investigational Site Number 392002
Iruma-gun, Japan, 350-0495
Sanofi-Aventis Investigational Site Number 392001
Sunto-Gun, Japan, 411-8777
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00545246     History of Changes
Other Study ID Numbers: TCD10091
Study First Received: October 16, 2007
Last Updated: November 8, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi:
VEGF Trap

Additional relevant MeSH terms:
Neoplasms
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013