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NCT Number: NCT00545246

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

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.

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Key information

Conditions

Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sanofi-Aventis Investigational Site Number 392002, Iruma-gun, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aflibercept (AVE0005)

Drug

intravenous infusion

docetaxel

Drug

intravenous infusion

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Oct 17, 2007
Registry last updated
Oct 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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