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Completed

NCT Number: NCT01148615

A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors

Primary Objective:

* To confirm the dose of aflibercept in western studies by assessing the dose-limiting toxicity (DLT) of intravenous (IV) aflibercept when administered in combination with docetaxel given intravenously every 3 weeks in Chinese patients with solid tumors.

Secondary Objectives:

* To assess the safety profile of intravenous (IV) aflibercept when administered in combination with docetaxel * To determine the pharmacokinetics of IV aflibercept and docetaxel when administered in combination * To make a preliminary assessment of antitumor effects of the combination of docetaxel plus aflibercept in patients with evaluable disease * To evaluate the immunogenicity of IV aflibercept * To measure endogenous free Vascular Endothelial Growth Factor (VEGF)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sanofi-Aventis Investigational Site Number 156001

Guangzhou, 510060, China

About this study

The duration of screening, treatment, and follow-up are within 21 days, 3 weeks/cycle, and 90 days after the last aflibercept administration. Patients will be administered aflibercept in combination with docetaxel until when/if a definitive treatment discontinuation criterion is met such as progressive disease, unacceptable toxicity or patient refusal to continue.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically or cytologically confirmed solid malignancy that metastatic or unresectable for which standard curative measures do not exist, but for which docetaxel treatment is appropriate.

Exclusion criteria

  • Squamous histology/cytology lung cancer
  • Need for a major surgical procedure or radiation therapy during the study
  • Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an investigational agent within 28 days
  • Cumulative radiation therapy to >25% of the total bone marrow
  • History of brain metastases
  • Eastern Cooperative Oncology Group(ECOG)>1
  • Prior docetaxel treatment but have not been appropriate for safety reasons
  • Inadequate organ and bone marrow function
  • Uncontrolled hypertension
  • Evidence of clinically significant bleeding diathesis or underlying coagulopathy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Aflibercept (AVE0005)

Drug

Pharmaceutical form: solution for infusion

Route of administration: intravenous

docetaxel (XRP6976)

Drug

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Primary outcomes

  1. Dose-Limiting Toxicity (DLT)

    Time frame: 3 weeks (cycle 1)

Secondary outcomes

  1. Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities

    Time frame: Up to 30 days after last administration within a maximum follow up of 18 months

  2. Pharmacokinetic parameters of aflibercept

    Time frame: up to last aflibercept administration +90 days

  3. Pharmacokinetic parameters of docetaxel

    Time frame: cycle 1

  4. Tumor response rate as calculated by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Time frame: up to a maximum follow-up of 18 months

  5. Immunogenicity of Aflibercept

    Time frame: up to last aflibercept administration+90 days

  6. Endogenous free VEGF

    Time frame: up to last aflibercept administration+30 days

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 Administrated Every 3 Weeks in Chinese Patients With Advanced Solid Malignancies

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 22, 2010
Registry last updated
Jan 13, 2012

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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