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Trial record 1 of 1 for:    tcd11382
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A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors

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. Identifier: NCT01148615
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : January 13, 2012
Regeneron Pharmaceuticals
Information provided by (Responsible Party):

Brief Summary:

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)

Condition or disease Intervention/treatment Phase
Neoplasm Malignant Drug: Aflibercept (AVE0005) Drug: Docetaxel (XRP6976) Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
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 Administrated Every 3 Weeks in Chinese Patients With Advanced Solid Malignancies
Study Start Date : July 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Aflibercept/ docetaxel

Patients with advanced cancer will receive different doses of aflibercept in combination with approved dose of docetaxel.

Aflibercept 4 or 6mg/kg over 1 hour IV immediately followed by Docetaxel 75mg/m2 IV over 1 hour on Day 1, every 3 weeks

Drug: Aflibercept (AVE0005)

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Drug: Docetaxel (XRP6976)

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Primary Outcome Measures :
  1. Dose-Limiting Toxicity (DLT) [ Time Frame: 3 weeks (cycle 1) ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01148615

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Sanofi-Aventis Investigational Site Number 156001
Guangzhou, China, 510060
Sponsors and Collaborators
Regeneron Pharmaceuticals
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Study Director: Clinical Sciences & Operations Sanofi
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sanofi Identifier: NCT01148615    
Other Study ID Numbers: TCD11382
U1111-1116-5774 ( Other Identifier: UTN )
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: January 13, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors