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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

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

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
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

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

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 ClinicalTrials.gov identifier (NCT number): NCT01148615


Locations
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China
Sanofi-Aventis Investigational Site Number 156001
Guangzhou, China, 510060
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01148615     History of Changes
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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Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action