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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01148615
Other study ID # TCD11382
Secondary ID U1111-1116-5774
Status Completed
Phase Phase 1
First received June 21, 2010
Last updated January 12, 2012
Start date July 2010
Est. completion date December 2011

Study information

Verified date January 2012
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date December 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Aflibercept (AVE0005)
Pharmaceutical form: solution for infusion Route of administration: intravenous
Docetaxel (XRP6976)
Pharmaceutical form: solution for infusion Route of administration: intravenous

Locations

Country Name City State
China Sanofi-Aventis Investigational Site Number 156001 Guangzhou

Sponsors (2)

Lead Sponsor Collaborator
Sanofi Regeneron Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose-Limiting Toxicity (DLT) 3 weeks (cycle 1) No
Secondary Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities Up to 30 days after last administration within a maximum follow up of 18 months Yes
Secondary Pharmacokinetic parameters of aflibercept up to last aflibercept administration +90 days No
Secondary Pharmacokinetic parameters of docetaxel cycle 1 No
Secondary Tumor response rate as calculated by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) up to a maximum follow-up of 18 months No
Secondary Immunogenicity of Aflibercept up to last aflibercept administration+90 days Yes
Secondary Endogenous free VEGF up to last aflibercept administration+30 days No
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