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

Neoplasm Malignant Clinical Trial

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

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

• Neoplasm Malignant
• Neoplasms

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