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

Sanofi20 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoplasm Malignant

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Dose-Limiting Toxicity (DLT)

Time frame: 3 weeks (cycle 1)

Secondary Outcomes

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

Pharmacokinetic parameters of aflibercept

Time frame: up to last aflibercept administration +90 days

Pharmacokinetic parameters of docetaxel

Time frame: cycle 1

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

Immunogenicity of Aflibercept

Time frame: up to last aflibercept administration+90 days

Endogenous free VEGF

Time frame: up to last aflibercept administration+30 days