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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Neoplasm Malignant

Treatments: Drug: Aflibercept (AVE0005); Drug: Docetaxel (XRP6976)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01148615

TCD11382

U1111-1116-5774 (Other Identifier)

Details and patient eligibility

About

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)

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Aflibercept/ docetaxel

Experimental group

Description:

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

Treatment:

Drug: Docetaxel (XRP6976)

Drug: Aflibercept (AVE0005)