Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Aflibercept

Tubulin Modulators

Antimitotic Agents

Angiogenesis Inhibitors

Growth Inhibitors

aflibercept (AVE0005)

docetaxel

Clinical Sciences & Operations

The primary objective of this study is to determine the dose of aflibercept to be further studied in combination with docetaxel in Japanese cancer patients.

The secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor effects.

A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients

A Phase I, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Docetaxel Administered Every 3 Weeks in Patients With Advanced Solid Malignancies

Regeneron Pharmaceuticals

Sanofi

The primary objective of this study is to determine the recommended phase II dose of AVE0005 in combination with S-1 in Japanese cancer patients.

The secondary objectives of this study are to assess the safety profile of AVE0005, to determine the pharmacokinetics of AVE0005, to make a preliminary assessment of antitumor effects.

A Phase I Study of Intravenous Aflibercept in Combination With S-1 in Japanese Cancer Patients

A Single Agent-combination Hybrid Phase I, Open-label, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous AVE0005 (VEGF Trap)Administered Every 2 Weeks in Combination With Oral S-1 in Patients With Advanced Solid Malignancies

Trial Transparency Team

placebo

The primary objective of this study is to evaluate the effects of aflibercept on the QTc interval in cancer patients.

Secondary objectives are to evaluate the effects of aflibercept on other electrocardiogram (ECG) parameters, clinical safety and pharmakokinetic (PK) parameters.

All patients receive background treatment with docetaxel.

A Study to Evaluate the Effects of Aflibercept on QTc Interval in Cancer Patients

A Randomized, Double-Blind, Placebo-controlled Study Comparing Aflibercept Versus Placebo on the QTc Interval in Cancer Patients Treated With Docetaxel

Pharmaceutical Solutions

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

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Aflibercept (AVE0005)

Docetaxel (XRP6976)

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.

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

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients	NCT00545246	Neoplasms	aflibercept (AV... docetaxel	20 Years -	Sanofi
A Phase I Study of Intravenous Aflibercept in Combination With S-1 in Japanese Cancer Patients	NCT00479076	Neoplasms	aflibercept (AV... S-1	20 Years -	Sanofi
A Study to Evaluate the Effects of Aflibercept on QTc Interval in Cancer Patients	NCT00876044	Cancer	aflibercept (AV... placebo	18 Years -	Sanofi
A Study of Intravenous Aflibercept With Docetaxel in Chinese Patients With Solid Tumors	NCT01148615	Neoplasm Malign...	Aflibercept (AV... Docetaxel (XRP6...	18 Years -	Sanofi
A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients	NCT00545246	Neoplasms	aflibercept (AV... docetaxel	20 Years -	Sanofi
A Study to Evaluate the Effects of Aflibercept on QTc Interval in Cancer Patients	NCT00876044	Cancer	aflibercept (AV... placebo	18 Years -	Sanofi
A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients	NCT00545246	Neoplasms	aflibercept (AV... docetaxel	20 Years -	Sanofi

Spots Global Cancer Trial Database for aflibercept (ave0005)