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Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 in Patients With Solid Tumors

2014-08-27 03:19:38 | BioPortfolio

Summary

Primary objective: To determine the maximum tolerated dose based on the incidence of dose limiting toxicity and the maximum administered dose of AVE8062 administered every 3 weeks in patients with advanced solid tumors.

Secondary objectives:

- To assess the overall safety profile of the drug.

- To characterize the pharmacokinetic profile of AVE8062 and its active metabolite RPR 258063.

- To evaluate anti-tumor activity of the drug.

Description

The duration of the study for each patient will include an up to 4-week screening phase, 21-day study treatment cycles, an end of treatment visit and a follow-up period.

Study Design

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

Conditions

Solid Tumor

Intervention

ombrabulin (AVE8062)

Location

Sanofi-Aventis Administrative Office
Tokyo
Japan

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:38-0400

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Medical and Biotech [MESH] Definitions

A transplantable, poorly differentiated malignant tumor which appeared originally as a spontaneous breast carcinoma in a mouse. It grows in both solid and ascitic forms.

A malignant cystic or semisolid tumor most often occurring in the ovary. Rarely, one is solid. This tumor may develop from a mucinous cystadenoma, or it may be malignant at the onset. The cysts are lined with tall columnar epithelial cells; in others, the epithelium consists of many layers of cells that have lost normal structure entirely. In the more undifferentiated tumors, one may see sheets and nests of tumor cells that have very little resemblance to the parent structure. (Hughes, Obstetric-Gynecologic Terminology, 1972, p184)

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