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- To determine the maximum tolerated dose based on the incidence of dose limiting toxicity and the maximum administered dose of ombrabulin in combination with docetaxel and cisplatin administered every 3 weeks in patients with advanced solid tumors
- To assess the overall safety profile of the combination therapy
- To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR 258063, docetaxel and cisplatin in combination.
- To evaluate anti-tumor activity of the combination therapy
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 30 days after the last infusion of ombrabulin. The patient will continue treatment until disease progression, unacceptable toxicity, patient's refusal of further treatment.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
OMBRABULIN (AVE8062), cisplatin, docetaxel
Sanofi-Aventis Administrative Office
Published on BioPortfolio: 2014-08-27T03:14:53-0400
Primary Objective: - To determine the maximum tolerated dose based on the incidence of dose limiting toxicity and the maximum administered dose of ombrabulin in combination with c...
The purpose of this study is to determine the recommended dose of the combination of AVE8062 with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in patient...
Primary Objectives: - To determine the excretion balance and systemic exposure of radioactivity after intravenous infusion of [14C]-AVE8062 to humans - To determine the ...
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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 patie...
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The pleura may be affected by primary tumors or metastatic spread of intrathoracic or extrathoracic neoplasms. Primary pleural neoplasms represent ∼10% of all pleural tumors, and malignant lesions a...
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New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.
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Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...
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