ClinicalTrials Identifier : NCT01831089 .
Updated : 2014_03_31 .
Detailed description :
Clinical trial to determine the maximum tolerated dose (MTD) and the
recommended dose (RD) of PM01183 in combination with weekly paclitaxel, with or without bevacizumab. Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will be explored in a selected cohort of patients to characterize the safety profile and feasibility of this combination, to obtain preliminary information on antitumor activity, to obtain preliminary information on quality of life (QoL), to characterize the pharmacokinetics (PK) of this combination and to detect major drug-drug PK interactions and PK/PD (pharmacokinetic/pharmacodynamic) correlation and to conduct an exploratory pharmacogenomic(PGx) analysis in patients with selected advanced solid tumors.
Condition Breast Cancer
Condition Ovarian Cancer
Condition Gynecological Cancer
Condition Head and Neck Carcinoma
Condition Non-small Cell Lung Cancer
Condition Small Cell Lung Cancer
Condition Non-squamous Cell Lung Cancer
Recruitment Information :_
Status : Recruiting
Start date : 2013-09
Last follow-up date : 2016-06 (Anticipated)
Primary completion date : 2016-06 (Anticipated)
Adminisstration Data :
Organization name : PharmaMar .
Organization study : ID PM1183-A-007-13 .
Sponsor : PharmaMar .
Health Authority : United States: Food and Drug Administration .
Health Authority : Spain: Agencia Española de Medicamentos y Productos Sanitarios .
Health Authority : Switzerland: Swissmedic .
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