Cyclooxygenas were performed during the study

A detailed evaluation of the pharmacokinetics of ASA404 combined CP was carried out in the first six patients Cyclooxygenas in the assessment of the potential drug interaction between ASA404 and paclitaxel and carboplatin combination. To facilitate this, the regime ASA404 ge Was changed, with the first cycle of treatment with PC, then up to five cycles of ASA404 CP, and finally bind the patients still in the study, a single cycle of ASA404 alone. Under the assumption that not more than one dose-limiting toxicity of t unclear to paclitaxel or carboplatin assigned in the first six patients was observed, enrollment continued recruited to about 35 eligible patients in each group of CP and CP ASA404. The treatment was given every 21 days for six cycles or until withdrawal, whichever tt more. In a modification of the patient dose ASA404 or carboplatin, and the interaction between the CP and CP ASA404 arm not allowed.
The dose of paclitaxel was unlocked Changed unless dose reduction was necessary because the toxicity of t Attributable to these funds. Tumors by computer tomography or magnetic resonance imaging assessments. Tumor response was determined by RECIST criteria and as completely’s Full, partial, stable disease or progressive disease. The reaction was best by examining X4 weeks after the first evaluation CONFIRMS. Results of an independent-Dependent committee conducted a blinded radiological examination of all tumor studies. Safety assessments included a symptom Made me a clinical examination before each cycle, 8 and 15 days after administration of the drug and safety monitoring session. Safety assessments of laboratories of H Dermatology and biochemistry were carried out in these moments.
Intensive electrocardiographic assessments were w Performed during the study. Three main types 12 ECGs were obtained 30 minutes before the administration of paclitaxel, and the end of the infusion of carboplatin. Simple ECG were collected immediately before administration of ASA404 then 10, 20, 60 min and 1, 2 and 4 hours from the start of the infusion ASA404. Electrocardiograms were immediately prior to the infusion of paclitaxel and ASA404 infusion and for 1 hour taken from the start of infusion. If a patient has developed a QTc 4520 ms ms or4540, other ECG were recorded until the QTc interval, which within 30 ms on two consecutive ECG. Patients receiving ASA404 vision tests were performed before treatment and follow-up.
That’m Ren best corrected Sehsch Rfe, ophthalmic examination, contrast sensitivity, color contrast sensitivity vision / color and the central visual field. Recruited for the first six patients after early stopping rules were PK Series collected samples before and after administration of carboplatin and paclitaxel in cycle 1 analyzed after ASA404, carboplatin and paclitaxel dosing 2, and 6 after ASA404 monotherapy, three weeks after the end of the cycle . Total and free concentrations of each drug were determined prior to the infusion, at the end of the infusion and at various intervals after the end of infusion. Additionally Tzlich plasma sample for 5 HIAA concentrations of 2 and 4 hours after the start of dosing ASA404 were analyzed on day 1 of cycle 2. All patients participated in a tour p28 screening days before treatment, a study visit every week, and a follow-up of 4 weeks after the end of the study / visit withdrawal.

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