Etoposide and baseline characteristics for the 35 enrolled and treated patients

chemotherapy in the safety lead in phase, patients were to receive maintenance therapy BMS-354825 with enzastaurin 125 mg PO BID or enzastaurin 250 mg PO BID . If no unexpected safety signals were observed in cycle 1 of cohort 2, a multicenter, randomized, double blind, placebo controlled, phase II study was to be initiated in patients with nonsquamous NSCLC. Patients were to be randomized 1: 1 and receive cisplatin pemetrexed combined with either enzastaurin or placebo . The planned dosing schedule for arm A was to be the same as in cohort 2 of the lead in phase. After completing chemotherapy in phase II, patients were to receive maintenance therapy of 250 mg PO BID enzastaurin or placebo .
The combination Etoposide clinical trial of chemotherapy plus either enzastaurin or placebo was continued for 6 cycles if the patient had a complete response or partial response, and for 4 cycles if the patient had stable disease. Patients continued treatment with study therapy until progressive disease or unacceptable toxicity occurred. Safety was assessed before each cycle using the Common Terminology Criteria for Adverse Events, version 3.0. All drug related AEs were classified as ‘possibly’related. The protocol was approved by the ethical Etoposide structure review boards of the institutions, and patients provided written informed consent. A total of 22 patients were enrolled in phase II. One of these patients was not randomized to either treatment arm but received cisplatin pemetrexed and was included in the safety analysis. Demographic and baseline characteristics for the 35 enrolled and treated patients are summarized in table 1 .
Safety Initially, 5 patients in cohort 1 completed cycle 1; 1 additional patient discontinued the study during cycle 1 due to a serious AE . Of the 5 patients who were initially enrolled and completed cycle 1, 1 Etoposide solubility patient had drug related grade 3 arthralgia and myalgia. Three patients experienced drug related serious AEs . One of these AEs was considered a major clinical finding that led to further expansion of cohort 1. Three additional patients were enrolled and completed cycle 1, with no toxicities grade 1 1 reported. Cohort 2 was then initiated with 4 patients, none of whom had serious AEs or toxicities grade 1 1 in cycle 1. Since the toxicity profile of the combination was acceptable in the 12 evaluable patients, the dose of cohort 2 was chosen for the subsequent randomized phase.
In the phase II study, 2 patients in arm B experienced drug related serious AEs: duodenal ulcer and candidiasis and tachyarrhythmia . One patient in arm A discontinued the study due to drug related hypertension and 3 patients required transfusions . Grade 3/4 AEs for the welfare state safety lead in phase and phase II are summarized in table 2 . Efficacy Of the 8 evaluable patients in cohort 1 of the safety lead in phase, 4 patients had partial response , 2 patients had stable disease and 2 patients had progressive disease. One patient was not assessed after baseline . In cohort 2, all 4 patients had partial response , for a total of 7 of 13 treated patients with confirmed partial responses in the safety lead in phase. After interim analyses of two other randomized studies on NSCLC that showed no additional benefit for patients treated with a combination of enzastaurin and chemotherapy.

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