… From April 2006 until September 2008, a total of 236 patients were enrolled in this multicenter
trial. Two hundred and twenty-nine patients were assessable for toxicity, response and …

Purpose: This randomized phase II study was initially designed to test the activity of two dose
schedules of lapatinib (GW572016H), an oral, reversible, dual tyrosine kinase inhibitor of …

… The secondary objectives of the study were to evaluate observed toxicities and progression-free
survival (PFS). The prospective randomized phase III trial was performed under the …

… A randomized phase II design was chosen not to enable comparison of the efficacy of the …
randomized phase III trial. In this way, patients enrolled in the phase II portion of the study …

… The ACT III study (Protocol CDX110-003) was originally an open-label, randomized phase
II/III trial … The phase II portion had a primary endpoint of PFS, and up to 90 patients were to be …

… Given the encouraging response rates observed with the combination of doxorubicin and
paclitaxel (AT), we initiated a randomized phase III trial comparing this regimen to the …

… arm in this study was similar to that observed in our previous randomized phase II trial 11 …
In addition, in an American trial, 10 the addition of CPT-11 to an FU bolus administration (IFL…

… Background: In a randomized phase III trial, sunitinib 50 mg/d on Schedule 4/2 (4 wk on …
Methods: This randomized phase II trial compared sunitinib 50 mg/d on Schedule 4/2 (Arm A) vs. …

… An unexpected observation was the relatively high incidence of brain metastases (17.1%
overall) seen in this trial. A limited number of randomized phase III studies of advanced or …

… A randomized phase II design was chosen not to enable comparison of the efficacy of the …
the EC–DCb efficacy precluded a comparison with EC–D in a formal randomized phase III trial. …