A Phase 1/2, Open-Label Study Of Bosutinib Administered In Combination With Capecitabine In Subjects With Solid Tumor And ErbB2 Negative Locally Advanced Or Metastatic Breast Cancer
The study was prematurely discontinued following Part 1 evaluation, when the sponsor
concluded that further translational biomarker analyses were needed to better define the
breast tumor biomarkers that predict sensitivity to Src family kinase inhibitors. Thus the
Sponsor made a determination to stop the study after Part 1 as communicated to investigators
on 02Dec2010 . No subjects were enrolled into Part 2 of this study. The study was not
terminated due to safety reasons.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) - Part 1
The MTD contour is defined as the dose combinations that achieve a toxicity rate (dose-limiting toxicity [DLT] rate) of less than (<) 1/3. The observed toxicity rates for all the reporting groups (to which at least 1 cohort of participants was allocated) was estimated by calculating the proportion of DLTs observed in the first 21 days of treatment at those reporting groups. DLT includes grade (Gr) 3/4 nausea, vomiting, diarrhea, or asthenia more than 3 days, Gr 4 hematologic toxicities, delayed study treatment administration due to dose toxicities by more than 3 weeks. Pre-defined criterion for MTD: if a higher dose level of capecitabine existed such that the same dose level of bosutinib had a DLT rate of <1/3, no MTD was recommended for that capecitabine dose and if even the lowest dose of bosutinib achieved a toxicity rate of greater than (>) 1/3, no MTD was recommended for that capecitabine dose level.
Part 1 Baseline up to Day 21
Pfizer CT.gov Call Center
United States: Food and Drug Administration
|Pfizer Investigational Site||Detroit, Michigan 48201|
|Pfizer Investigational Site||North Adams, Massachusetts 01247|