Phase1b to Evaluate Safety of AMG706 in Combination With Paclitaxel or Docetaxel for Breast Cancer
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
This open-label, dose-finding, multi-center study is designed to determine the safety and the
maximum tolerated dose of AMG 706 given once daily in combination with either weekly
paclitaxel (Arm A) or once-every-3 week docetaxel (Arm B) in subjects with locally recurrent
or metastatic breast cancer. Secondarily, this study will evaluate the pharmacokinetic (PK)
profile of AMG 706 in both treatment arms, the PK profile of paclitaxel in Arm A and the PK
profile of docetaxel in Arm B. Additionally, this study will assess objective tumor response
and duration of response. Exploratory endpoints include the investigation of potential
biomarker development and to assess the effects of genetic variation in drug metabolism
genes, cancer genes and drug target genes on subject response to AMG 706 in combination with
paclitaxel or docetaxel.