27
Participants
Start Date
July 27, 2006
Primary Completion Date
March 24, 2009
Study Completion Date
January 6, 2012
AEG35156
After a recommended phase II dose (RPTD) of AEG35156 has been determined with docetaxel 75 mg/m2, patients will be accrued to the RPTD-1 plus docetaxel 100 mg/m2, and possibly RPTD plus docetaxel 100 mg/m2, to determine the RPTD of AEG35156 in combination with docetaxel 100 mg/m2 given every three weeks.
docetaxel
After a recommended phase II dose (RPTD) of AEG35156 has been determined with docetaxel 75 mg/m2, patients will be accrued to the RPTD-1 plus docetaxel 100 mg/m2, and possibly RPTD plus docetaxel 100 mg/m2, to determine the RPTD of AEG35156 in combination with docetaxel 100 mg/m2 given every three weeks.
protein expression analysis
Cycle 1: Pre-dose on Days -2, 1, 8 and 15; repeat every 2-4 days if LFTs \> 5 x ULN1 Cycle 2: Prior to each infusion; repeat every 2-4 days if LFTs \> 5 x ULN1
reverse transcriptase-polymerase chain reaction
Data will be summarized by descriptive statistics relevant to each of the proposed pharmacodynamic studies.
flow cytometry
Data will be summarized by descriptive statistics relevant to each of the proposed pharmacodynamic studies.
immunoenzyme technique
Data will be summarized by descriptive statistics relevant to each of the proposed pharmacodynamic studies.
immunohistochemistry staining method
The plasma concentration/ time data will be analysed using non-compartmental methods. The pharmacokinetic parameters to be determined for AEG35156 include the maximum observed plasma concentration (Cmax), the half-life (T1/2), and mean residence time (MRT).
laboratory biomarker analysis
The plasma concentration/ time data will be analysed using non-compartmental methods. The pharmacokinetic parameters to be determined for AEG35156 include the maximum observed plasma concentration (Cmax), the half-life (T1/2), and mean residence time (MRT).
BCCA - Vancouver Cancer Centre, Vancouver
Univ. Health Network-Princess Margaret Hospital, Toronto
McGill University - Dept. Oncology, Montreal
Lead Sponsor
NCIC Clinical Trials Group
NETWORK