Phase I Randomized, Placebo-Controlled, Cross-Over, Dose-Finding Pharmacokinetic Study of CoQ10 During One Cycle of Doxorubicin Treatment for Breast Cancer
This is a phase I randomized, placebo-controlled, cross-over pharmacokinetic and
dose-finding study to assess the safety of CoQ10 during doxorubicin treatment for breast
cancer in a maximum of 18 patients. Safety will be assessed by measuring 1) intra-patient
differences in doxorubicin and its active metabolites, with and without CoQ10, and 2)
adverse events. We hypothesize that CoQ10 administration during doxorubicin treatment is
safe and will not affect doxorubicin active metabolites. Using three dose levels of CoQ10,
the maximum tolerated dose (MTD) will be determined by assessing change in doxorubicin
concentration (area under the curve (AUC), change in peak concentration levels (Cmax)), and
adverse events.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
To determine the maximum tolerated dose of CoQ10 that does not alter the pharmacokinetics of doxorubicin
Two weeks prior to cycles 3 and 4 of doxorubicin
Yes
Heather Greenlee, ND, PhD
Principal Investigator
Columbia University
United States: Food and Drug Administration
AAAD8521
NCT00976131
September 2009
September 2013
Name | Location |
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Columbia University Medical Center | New York, New York 10032 |