A PhaseI/II Study Evaluating the Safety, Tolerability, and Maximally Tolerated Dose of L-377202 Administered Once Every 3 Weeks
This is an open, nonrandomized, rising-dose study in patients with hormone refractory
prostate cancer. Patients will be treated with L-377202 once every three weeks. Plasma
concentrations of L-377202, liberated doxorubicin, and leu-doxorubicin will be obtained at
defined time intervals throughout the study. At least 1 patient will be treated at each
dose level until there is evidence of greater than or equal to Grade 2 drug-related
toxicity. Each patient will be treated at only 1 dose level, although multiple cycles may
be administered until signs of disease progression or unacceptable toxicity are evident.
Doses will be doubled for each subsequent cohort of patients until evidence of greater than
or equal to Grade 2 drug-related toxicity. Upon documentation of greater than or equal to
Grade 2 drug-related toxicity, subsequent dose escalations will proceed along the modified
Fibonacci scale and enroll at least 3 patients per dose level until 1 patient experiences
dose-limiting toxicity (DLT).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of the administration of L-377202 every three weeks in patients with hormone refractory prostate cancer
Every 3 weeks until disease progression or unacceptable toxicity
John Rinehart, M.D.
University of Alabama at Birmingham (no longer employee)
United States: Food and Drug Administration
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|