A Randomized Crossover Oral Bioavailability Study Comparing the Pharmacokinetics and Pharmacodynamics of Picoplatin Administered Orally With Picoplatin Administered Intravenously in Subjects With Advanced Non-Hematological Malignancies
The primary study design is a randomized, two-period crossover, open label study in which a
single dose (Cycle 1) of picoplatin will be given either IV or by oral capsule, followed 4
weeks later by a single dose (Cycle 2) of picoplatin given either IV or by oral capsule
(whichever route was not used in Cycle 1). Participants may continue to receive cycles of IV
picoplatin every 3 weeks, beginning with Cycle 3, as part of a Continuation Study.
This study will determine the relative safety, bioavailability, pharmacokinetics,
pharmacodynamics, and urinary excretion of picoplatin administered orally with reference to
picoplatin administered intravenously.
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Robert Earhart, MD, PhD
United States: Food and Drug Administration
0602 Oral Picoplatin
|Georgia Cancer Specialists||Decatur, Georgia 30033|
|Northwest Medical Specialties||Tacoma, Washington 98405|
|Nevada Cancer Institute||Las Vegas, Nevada 89135|