A Study Comparing Oral Picoplatin With Intravenous Picoplatin in Subjects With Solid Tumors
Picoplatin is a new platinum-based chemotherapy drug that has been studied in a variety of cancers. Phase 1 and 2 studies have demonstrated that picoplatin may be effective in patients whose cancer returns or does not improve after treatment with chemotherapy. In these studies, picoplatin was administered intravenously. A capsule containing picoplatin has been formulated. This study will investigate the activity of the oral capsule in humans. Participants with advanced solid tumors will be enrolled.
Head and Neck Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- MTD [ Time Frame: MTD ] [ Designated as safety issue: Yes ]
- Comparison of platinum levels excreted in urine from 0-8 and 8-24 hours after start of IV or oral drug [ Time Frame: PK ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
two-period crossover, open label study in which a single dose (Cycle 1) of picoplatin will be given either IV or PO, followed 4 weeks later by a single dose (Cycle 2) of picoplatin given by the route not used for Cycle 1. Subjects subsequently may continue to receive IV picoplatin commencing with Cycle 3 in a Continuation Study.
The IV dose will be 120 mg/m2. Three oral dose levels will be studied sequentially (6 subjects per dose level) in the absence of dose limiting toxicity 200 mg, 300 mg, or 400 mg total dose.
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.
|United States, Georgia|
|Georgia Cancer Specialists|
|Atlanta, Georgia, United States, 30342|
|United States, Nevada|
|Nevada Cancer Institute|
|Las Vegas, Nevada, United States, 89135|
|United States, Washington|
|Northwest Medical Specialties|
|Tacoma, Washington, United States, 98405|
|Study Director:||Robert Earhart, MD, PhD||Poniard Pharmaceuticals|