A Study Comparing Oral Picoplatin With Intravenous Picoplatin in Subjects With Solid Tumors
|ClinicalTrials.gov Identifier: NCT00465725|
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : September 24, 2009
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Breast Cancer Colorectal Cancer Gastrointestinal Neoplasm Head and Neck Cancer Lung Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer||Drug: Picoplatin||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
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.
- MTD [ Time Frame: MTD ]
- Comparison of platinum levels excreted in urine from 0-8 and 8-24 hours after start of IV or oral drug [ Time Frame: PK ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465725
|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|