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
18 Years
N/A
Both
Bladder Cancer, Breast Cancer, Colorectal Cancer, Gastrointestinal Neoplasm, Head and Neck Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer
Trial Information
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.
Inclusion Criteria:
- Histological diagnosis of non-hematological malignancy.
- Patients for whom no standard therapy exists and for whom, in the opinion of the
investigator, treatments with single agent picoplatin is appropriate.
- 18 years of age or older.
- ECOG performance status 0-2.
- Life expectancy of at least 12 weeks.
(Additional inclusion criteria apply.)
Exclusion Criteria:
- Symptomatic or uncontrolled brain metastases.
- Prior radiation involving ≥ 30% of the total bone marrow space.
- Any concurrent severe and/or uncontrolled medical conditions which could compromise
participation in the study.
- Gastrointestinal surgery that might interfere with absorption of orally administered
drug.
- Active inflammatory bowel disease, gastritis, ulcers, gastrointestinal or rectal
bleeding.
- Clinical evidence of pancreatic injury or active pancreatitis.
- Female subjects who are pregnant or breastfeeding.
(Additional exclusion criteria apply.)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
MTD
Outcome Time Frame:
MTD
Safety Issue:
Yes
Principal Investigator
Robert Earhart, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Poniard Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
0602 Oral Picoplatin
NCT ID:
NCT00465725
Start Date:
April 2007
Completion Date:
July 2009
Related Keywords:
- Bladder Cancer
- Breast Cancer
- Colorectal Cancer
- Gastrointestinal Neoplasm
- Head and Neck Cancer
- Lung Cancer
- Ovarian Cancer
- Pancreatic Cancer
- Prostate Cancer
- Picoplatin
- tumor
- cancer
- sarcoma
- neoplasm
- advanced
- platinum
- chemotherapy
- Solid Tumor
- Urinary Bladder Neoplasms
- Breast Neoplasms
- Neoplasms
- Colorectal Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Head and Neck Neoplasms
- Lung Neoplasms
- Ovarian Neoplasms
- Pancreatic Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|---|
| Georgia Cancer Specialists | Decatur, Georgia 30033 |
| Northwest Medical Specialties | Tacoma, Washington 98405 |
| Nevada Cancer Institute | Las Vegas, Nevada 89135 |
