Status:
COMPLETED
A Study Comparing Oral Picoplatin With Intravenous Picoplatin in Subjects With Solid Tumors
Lead Sponsor:
Poniard Pharmaceuticals
Conditions:
Bladder Cancer
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 re...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00465725
Start Date
April 1 2007
End Date
July 1 2009
Last Update
September 24 2009
Active Locations (3)
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1
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30342
2
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
3
Northwest Medical Specialties
Tacoma, Washington, United States, 98405