A Study Comparing Oral Picoplatin With Intravenous Picoplatin in Subjects With Solid Tumors
Completed · Phase 1
Conditions studied: Bladder Cancer, Breast Cancer, Colorectal Cancer, Gastrointestinal Neoplasm, Head and Neck Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00465725
- Run by
- Poniard Pharmaceuticals
- People needed
- 18
- Starts
- 2007-04-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2009-09-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.)
You may not qualify if…
- 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.)
Where it is running
- Georgia Cancer Specialists — Atlanta, Georgia, United States
- Nevada Cancer Institute — Las Vegas, Nevada, United States
- Northwest Medical Specialties — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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