A Study Comparing Oral Picoplatin With Intravenous Picoplatin in Subjects With Solid Tumors

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poniard Pharmaceuticals

Criteria

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.)