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

Phase 1

Completed

• Conditions: Bladder Cancer; Breast Cancer; Colorectal Cancer; Gastrointestinal Neoplasm; Head and Neck Cancer; Lung Cancer; Ovarian Cancer; Pancreatic Cancer; Prostate Cancer
• Interventions: Drug: Picoplatin

• Registration Number: NCT00465725
• Lead Sponsor: Poniard Pharmaceuticals

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 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.

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 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 Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-23
• Study First Submitted QC: 2007-04-23
• Study First Posted: 2007-04-25
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-23
• Last Update Posted: 2009-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Picoplatin	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.

Primary Outcome Measures

Name	Time	Method
MTD	MTD
Comparison of platinum levels excreted in urine from 0-8 and 8-24 hours after start of IV or oral drug	PK

Trial Locations

Locations (3)

Northwest Medical Specialties; 🇺🇸 Tacoma, Washington, United States

Nevada Cancer Institute; 🇺🇸 Las Vegas, Nevada, United States

Georgia Cancer Specialists; 🇺🇸 Atlanta, Georgia, United States