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

Poniard Pharmaceuticals

Status and phase: Completed; Phase 1

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

Treatments: Drug: Picoplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00465725

0602 Oral Picoplatin

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Drug: Picoplatin