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

P

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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