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

This study has been completed.
Sponsor:
Information provided by:
Poniard Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00465725
First received: April 23, 2007
Last updated: September 23, 2009
Last verified: September 2009

April 23, 2007
September 23, 2009
April 2007
July 2009   (final data collection date for primary outcome measure)
  • MTD [ Time Frame: MTD ] [ Designated as safety issue: Yes ]
  • Comparison of platinum levels excreted in urine from 0-8 and 8-24 hours after start of IV or oral drug [ Time Frame: PK ] [ Designated as safety issue: Yes ]
  • Comparison of platinum levels excreted in urine from 0-8 and 8-24 hours after start of IV or oral drug.
  • Comparison of platinum levels in plasma and plasma ultrafiltrate between IV and oral administration
Complete list of historical versions of study NCT00465725 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study Comparing Oral Picoplatin With Intravenous Picoplatin in Subjects With Solid Tumors
A Randomized Crossover Oral Bioavailability Study Comparing the Pharmacokinetics and Pharmacodynamics of Picoplatin Administered Orally With Picoplatin Administered Intravenously in Subjects With Advanced Non-Hematological Malignancies

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bladder Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Gastrointestinal Neoplasm
  • Head and Neck Cancer
  • Lung Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Prostate Cancer
Drug: Picoplatin
The IV dose will be 120 mg/m2. Three oral dose levels will be studied sequentially (6 subjects per dose level) in the absence of dose limiting toxicity 200 mg, 300 mg, or 400 mg total dose.
Experimental: 1
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.
Intervention: Drug: Picoplatin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
July 2009
July 2009   (final data collection date for primary outcome measure)

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.)

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00465725
0602 Oral Picoplatin
Yes
Robert Earhart, MD, PhD Study Director, Poniard Pharmaceuticals
Poniard Pharmaceuticals
Not Provided
Study Director: Robert Earhart, MD, PhD Poniard Pharmaceuticals
Poniard Pharmaceuticals
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP