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
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Breast Cancer
Colorectal Cancer
Gastrointestinal Neoplasm
Head and Neck Cancer
Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Drug: Picoplatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Poniard Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 18
Study Start Date: April 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465725

Locations
United States, Georgia
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30342
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, Washington
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Poniard Pharmaceuticals
Investigators
Study Director: Robert Earhart, MD, PhD Poniard Pharmaceuticals
  More Information

Publications:
Responsible Party: Robert Earhart, MD, PhD Study Director, Poniard Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00465725     History of Changes
Other Study ID Numbers: 0602 Oral Picoplatin
Study First Received: April 23, 2007
Last Updated: September 23, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Poniard Pharmaceuticals:
Picoplatin
tumor
cancer
sarcoma
neoplasm
advanced
platinum
chemotherapy
Solid Tumor

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Breast Neoplasms
Neoplasms
Colorectal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Ovarian Neoplasms
Pancreatic Neoplasms
Prostatic Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Ovarian Diseases

ClinicalTrials.gov processed this record on April 17, 2014