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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00465725
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : September 24, 2009
Information provided by:
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.

Condition or disease Intervention/treatment 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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : April 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. MTD [ Time Frame: MTD ]
  2. Comparison of platinum levels excreted in urine from 0-8 and 8-24 hours after start of IV or oral drug [ Time Frame: PK ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00465725

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
Study Director: Robert Earhart, MD, PhD Poniard Pharmaceuticals

Additional Information:
Responsible Party: Robert Earhart, MD, PhD Study Director, Poniard Pharmaceuticals Identifier: NCT00465725     History of Changes
Other Study ID Numbers: 0602 Oral Picoplatin
First Posted: April 25, 2007    Key Record Dates
Last Update Posted: September 24, 2009
Last Verified: September 2009

Keywords provided by Poniard Pharmaceuticals:
Solid Tumor

Additional relevant MeSH terms:
Colorectal Neoplasms
Pancreatic Neoplasms
Head and Neck Neoplasms
Urinary Bladder Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Intestinal Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases