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

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.

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Key information

Conditions

Bladder Cancer Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasm Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Georgia Cancer Specialists, Atlanta, Georgia, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

picoplatin

Drug

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 outcomes

MTD

Time frame: MTD
Comparison of platinum levels excreted in urine from 0-8 and 8-24 hours after start of IV or oral drug

Time frame: PK

Sponsors and collaborators

Lead sponsor

Poniard Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Apr 25, 2007
Registry last updated: Sep 24, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed