A Study Comparing Oral Picoplatin With Intravenous Picoplatin in Subjects With Solid Tumors
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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 |
|---|---|---|
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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 |
- 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 |
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| 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 | |
| Study Director: | Robert Earhart, MD, PhD | Poniard Pharmaceuticals |
More Information
Additional 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 May 16, 2013