Breast Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility 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.)

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT00465725

Recruitment Status:

Completed

Sponsor:

Poniard Pharmaceuticals

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 3 Locations for this study

See Locations Near You

Georgia Cancer Specialists
Atlanta Georgia, 30342, United States
Nevada Cancer Institute
Las Vegas Nevada, 89135, United States
Northwest Medical Specialties
Tacoma Washington, 98405, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

18

Study ID:

NCT00465725

Recruitment Status:

Completed

Sponsor:


Poniard Pharmaceuticals

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider