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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Breast Cancer, Colorectal Cancer, Gastrointestinal Neoplasm, Head and Neck Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer

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Trial Information

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


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.


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.)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD

Outcome Time Frame:

MTD

Safety Issue:

Yes

Principal Investigator

Robert Earhart, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Poniard Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

0602 Oral Picoplatin

NCT ID:

NCT00465725

Start Date:

April 2007

Completion Date:

July 2009

Related Keywords:

  • Bladder Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Gastrointestinal Neoplasm
  • Head and Neck Cancer
  • Lung Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Prostate Cancer
  • Picoplatin
  • tumor
  • cancer
  • sarcoma
  • neoplasm
  • advanced
  • platinum
  • chemotherapy
  • Solid Tumor
  • 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

Name

Location

Georgia Cancer SpecialistsDecatur, Georgia  30033
Northwest Medical SpecialtiesTacoma, Washington  98405
Nevada Cancer InstituteLas Vegas, Nevada  89135