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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465725
• Other study ID #: 0602 Oral Picoplatin
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2007
• Last updated: September 23, 2009
• Start date: April 2007
• Est. completion date: July 2009

Study information

• Verified date: September 2009
• Source: Poniard Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Colorectal Cancer
• Digestive System Neoplasms
• Gastrointestinal Neoplasm
• Gastrointestinal Neoplasms
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Prostate Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Georgia Cancer Specialists	Atlanta	Georgia
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	Northwest Medical Specialties	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Poniard Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (3)

Beale P, Judson I, O'Donnell A, Trigo J, Rees C, Raynaud F, Turner A, Simmons L, Etterley L. A Phase I clinical and pharmacological study of cis-diamminedichloro(2-methylpyridine) platinum II (AMD473). Br J Cancer. 2003 Apr 7;88(7):1128-34. — View Citation

Holford J, Raynaud F, Murrer BA, Grimaldi K, Hartley JA, Abrams M, Kelland LR. Chemical, biochemical and pharmacological activity of the novel sterically hindered platinum co-ordination complex, cis-[amminedichloro(2-methylpyridine)] platinum(II) (AMD473). Anticancer Drug Des. 1998 Jan;13(1):1-18. — View Citation

Raynaud FI, Boxall FE, Goddard PM, Valenti M, Jones M, Murrer BA, Abrams M, Kelland LR. cis-Amminedichloro(2-methylpyridine) platinum(II) (AMD473), a novel sterically hindered platinum complex: in vivo activity, toxicology, and pharmacokinetics in mice. Clin Cancer Res. 1997 Nov;3(11):2063-74. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD		MTD	Yes
Primary	Comparison of platinum levels excreted in urine from 0-8 and 8-24 hours after start of IV or oral drug		PK	Yes