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

Primary Purpose

Bladder Cancer, Breast Cancer, Colorectal Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Picoplatin

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Picoplatin, tumor, cancer, sarcoma, neoplasm, advanced, platinum, chemotherapy, Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

Georgia Cancer Specialists
Nevada Cancer Institute
Northwest Medical Specialties

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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.

Outcomes

Primary Outcome Measures

MTD

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00465725

First Posted

April 23, 2007

Last Updated

September 23, 2009

Sponsor

Poniard Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00465725

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Poniard Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer, Breast Cancer, Colorectal Cancer, Gastrointestinal Neoplasm, Head and Neck Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer

Keywords

Picoplatin, tumor, cancer, sarcoma, neoplasm, advanced, platinum, chemotherapy, Solid Tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Picoplatin

Intervention Description

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 Outcome Measure Information:

Title

MTD

Time Frame

MTD

Title

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

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Earhart, MD, PhD

Organizational Affiliation

Poniard Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Georgia Cancer Specialists

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Nevada Cancer Institute

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89135

Country

United States

Facility Name

Northwest Medical Specialties

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12671715

Citation

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. doi: 10.1038/sj.bjc.6600854.

Results Reference

background

PubMed Identifier

9474239

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.

Results Reference

background

PubMed Identifier

9815598

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.

Results Reference

background

Links:

URL

http://www.poniard.com

Description

Poniard Pharmaceuticals, Inc.

Learn more about this trial

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

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