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

NCT00465725 | Completed Phase 1 DMC

• 1 other identifier: 0602 Oral Picoplatin
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• MTD

  MTD

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

  PK

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

Picoplatin DRUG

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age or older.
• ECOG performance status 0-2.
• Life expectancy of at least 12 weeks.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poniard Pharmaceuticals: lead

Study Sites (3)

Georgia Cancer Specialists

Atlanta, Georgia, 30342, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Northwest Medical Specialties

Tacoma, Washington, 98405, United States

Location

Related 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. doi: 10.1038/sj.bjc.6600854.

  PMID: 12671715 BACKGROUND

• 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.

  PMID: 9474239 BACKGROUND

• 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.

  PMID: 9815598 BACKGROUND

Related Links

• Poniard Pharmaceuticals, Inc.

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms; Prostatic Neoplasms; Neoplasms; Sarcoma

Interventions

amminedichloro(2-methylpyridine)platinum(II)

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Digestive System 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; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pancreatic Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Study Officials

• Robert Earhart, MD, PhD

  Poniard Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 25, 2007
• Study Start: April 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 24, 2009

Record last verified: 2009-09

Locations

US (3)