NCT00068172

Study of PI-88 in Patients With Advanced Melanoma

A Phase I/II Study of PI-88 in Advanced Malignancies (Phase I), and in Advanced Melanoma (Phase II)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 88 (planned)
• Sponsor: Cellxpert Biotechnology Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether PI-88 is safe and effective in the treatment of advanced melanoma.

Detailed description

PI-88 is an investigational drug that works by a novel mechanism which may reduce the rate of growth of tumors, and also the spread of cancer cells around the body. It also has an effect upon blood clotting. The purpose of this study is to assess if PI-88 has any benefit to patients with advanced melanoma, as well as to gain further information on the safety of the drug. All patients in the study will receive the study drug at the same dose level. The dose of PI-88 that will be given is based on the dose that was found to be the best in the phase I portion of this study. The drug will be injected subcutaneously (under the skin) once daily for 4 days every week. Patients will be treated with PI-88 for up to 6 months, but if the drug is well tolerated and effective, patients may be offered further treatment with the drug.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	PI-88

Timeline

• Start date: 2001-07-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2003-09-10
• Last updated: 2022-06-27

Locations

1 site across 1 country: United States