NCT00090727

Chemotherapy for Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

A Phase 1, Open-Label, Dose-Escalation Study of AQ4N Administered Intravenously in Patients With Advanced Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (planned)
• Sponsor: Novacea · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purposes of this study are to determine: * the largest dose of AQ4N that can be safely given once a week for three weeks out of a 4 week cycle * the side effects of AQ4N when given on the above schedule * how much AQ4N is in the blood and urine at specific times after administration and how the body get rids of AQ4N * if AQ4N helps treat cancer

Detailed description

This study is for people who have advanced cancer for which standard chemotherapy did not work or for which there are no reliably, effective treatments. AQ4N is an experimental chemotherapy that is thought to target tumor areas with low oxygen content and low blood supply; tumor areas that are usually the most resistant to standard chemotherapy and radiation treatment. AQ4N may be beneficial in cancer treatment by interfering with a protein that is required for cells to grow and divide, causing tumors to die or to delay their growth. All patients in this study will receive AQ4N. The dose will be increased for each new patient or group of patients until the maximum tolerated dose is reached.

Conditions

• Solid Malignancies
• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	AQ4N

Timeline

• Start date: 2004-08-01
• First posted: 2004-09-06
• Last updated: 2006-11-02

Locations

2 sites across 1 country: United States