NCT00955292

Dose-escalation Study of Quarfloxin in Patients With Advanced Solid Tumors or Lymphomas

A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Quarfloxin Administered Intravenously Weekly for Three Weeks of a Four Week Cycle in Patients With Advanced Solid Tumors or Lymphomas

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Cylene Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 1 study of quarfloxin (CX-3543) is designed to test the safety, tolerability, and highest safe dose of this drug when administered intravenously weekly for three weeks of a four week cycle in patients with advanced solid tumors.

Detailed description

Quarfloxin is a first-in-class small-molecule targeted cancer therapeutic derived from the validated fluoroquinolone class of drugs. Quarfloxin was rationally designed to target a G-quadruplex (QPLX) DNA structure and disrupt protein-DNA interactions essential to cancer cells. The QPLX targeted by quarfloxin forms within ribosomal DNA (rDNA) and the QPLX is bound by the nucleolin protein.

Conditions

• Advanced Solid Tumors
• Lymphoma

Interventions

Type	Name	Description
DRUG	Quarfloxin	Escalating doses of quarfloxin administered intravenously for 24 hours once weekly for three weeks every four weeks

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-04-01
• Completion: 2008-12-01
• First posted: 2009-08-10
• Last updated: 2009-08-10

Locations

2 sites across 1 country: United States