A Phase I, Multicenter, Open-label, Dose-Escalation, Safety and Tolerance, and Pharmacokinetic Study of Intravenously Administered CX-3543,on a Daily x 5, Repeated Every 3 Weeks Schedule, in Patients With Advanced Solid Tumors or Lymphomas
CX-4945 is a first-in-class small-molecule targeted cancer therapeutic derived from the
validated fluoroquinolone class of drugs. This drug 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.This Phase 1 study of CX-3543 is designed to test the safety,
tolerability and highest safe dose level of this drug in patients with advanced solid tumor
cancers.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT)
Cycle 1
Yes
United States: Food and Drug Administration
C3-05-001
NCT00955786
July 2005
December 2008
Name | Location |
---|---|
Phoenix, Arizona 85012 | |
Austin, Texas 78705 |