Dose-escalation Study of CX-3543 in Patients With Advanced Solid Tumors or Lymphomas
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT) [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]
- Recommended Phase 2 dose [ Time Frame: Cycle 1 ] [ Designated as safety issue: Yes ]
- Pharmacokinetics (PK) in humans of intravenously administered CX-3543. [ Time Frame: Monthly ] [ Designated as safety issue: No ]
- Evaluate evidence of antitumor activity of CX-3543 by objective radiographic assessment. [ Time Frame: Every two months ] [ Designated as safety issue: No ]
- Pharmacodynamic evaluation of antitumor activity [ Time Frame: Monthly ] [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Escalating doses of CX-3543 administered intravenously daily for 5 consecutive days every 21 days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955786
|United States, Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Texas|
|San Antonio, Texas, United States, 78229|