Dose-escalation Study of CX-3543 in Patients With Advanced Solid Tumors or Lymphomas

This study has been completed.
Information provided by:
Cylene Pharmaceuticals Identifier:
First received: August 6, 2009
Last updated: August 7, 2009
Last verified: August 2009

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.

Condition Intervention Phase
Advanced Solid Tumors
Drug: CX-3543
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Cylene Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: July 2005
Study Completion Date: December 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CX-3543 Drug: CX-3543
Escalating doses of CX-3543 administered intravenously daily for 5 consecutive days every 21 days.
Other Names:
  • quarfloxacin
  • quarfloxin

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with histologically confirmed solid tumors or lymphomas.
  • Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy.
  • One or more tumors measurable on radiograph or CT scan, or evaluable disease. (e.g., malignant ascites)
  • Karnofsky performance status of greater than or equal to 70.
  • Life expectancy of at least 3 months.
  • Age at least 18 years.
  • Patients must have central IV access, or agree to the insertion of a central IV line.
  • A negative urine pregnancy test (if female.)
  • Acceptable liver function as evaluated by laboratory results
  • Acceptable hematologic status as evaluated by laboratory results
  • No clinically significant urinalysis abnormalities
  • Acceptable coagulation status as evaluated by laboratory results
  • Fertile men and women must use effective contraceptive methods during the study.

Exclusion Criteria:

  • Seizure disorders not controlled by anticonvulsant therapy.
  • Known brain metastases (unless previously treated and well controlled for a period of greater than or equal to 3 months.)
  • Severe chronic obstructive pulmonary disease with hypoxemia or a pulmonary compromise not correctable with therapy.
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to the first dose of test drug.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
  • Pregnant or nursing women.
  • Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or Mitomycin C.)
  • Unwillingness or inability to comply with procedures required in this protocol.
  • Known infection with HIV, hepatitis B, or hepatitis C.
  • Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
  • Patients who are currently receiving any other investigational therapy.
  • Patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones), biological agent, or formulation.
  Contacts and Locations
Please refer to this study by its identifier: NCT00955786

United States, Arizona
Scottsdale, Arizona, United States, 85259
United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Cylene Pharmaceuticals
  More Information

No publications provided

Responsible Party: C. Padgett, Cylene Pharmaceuticals Identifier: NCT00955786     History of Changes
Other Study ID Numbers: C3-05-001
Study First Received: August 6, 2009
Last Updated: August 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Cylene Pharmaceuticals:
Solid Tumors

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on April 17, 2014