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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00955292
Recruitment Status : Terminated (Modified dose schedule presented no advantage over previously studied schedule)
First Posted : August 10, 2009
Last Update Posted : August 10, 2009
Information provided by:
Cylene Pharmaceuticals

August 7, 2009
August 10, 2009
August 10, 2009
July 2007
April 2008   (Final data collection date for primary outcome measure)
  • Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT) [ Time Frame: Cycle 1 ]
  • Recommended Phase 2 dose [ Time Frame: Cycle 1 ]
Same as current
No Changes Posted
  • Pharmacokinetics (PK) in humans of intravenously administered quarfloxin [ Time Frame: One month ]
  • Evaluation of antitumor activity of quarfloxin by objective radiologic assessment [ Time Frame: Every 2 months ]
  • Pharmacodynamic evaluation of antitumor activity [ Time Frame: Monthly ]
Same as current
Not Provided
Not Provided
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
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.
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.
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Advanced Solid Tumors
  • Lymphoma
Drug: Quarfloxin
Escalating doses of quarfloxin administered intravenously for 24 hours once weekly for three weeks every four weeks
Other Names:
  • CX-3543
  • Quarfloxacin
Experimental: Quarfloxin
Intervention: Drug: Quarfloxin
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2008
April 2008   (Final data collection date for primary outcome measure)

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.
  • Normal oxygen saturation by pulse oximetry on room air
  • A negative pregnancy test (if female).
  • Acceptable liver function as evaluated by laboratory results
  • Acceptable renal 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 requiring 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 an uncorrectable pulmonary compromise.
  • 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 one month 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 agent.
  • Patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones, biological agent or formulation.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
C. Padgett, Cylene Pharmaceuticals
Cylene Pharmaceuticals
Not Provided
Not Provided
Cylene Pharmaceuticals
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP