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

This study has been completed.
Sponsor:
Information provided by:
Cylene Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00955786
First received: August 6, 2009
Last updated: August 7, 2009
Last verified: August 2009

August 6, 2009
August 7, 2009
July 2005
July 2007   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00955786 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Dose-escalation Study of CX-3543 in Patients With Advanced Solid Tumors or Lymphomas
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

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.

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
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Solid Tumors
  • Lymphoma
Drug: CX-3543
Escalating doses of CX-3543 administered intravenously daily for 5 consecutive days every 21 days.
Other Names:
  • quarfloxacin
  • quarfloxin
Experimental: CX-3543
Intervention: Drug: CX-3543
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 2008
July 2007   (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.
  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00955786
C3-05-001
No
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