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
  Purpose

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
Lymphoma
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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955786

Locations
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
ClinicalTrials.gov 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
Lymphoma
G-Quadruplex

Additional relevant MeSH terms:
Lymphoma
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014