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

Sponsor
Cylene Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00955786
Collaborator
(none)
48
Enrollment
2
Locations
1
Arm
41
Duration (Months)
24
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Jul 1, 2005
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT) [Cycle 1]

    2. Recommended Phase 2 dose [Cycle 1]

    Secondary Outcome Measures

    1. Pharmacokinetics (PK) in humans of intravenously administered CX-3543. [Monthly]

    2. Evaluate evidence of antitumor activity of CX-3543 by objective radiographic assessment. [Every two months]

    3. Pharmacodynamic evaluation of antitumor activity [Monthly]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Scottsdale Arizona United States 85259
    2 San Antonio Texas United States 78229

    Sponsors and Collaborators

    • Cylene Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00955786
    Other Study ID Numbers:
    • C3-05-001
    First Posted:
    Aug 10, 2009
    Last Update Posted:
    Aug 10, 2009
    Last Verified:
    Aug 1, 2009
    Keywords provided by , ,
    Solid Tumors
    Lymphoma
    G-Quadruplex
    Additional relevant MeSH terms:
    Lymphoma

    Study Results

    No Results Posted as of Aug 10, 2009