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

Sponsor
Cylene Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT00955292
Collaborator
(none)
12
Enrollment
2
Locations
1
Arm
17.1
Duration (Months)
6
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 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, 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
Study Start Date :
Jul 1, 2007
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Quarfloxin

Drug: Quarfloxin
Escalating doses of quarfloxin administered intravenously for 24 hours once weekly for three weeks every four weeks
Other Names:
  • CX-3543
  • Quarfloxacin

    		•

    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 quarfloxin [One month]

    2. Evaluation of antitumor activity of quarfloxin by objective radiologic assessment [Every 2 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.

    • 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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Cylene Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00955292
    Other Study ID Numbers:
    • C3-07-002
    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