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

NCT ID: NCT00955292

Last Updated: 2009-08-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2008-12-31

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.

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.

Conditions

Advanced Solid Tumors; Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Quarfloxin

Group Type: EXPERIMENTAL

Quarfloxin

Intervention Type: DRUG

Escalating doses of quarfloxin administered intravenously for 24 hours once weekly for three weeks every four weeks

Interventions

Quarfloxin

Escalating doses of quarfloxin administered intravenously for 24 hours once weekly for three weeks every four weeks

Intervention Type: DRUG

Other Intervention Names

CX-3543; Quarfloxacin

Eligibility 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cylene Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Cylene Pharmaceuticals

Locations

Scottsdale, Arizona, United States

San Antonio, Texas, United States

Countries

United States

Other Identifiers

C3-07-002

Identifier Type: -

Identifier Source: org_study_id