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

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cylene Pharmaceuticals

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.