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

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumors, Lymphoma

In brief

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.

Key facts

Study ID

NCT00955292

Run by

Cylene Pharmaceuticals

People needed

12

Starts

2007-07-01

Expected to finish

2008-12-01

Last updated by the study team

2009-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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