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

Completed · Phase 1

Conditions studied: Advanced Solid Tumors, Lymphoma

In brief

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.

Key facts

Study ID

NCT00955786

Run by

Cylene Pharmaceuticals

People needed

48

Starts

2005-07-01

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.
• 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.

You may not qualify if…

• 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.

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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