Dose-escalation Study of CX-3543 in Patients With Advanced Solid Tumors or Lymphomas
NCT ID: NCT00955786
Last Updated: 2009-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2005-07-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CX-3543
CX-3543
Escalating doses of CX-3543 administered intravenously daily for 5 consecutive days every 21 days.
Interventions
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CX-3543
Escalating doses of CX-3543 administered intravenously daily for 5 consecutive days every 21 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Cylene Pharmaceuticals
INDUSTRY
Responsible Party
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Cylene Pharmaceuticals
Locations
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Scottsdale, Arizona, United States
San Antonio, Texas, United States
Countries
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Other Identifiers
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C3-05-001
Identifier Type: -
Identifier Source: org_study_id
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