NCT Number: NCT00091585
Initial Safety Assessment of SNS-595 for the Treatment of Solid Tumors.
The purpose of this study is to determine whether SNS-595 given intravenously once every 3 weeks is safe.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Arizona Cancer Center, Scottsdale, Arizona, United States
About this study
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood) and determining the dose and dose schedule for the next phase of studies with SNS-595.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Must give written informed consent
- 18 years of age
- Advanced solid malignant tumors
- Tumor can be measured and evaluated
- Blood tests are within standard limits
- Normal blood coagulation
- ECOG Performance Status equal to 0 or 1
Exclusion criteria
- Pregnant or breastfeeding.
- Women of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
- Heart attack, stroke/TIA or other blood clotting event (deep vein thrombosis or pulmonary embolus) within 6 months before the screen visit.
- Requires kidney dialysis (hemodialysis or peritoneal).
- Known bleeding disorder (ie, hemophilia, von Willebrand Disease, coagulopathy, etc.).
- Received an investigational agent or prior chemotherapy or immunotherapy within 28 days before first dose of SNS-595
- Receiving therapeutic anticoagulation therapy (coumadin, heparin, etc.).
- Currently receiving corticosteroids (inhaled steroids for breathing diseases are allowed) or seizure medications.
- Any medical, psychological, or social condition that, in the opinion of the Principal Investigator, would contraindicate the patient's participation in the clinical trial due to safety and or compliance with study procedures.
Treatment and study plan
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Lead sponsor
Sunesis Pharmaceuticals
Industry
Registry information
Official study title
Phase I Open-Label, Multicenter, Dose-Escalation Clinical Study of the Initial Safety and Pharmacokinetic Profiles of Intravenous Administration of SNS-595 in Patients With Advanced Malignancies
Important dates
- Study start
- 2004
- Study completion
- 2006
- First posted
- Sep 14, 2004
- Registry last updated
- May 10, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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