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Phase I Open-Label, Multicenter, Dose-Escalation Clinical Study of the Safety and Pharmacokinetic Profiles of Weekly Intravenous Administrations of SNS-595 in Patients With Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

Phase I Open-Label, Multicenter, Dose-Escalation Clinical Study of the Safety and Pharmacokinetic Profiles of Weekly Intravenous Administrations of SNS-595 in Patients With Advanced Malignancies


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.


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

- Hemoglobin > or = to 9.0 g/dL

- Absolute Neutrophil Count > or = to 1,500

- Platelets > or = to 100,000

- Calculated or measured creatinine clearance < 50 mL/min

- Serum creatinine < or = 1.5 times the upper limit of normal (ULN)

- AST, ALT, Alkaline Phosphatase < 3 times ULN except if there is hepatic involvement
then AST, ALT, and Alkaline Phosphatase < or = to 5 times ULN

- Total Bilirubin < or = to 2 mg/dL

Exclusion Criteria:

- Prior exposure to SNS-595

- 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 (i.e., 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Daniel C. Adelman, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sunesis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

SPO-0002

NCT ID:

NCT00094159

Start Date:

October 2004

Completion Date:

Related Keywords:

  • Neoplasms
  • Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Stanford University Medical CenterStanford, California  94305-5408
Duke University Medical CenterDurham, North Carolina  27710