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Safety Assessment of Weekly Intravenous Infusions of SNS-595 for the Treatment of Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety Assessment of Weekly Intravenous Infusions of SNS-595 for the Treatment of Solid Tumors

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

NCT00094159•Sunesis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether SNS-595 given intravenously weekly for 3 weeks is safe.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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.

Locations (4)

Arizona Cancer Center

Scottsdale, Arizona, United States

Arizona Cancer Center

Tucson, Arizona, United States

Stanford University Medical Center

Stanford, California, United States

Duke University Medical Center

Durham, North Carolina, United States

Key Dates

Start Date

October 1, 2004

Last Updated

May 10, 2007

Conditions

Neoplasms

Interventions

SNS-595

DRUG

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

NCT00026884

Malignant NeoplasmsHereditary Neoplastic Syndromes+3 more

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RECRUITINGPHASE3

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

NCT07213804

Ovarian NeoplasmsFallopian Tube Neoplasms+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 10, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety Assessment of Weekly Intravenous Infusions of SNS-595 for the Treatment of Solid Tumors

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer

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