Safety and Tolerability Study of SNS-314 for Advanced Solid Tumors

Sunesis Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: SNS-314

Study type: Interventional

Funder types: Industry

Identifiers

NCT00519662

SPO-0011

Details and patient eligibility

About

This is a study to assess the safety and tolerability of SNS-314 in advanced solid tumors in humans.

Full description

Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood).

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced solid tumor and that is measurable by a scan

Exclusion criteria

• Uncontrolled or untreated central nervous system metastases
• Cerebrovascular accident/transient ischemic attack up to 6 months before Cycle 1 Day 1
• Any of the following cardiac conditions:
• History of myocardial infarction, acute coronary syndromes up to 12 weeks before Cycle 1 Day 1
• Class III or IV heart failure up to 6 months before Cycle 1 Day 1
• Baseline heart rate corrected QT interval (QTc)> 450 msec
• History of ventricular arrhythmias up to 6 months before Cycle 1 Day 1
• Use of medications that prolong the QTc interval and are associated with Torsades de Pointe (TdP)
• Previous cancer treatment up to 21 days before first dose
• Any investigational therapy up to 28 days before Cycle 1 Day 1
• Known allergy to cyclodextrins

Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if all study criteria are met.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Dose escalating cohorts of SNS-314

Experimental group

Description:

Sequential groups, starting at a dose of 30 mg/m2, will be escalated according to identification of dose limiting toxicities against various criteria. Doses escalated by doubling the dose until the first observation of clinically significant Grade 2 or greater toxicity related to SNS-314 injection. Results in dosing increments of 67%, 50%, 40%, 33%, and subsequently 25% based on modified Fibonacci schema.

Treatment:

Drug: SNS-314