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

NCT00519662 | Completed Phase 1

• 1 other identifier: SPO-0011
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Advanced Solid Tumors

Keywords

Solid; Tumors; Advanced

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of SNS-314

  1 Year

Study Arms (1)

Dose escalating cohorts of SNS-314

EXPERIMENTAL

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.

Drug: SNS-314

Interventions

SNS-314 DRUG

Stage 1 - Escalating doses of SNS-314 Injection on days 1, 8 and 15 Stage 2 - Same as stage 1 except SNS-314 Injection is administered at the maximum tolerated dose established in stage 1

Dose escalating cohorts of SNS-314

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced solid tumor and that is measurable by a scan

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunesis Pharmaceuticals: lead

Study Sites (4)

University of Alabama, Birmingham

Birmingham, Alabama, 35233, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

SNS 314

Study Officials

• Glenn Michelson, MD

  Sunesis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2007
• First Posted: August 22, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 4, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)