Safety and Efficacy Clinical Study of SNS-595 for Second-Line Therapy in Patients With Advanced NSCLC

NCT ID: NCT00252382

Last Updated: 2018-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-27
• Study Completion Date: 2007-11-29

Brief Summary

The purpose of this study is to evaluate the objective tumor response rate (based on the RECIST criteria) to SNS-595 as a second-line therapy in patients with advanced NSCLC.

Detailed Description

Other objectives of this study are to assess the safety, tumor response, time to disease progression, survival rate and to explore several potential biomarkers to see how these levels change after administration of SNS-595.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with 48 mg/m2 of SNS-595

Patients are treated with 48 mg/m2 of the drug SNS-595 injection once every 21 days for up to 6 cycles as a second -line therapy to patients with advanced non-small cell lung cancer (NSCLC)

Group Type: EXPERIMENTAL

SNS-595 Injection

Intervention Type: DRUG

Vosaroxin (formerly voreloxin or SNS-595) is a first in class anticancer quinolone derivative, non anthracycline topoisomerase II inhibitor. It induces replication dependent DNA damage by intercalating DNA and inhibiting topoisomerase II, leading to apoptosis.

Interventions

SNS-595 Injection

Vosaroxin (formerly voreloxin or SNS-595) is a first in class anticancer quinolone derivative, non anthracycline topoisomerase II inhibitor. It induces replication dependent DNA damage by intercalating DNA and inhibiting topoisomerase II, leading to apoptosis.

Intervention Type: DRUG

Other Intervention Names

Voreloxin; Vosaroxin

Eligibility Criteria

Inclusion Criteria

• Able to understand and willing to sign a written informed consent document
• Patients who have recurrent or metastatic NSCLC, who have failed initial therapy with a platinum-containing regimen and have not received any second-line therapy (adjuvant therapy is acceptable if it was completed greater than or equal to 12 months before the cancer recurrence)
• Measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• Laboratory Values within the normal or reasonable reference range as specified by the protocol

Exclusion Criteria

• Prior exposure to SNS-595
• Pregnant or breastfeeding
• Women of childbearing potential or male partners of women of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards
• Other active malignancies or other malignancies within the past 12 months except non-melanoma skin cancer, cervical intraepithelial neoplasia or prostatic intraepithelial neoplasia
• Brain metastases, if present, without radiologic evidence of progressive disease for at least 3 months after completion of therapy
• Myocardial infarction, cerebrovascular accident/transient ischemic attack (TIA) or thromboembolic event (deep vein thrombosis or pulmonary embolus) within 6 months before the first SNS-595 dose
• Requires kidney dialysis (hemodialysis or peritoneal)
• Prior chemotherapy, investigational agents, or radiation therapy within 28 days before Cycle 1 Day 0; however, nitrosoureas and mitomycin are not permitted for at least 42 days before Cycle 1 Day 0
• In patients with toxicities caused by prior cancer therapy, those toxicities must have returned to less than or equal to Grade 1, with the exception of alopecia
• Prior pelvic radiation therapy or radiation to greater than or equal to 25% of bone marrow reserve (prior palliative radiation is permitted as long as it does not exceed 25% of bone marrow reserve)
• Any other 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 concerns or compliance with study procedures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunesis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glenn Michelson, MD

Role: STUDY_DIRECTOR

Sunesis Pharmaceuticals

Locations

Premiere Oncology of Arizona

Scottsdale, Arizona, United States

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, United States

Duke Comprehensive Cancer Center, Duke University

Durham, North Carolina, United States

Sarah Cannon Research Institute, LLC

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

SPO-0005

Identifier Type: -

Identifier Source: org_study_id