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

NCT00252382 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SPO-0005
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 4

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Lung; Squamous Cell; Large Cell; Adenocarcinoma; Carcinoma; Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Tumor Response Rate

  ORR is based on RECIST criteria to SNS-595 as a second-line therapy in patients with advanced NSCLC. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  168 days

Secondary Outcomes (1)

• Best Overall Response

  168 days

Study Arms (1)

Treatment with 48 mg/m2 of SNS-595

EXPERIMENTAL

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)

Drug: SNS-595 Injection

Interventions

SNS-595 Injection 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.

Also known as: Voreloxin, Vosaroxin

Treatment with 48 mg/m2 of SNS-595

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunesis Pharmaceuticals: lead

Study Sites (4)

Premiere Oncology of Arizona

Scottsdale, Arizona, 85260, United States

Location

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, 40207, United States

Location

Duke Comprehensive Cancer Center, Duke University

Durham, North Carolina, 27705, United States

Location

Sarah Cannon Research Institute, LLC

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Carcinoma; Neoplasms

Interventions

vosaroxin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Limitations and Caveats

Statistical fields are not included here because no statistical testings were performed to compare any treatment group. No p-values or odds ratios were reported.

Results Point of Contact

• Title: Mike Johnston, Senior Director Regulatory Affairs
• Organization: Sunesis Pharmaceuticals, Inc.

mjohnston@sunesis.com

(650) 266-3727

Study Officials

• Glenn Michelson, MD

  Sunesis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2005
• First Posted: November 11, 2005
• Study Start: December 27, 2005
• Primary Completion: March 5, 2007
• Study Completion: November 29, 2007
• Last Updated: September 24, 2018
• Results First Posted: June 29, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)