Safety and Efficacy Clinical Study of SNS-595 for Second-Line Therapy in Patients With Advanced NSCLC
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: SNS-595 Injection
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung; Squamous Cell; Large Cell; Adenocarcinoma; Carcinoma; Cancer

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.
    

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