Safety and Efficacy Clinical Study of SNS-595 in Patients With Advanced Small Cell Lung Cancer
Condition: Carcinoma, Small Cell; Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Small Cell
Intervention: SNS-595
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung; Squamous Cell; Small Cell; Carcinoma; Cancer; Small Cell Lung Cancer

Summary:

      The purpose of this study is to evaluate the objective tumor response rate to SNS-595 in
      patients with small cell lung cancer (SCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to understand and willing to sign a written informed consent document

          -  Patients who have recurrent or refractory SCLC requiring second-line chemotherapy who
             previously received first-line chemotherapy

          -  Measurable disease

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2

          -  Brain metastasis may be included if the patient is neurologically stable and has been
             off steroids and anticonvulsants for at least 4 weeks prior to Cycle 1 Day 0

          -  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, other than
             non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostatic
             intraepithelial neoplasia

          -  Q-wave myocardial infarction or cerebrovascular accident/transient ischemic attack
             (TIA) within 6 months before the first SNS-595 dose

          -  Thromboembolic event (deep vein thrombosis or pulmonary embolus) within 28 days 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, mitomycin C, and therapeutic monoclonal
             antibodies 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 25% of bone marrow
             reserve; radiation to the brain is permitted up to 28 days before the first SNS-595
             dose, as long as the patient does not require treatment with corticosteroids for
             symptom control related to brain metastases.

          -  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 or compliance with study procedures