Safety and Efficacy Clinical Study of SNS-595 in Patients With Advanced Small Cell Lung Cancer

Not Recruiting

Trial ID: NCT00298896


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

Official Title

Phase 2 Open-Label, Multicenter Clinical Study of the Safety and Efficacy of Intravenous Administration of SNS-595 in Patients With Advanced Small Cell Lung Cancer (SCLC)

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor


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

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


drug: SNS-595

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Lisa Zhou

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