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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)

Phase 2
18 Years
Not Enrolling
Carcinoma, Small Cell, Small Cell Lung Cancer

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Trial Information

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)

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response

Principal Investigator

Craig Berman, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sunesis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

June 2008

Related Keywords:

  • Carcinoma, Small Cell
  • Small Cell Lung Cancer
  • Lung
  • Squamous Cell
  • Small Cell
  • Carcinoma
  • Cancer
  • Small Cell Lung Cancer
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Stanford University Medical Center Stanford, California  94305-5408
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Rush University Medical Center Chicago, Illinois  60612-3824
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Duke University Medical Center Durham, North Carolina  27710
Sarah Cannon Research Institute Nashville, Tennessee  37203
University of California Davis Sacramento, California  95817
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University Baltimore, Maryland  21231
The Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232