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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00298896
Recruitment Status : Completed
First Posted : March 3, 2006
Last Update Posted : March 6, 2009
Information provided by:
Sunesis Pharmaceuticals

Brief 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).

Condition or disease Intervention/treatment Phase
Carcinoma, Small Cell Small Cell Lung Cancer Drug: SNS-595 Injection Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : February 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. Objective tumor response

Secondary Outcome Measures :
  1. Safety
  2. Overall survival rate
  3. Biomarker correlation to clinical response

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00298896

United States, California
University of California Davis
Sacramento, California, United States, 95817
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
The Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Canada, Quebec
Hopital Charles LeMoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Laval
Sainte-Foy, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Sunesis Pharmaceuticals
Study Director: Craig Berman, MD Sunesis Pharmaceuticals

Responsible Party: Glenn Michelson, MD, Sunesis Pharmaceuticals Identifier: NCT00298896     History of Changes
Other Study ID Numbers: SPO-0006
First Posted: March 3, 2006    Key Record Dates
Last Update Posted: March 6, 2009
Last Verified: March 2009

Keywords provided by Sunesis Pharmaceuticals:
Squamous Cell
Small Cell
Small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Small Cell
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type