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

This study has been completed.
Sponsor:
Information provided by:
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00298896
First received: March 1, 2006
Last updated: March 5, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Carcinoma, Small Cell
Small Cell Lung Cancer
Drug: SNS-595 Injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Sunesis Pharmaceuticals:

Primary Outcome Measures:
  • Objective tumor response

Secondary Outcome Measures:
  • Safety
  • Overall survival rate
  • Biomarker correlation to clinical response

Estimated Enrollment: 80
Study Start Date: February 2006
Study Completion Date: June 2008
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298896

Locations
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
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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
The Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
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
Investigators
Study Director: Craig Berman, MD Sunesis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Glenn Michelson, MD, Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00298896     History of Changes
Other Study ID Numbers: SPO-0006
Study First Received: March 1, 2006
Last Updated: March 5, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 20, 2014