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Safety and Efficacy Clinical Study of SNS-595 for Second-Line Therapy in Patients With Advanced NSCLC
This study has been completed.
Sponsored by: Sunesis Pharmaceuticals
Information provided by: Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00252382
  Purpose

The purpose of this study is to evaluate the objective tumor response rate (based on the RECIST criteria) to SNS-595 as a second-line therapy in patients with advanced NSCLC.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: SNS-595 Injection
Phase II

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase 2 Open-Label, Multicenter Clinical Study of the Safety and Efficacy of the Intravenous Administration of SNS-595 as Second-Line Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Further study details as provided by Sunesis Pharmaceuticals:

Primary Outcome Measures:
  • Efficacy
  • Safety

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

Estimated Enrollment: 50
Study Start Date: November 2005
Estimated Study Completion Date: April 2007
Detailed Description:

Other objectives of this study are to assess the safety, tumor response, time to disease progression, survival rate 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 metastatic NSCLC, who have failed initial therapy with a platinum-containing regimen and have not received any second-line therapy (adjuvant therapy is acceptable if it was completed greater than or equal to 12 months before the cancer recurrence)
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • 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 except non-melanoma skin cancer, cervical intraepithelial neoplasia or prostatic intraepithelial neoplasia
  • Brain metastases, if present, without radiologic evidence of progressive disease for at least 3 months after completion of therapy
  • Myocardial infarction, cerebrovascular accident/transient ischemic attack (TIA) or thromboembolic event (deep vein thrombosis or pulmonary embolus) within 6 months 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 and mitomycin 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 or equal to 25% of bone marrow reserve (prior palliative radiation is permitted as long as it does not exceed 25% of bone marrow reserve)
  • 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 concerns or compliance with study procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252382

Locations
United States, Arizona
Premiere Oncology of Arizona
Scottsdale, Arizona, United States, 85260
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, North Carolina
Duke Comprehensive Cancer Center, Duke University
Durham, North Carolina, United States, 27705
United States, Tennessee
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Sunesis Pharmaceuticals
Investigators
Study Director: Glenn Michelson, MD Sunesis Pharmaceuticals
  More Information

Study ID Numbers: SPO-0005
Study First Received: November 9, 2005
Last Updated: May 9, 2007
ClinicalTrials.gov Identifier: NCT00252382  
Health Authority: United States: Food and Drug Administration

Keywords provided by Sunesis Pharmaceuticals:
Lung
Squamous Cell
Large Cell
Adenocarcinoma
Carcinoma
Cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009