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Safety and Efficacy Clinical Study of SNS-595 for Second-Line Therapy in Patients With Advanced NSCLC

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.
 
ClinicalTrials.gov Identifier: NCT00252382
Recruitment Status : Completed
First Posted : November 11, 2005
Results First Posted : June 29, 2017
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Sunesis Pharmaceuticals

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: SNS-595 Injection Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
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 the Intravenous Administration of SNS-595 as Second-Line Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Actual Study Start Date : December 27, 2005
Actual Primary Completion Date : March 5, 2007
Actual Study Completion Date : November 29, 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment with 48 mg/m2 of SNS-595
Patients are treated with 48 mg/m2 of the drug SNS-595 injection once every 21 days for up to 6 cycles as a second -line therapy to patients with advanced non-small cell lung cancer (NSCLC)
 Drug: SNS-595 Injection
Vosaroxin (formerly voreloxin or SNS-595) is a first in class anticancer quinolone derivative, non anthracycline topoisomerase II inhibitor. It induces replication dependent DNA damage by intercalating DNA and inhibiting topoisomerase II, leading to apoptosis.
Other Names:
  • Voreloxin
  • Vosaroxin


Outcome Measures
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Primary Outcome Measures :
  1. Objective Tumor Response Rate [ Time Frame: 168 days ]
    ORR is based on RECIST criteria to SNS-595 as a second-line therapy in patients with advanced NSCLC. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.


Secondary Outcome Measures :
  1. Best Overall Response [ Time Frame: 168 days ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (LD) of target lesions; >=20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions (PD); Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (SD). The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00252382


Locations
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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
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Study Director: Glenn Michelson, MD Sunesis Pharmaceuticals
More Information
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Responsible Party: Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00252382    
Other Study ID Numbers: SPO-0005
First Posted: November 11, 2005    Key Record Dates
Results First Posted: June 29, 2017
Last Update Posted: September 24, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Sunesis Pharmaceuticals:
Lung
Squamous Cell
Large Cell
 Adenocarcinoma
Carcinoma
Cancer
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases