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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.
 
ClinicalTrials.gov Identifier: NCT00298896
Recruitment Status : Completed
First Posted : March 3, 2006
Results First Posted : July 26, 2018
Last Update Posted : July 26, 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 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 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 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 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

Arms and Interventions
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Arm Intervention/treatment
Experimental: SNS-595
SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles.
 Drug: SNS-595
Other Names:
  • Voreloxin
  • Vosaroxin


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: up to 6 months ]
    Objective tumor response rate based on the RECIST criteria for target lesions as assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD), at least a 20% increase in the sum of the LD of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Overall Response (OR) = CR + PR


Secondary Outcome Measures :
  1. Best Overall Response [ Time Frame: upto 6 months ]
    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), classified as CR, PR, SD or PD per RECIST criteria.


Eligibility Criteria
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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.


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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 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
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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): NCT00298896


Locations
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Sponsors and Collaborators
Sunesis Pharmaceuticals
Investigators
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Study Director: Craig Berman, MD Sunesis Pharmaceuticals
More Information
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Responsible Party: Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00298896    
Other Study ID Numbers: SPO-0006
First Posted: March 3, 2006    Key Record Dates
Results First Posted: July 26, 2018
Last Update Posted: July 26, 2018
Last Verified: October 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
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunesis Pharmaceuticals:
Lung
Squamous Cell
Small Cell
 Carcinoma
Cancer
Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
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