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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00252382
First Posted: November 11, 2005
Last Update Posted: June 29, 2017
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.
Information provided by (Responsible Party):
Sunesis Pharmaceuticals
Results First Submitted: April 14, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Intervention: Drug: SNS-595 Injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not applicable. Nothing in protocol specifying exclusion after enrollment but prior to receipt of drug.

Reporting Groups
  Description
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)

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.


Participant Flow:   Overall Study
    Treatment With 48 mg/m2 of SNS-595
STARTED   31 
COMPLETED   5 
NOT COMPLETED   26 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Total Open label administration of SNS-595 48 mg/m2 treatment on day one of 21 day cycles, up to 6 cycles.

Baseline Measures
   Total 
Overall Participants Analyzed 
[Units: Participants]
 31 
Age, Customized [1] 
[Units: Years]
Mean (Standard Deviation)
 
Age   60.4  (9.74) 
[1] Age of participant on entry.
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11  35.5% 
Male      20  64.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      3   9.7% 
White      28  90.3% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Tumor Response Rate   [ Time Frame: 24 months ]

2.  Secondary:   Best Overall Response   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Statistical fields are not included here because no statistical testings were performed to compare any treatment group. No p-values or odds ratios were reported.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Linda Neuman, MD, Vice President, Clinical Development
Organization: Sunesis Pharmaceuticals, Inc.
phone: (650) 266-3760
e-mail: l.neuman@sunesis.com



Responsible Party: Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00252382     History of Changes
Other Study ID Numbers: SPO-0005
First Submitted: November 9, 2005
First Posted: November 11, 2005
Results First Submitted: April 14, 2017
Results First Posted: June 29, 2017
Last Update Posted: June 29, 2017