AZD0530 to Treat Recurrent Stage IIIB/IV NSCLC Previously Treated With Combination Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00638937
First received: March 18, 2008
Last updated: June 22, 2015
Last verified: October 2013
Results First Received: August 28, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Intervention: Drug: saracatinib

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment (Saracatinib)

Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression

saracatinib: 175mg given PO daily

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Saracatinib)  
STARTED     37  
COMPLETED     37  
NOT COMPLETED     0  



  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.
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Reporting Groups
  Description
Treatment (Saracatinib)

Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression

saracatinib: Given PO

laboratory biomarker analysis: Correlative studies


Baseline Measures
    Treatment (Saracatinib)  
Number of Participants  
[units: participants]
  37  
Age  
[units: years]
Median (Full Range)
  65   (33 to 78)  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     18  
>=65 years     19  
Gender  
[units: participants]
 
Female     28  
Male     9  
Region of Enrollment  
[units: participants]
 
Canada     37  



  Outcome Measures
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1.  Primary:   Rate of Disease Control (Freedom From Disease Progression)   [ Time Frame: 112 days ]

2.  Secondary:   Objective Response Rate (Complete and Partial Response)   [ Time Frame: From the start of the treatment until the criteria for response are met ]

3.  Secondary:   Stable Disease Rate   [ Time Frame: From the start of the treatment until the criteria for progression are met, assessed up to 1 year ]

4.  Secondary:   Duration of Response or Stable Disease   [ Time Frame: From first response until the criteria for progression are met, assessed up to 1 year ]

5.  Secondary:   Progression-free Survival   [ Time Frame: 6 months ]

6.  Secondary:   Median Overall Survival   [ Time Frame: Up to 1 year ]

7.  Secondary:   Overall Survival   [ Time Frame: 1 year ]

8.  Secondary:   Median Progression-free Survival   [ Time Frame: From the date of study enrollment to the time the criteria for disease progression are met, death or last contact, or the last tumor assessment before the initiation of further anticancer therapy, assessed up to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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  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 more than 60 days but less than or equal to 180 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: Dr. Scott Laurie
Organization: The Ottawa Hospital Cancer Centre
phone: 613-737-7700 ext 70175
e-mail: slaurie@ottawahospital.on.ca


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00638937     History of Changes
Other Study ID Numbers: NCI-2009-01053, NCI-2009-01053, PMH-PHLO-053, CDR0000587610, PHL-053, 7555, N01CM00032, N01CM62203
Study First Received: March 18, 2008
Results First Received: August 28, 2014
Last Updated: June 22, 2015
Health Authority: United States: Food and Drug Administration