Phase II Study Evaluating The Safety And Response To Neoadjuvant Dasatinib In Early Stage Non-Small Cell Lung Cancer (TOP0706)

This study has been terminated.
(Lack of accrual, study closed.)
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00564876
First received: November 26, 2007
Last updated: March 5, 2013
Last verified: February 2013
Results First Received: February 16, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Intervention: Drug: Dasatinib

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Due to poor enrollment, this trial was closed to accrual and thus no results came from this trial.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Neoadjuvant Dasatinib Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.

Participant Flow:   Overall Study
    Neoadjuvant Dasatinib  
STARTED     2  
COMPLETED     2  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Neoadjuvant Dasatinib Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.

Baseline Measures
    Neoadjuvant Dasatinib  
Number of Participants  
[units: participants]
  2  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  61  ± 2  
Gender  
[units: participants]
 
Female     1  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     2  
Dasatinib [1]
[units: participants]
  2  
[1] 70 mg dasatinib orally twice daily for 3 weeks



  Outcome Measures

1.  Primary:   Response Rate   [ Time Frame: First progression and survival every 3 months for 2 years, then every 6 months until 5 years, then yearly. ]

2.  Secondary:   Safety and Tolerability of Neoadjuvant Dasatinib   [ Time Frame: Screening / Baseline; Neoadjuvant dasatinib Cycle 1 Day 1 and Day 22 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Gene Expression Profile Activation of Src Pathways   [ Time Frame: Baseline and after 3 weeks of dasatinib therapy at the time of definitive surgical resection. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Safety and Tolerability of Adjuvant Dasatinib   [ Time Frame: Duration of adjuvant treatment plus 30 days. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
Limitations for this trial were the trial was stopped due to poor enrollment.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Neal Ready, MD
Organization: Duke University Medical Center
phone: 919-668-6688
e-mail: neal.ready@duke.edu


Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00564876     History of Changes
Other Study ID Numbers: Pro00001278
Study First Received: November 26, 2007
Results First Received: February 16, 2011
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board