Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma

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. Identifier: NCT01488318
Recruitment Status : Terminated (PI leaving the institution)
First Posted : December 8, 2011
Results First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Bristol-Myers Squibb
Information provided by (Responsible Party):
Julie E. Bauman, MD, MPH, University of Pittsburgh

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Squamous Cell Carcinoma Of The Head And Neck
Interventions: Drug: Cetuximab
Drug: Dasatinib

  Participant Flow

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
CETUXIMAB + DASATINIB Cetuximab dosed at 250 mg/m^2/week and Dasatinib dosed at 150 mg daily

Participant Flow:   Overall Study

  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.
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Reporting Groups
CETUXIMAB + DASATINIB No text entered.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (51.7 to 72.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      2  14.3% 
Male      12  85.7% 

  Outcome Measures

1.  Primary:   Overall Response Rate (ORR)   [ Time Frame: Up to 36 months ]

2.  Primary:   Response to Treatment   [ Time Frame: Up to 36 months ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Up to 36 months ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 60 months ]

  Serious Adverse Events

  Other Adverse Events

  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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Barbara Stadterman, Regulatory Supervisor
Organization: University of Pittsburgh Cancer Institute
phone: 414-647-5554

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Julie E. Bauman, MD, MPH, University of Pittsburgh Identifier: NCT01488318     History of Changes
Other Study ID Numbers: 08-034
CA180264 ( Other Identifier: BMS )
First Submitted: November 30, 2011
First Posted: December 8, 2011
Results First Submitted: November 8, 2017
Results First Posted: January 5, 2018
Last Update Posted: January 5, 2018