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Cetuximab and Dasatinib in Recurrent Squamous Cell Carcinoma

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
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
No text entered.

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

Participant Flow:   Overall Study
    CETUXIMAB + DASATINIB
STARTED   14 
COMPLETED   14 
NOT COMPLETED   0 



  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
CETUXIMAB + DASATINIB No text entered.

Baseline Measures
   CETUXIMAB + DASATINIB 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Years]
Median (Full Range)
 62 
 (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
e-mail: stadtermanbm@upmc.edu


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

Responsible Party: Julie E. Bauman, MD, MPH, University of Pittsburgh
ClinicalTrials.gov 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