Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01174043
First received: July 30, 2010
Last updated: March 18, 2015
Last verified: March 2015
Results First Received: March 18, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia, Myelomonocytic, Acute
Intervention: Drug: Erlotinib

  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
This protocol was based on getting 14 patients. Due to the lack of response, the study was stopped at 11 patients for this pilot study.

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
Erlotinib Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.

Participant Flow:   Overall Study
    Erlotinib  
STARTED     11  
COMPLETED     0  
NOT COMPLETED     11  
Disease progression                 5  
Adverse Event                 3  
Death                 1  
Withdrawal by Subject                 2  



  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
Erlotinib Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.

Baseline Measures
    Erlotinib  
Number of Participants  
[units: participants]
  11  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     10  
Age  
[units: years]
Mean (Standard Deviation)
  76.8  (7.04)  
Gender  
[units: participants]
 
Female     4  
Male     7  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     11  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     11  
More than one race     0  
Unknown or Not Reported     0  



  Outcome Measures
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1.  Primary:   Overall Response Rate (Defined as Partial Remission or Better) to 3 Months of Treatment With Erlotinib   [ Time Frame: 3 months of treatment with erlotinib ]

2.  Secondary:   Duration of Response (up to One Year Follow up) in Patients Who Achieve a Complete Remission   [ Time Frame: 1 year after treatment discontinuation ]

3.  Secondary:   Treatment Related Adverse Events Grade 3 or Higher   [ Time Frame: up to 15 months ]

4.  Other Pre-specified:   Mechanistic Attributes of Erlotinib Hydrochloride in AML, Including Intracellular Quantitative Protein and Gene Expression Modifications and the in Vivo Effect of This Agent on the Differentiation of AML Blasts   [ Time Frame: Baseline; days 3, 4, 8, and 29 of course 1; and day 29 of courses 3, 6, 9, and 12 ]
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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Hamid Sayar
Organization: IndianaU
phone: (317)278-6871
e-mail: ssayar@iu.edu


No publications provided


Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01174043     History of Changes
Other Study ID Numbers: 1006-12; IUCRO-0300
Study First Received: July 30, 2010
Results First Received: March 18, 2015
Last Updated: March 18, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration