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

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ClinicalTrials.gov Identifier: NCT01174043
Recruitment Status : Completed
First Posted : August 3, 2010
Results First Posted : March 27, 2015
Last Update Posted : March 27, 2015
OSI Pharmaceuticals
Information provided by (Responsible Party):
Indiana University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Leukemia, Myelomonocytic, Acute
Intervention: Drug: Erlotinib

  Participant Flow

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
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
Disease progression                5 
Adverse Event                3 
Death                1 
Withdrawal by Subject                2 

  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
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
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   1 
>=65 years   10 
[Units: Years]
Mean (Standard Deviation)
 76.8  (7.04) 
[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

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.  

  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
No text entered.

  More Information

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

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01174043     History of Changes
Other Study ID Numbers: 1006-12; IUCRO-0300
First Submitted: July 30, 2010
First Posted: August 3, 2010
Results First Submitted: March 18, 2015
Results First Posted: March 27, 2015
Last Update Posted: March 27, 2015