Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205

This study has been terminated.
(In a pre-planned interim analysis, OSI-774-205 met futility for efficacy with no safety concerns. As a result, the companion trial, OSI-774-206 has been stopped)
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01247922
First received: November 23, 2010
Last updated: December 7, 2015
Last verified: December 2015
Results First Received: October 26, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ependymoma
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
Participants recruited for this OSI-774-206 study were participants with pediatric ependymoma previously treated with oral etoposide in Study OSI-774-205 who progressed while on study or discontinued due to unacceptable toxicity.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who consented to enter this OSI-774-206 study and fulfilled all the eligibility criteria (no more than 14 days prior to registration) were enrolled in this study no more than 21 days from the last dose of oral etoposide in Study OSI-774-205.

Reporting Groups
  Description
Erlotinib Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.

Participant Flow:   Overall Study
    Erlotinib  
STARTED     4  
Treated     4  
COMPLETED     0  
NOT COMPLETED     4  
Disease progression                 4  



  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 Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.

Baseline Measures
    Erlotinib  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     4  
Between 18 and 65 years     0  
>=65 years     0  
Gender  
[units: participants]
 
Female     1  
Male     3  
Race/Ethnicity, Customized  
[units: participants]
 
White     3  
Asian-Indian subcontinent     1  



  Outcome Measures
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1.  Primary:   Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)   [ Time Frame: From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days) ]

2.  Secondary:   Best Overall Response   [ Time Frame: End of treatment (The mean treatment duration was 170.5 days.) ]

3.  Secondary:   Median Treatment Duration   [ Time Frame: From first dose of study drug up to last dose of study drug (The mean treatment duration was 170.5 days) ]


  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
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sr. Medical Director
Organization: Astellas Pharma Global Development, Inc.
e-mail: Astellas.resultsdisclosure@astellas.com



Responsible Party: Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01247922     History of Changes
Other Study ID Numbers: OSI-774-206
2010-023478-38 ( EudraCT Number )
Study First Received: November 23, 2010
Results First Received: October 26, 2015
Last Updated: December 7, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency