Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205
|ClinicalTrials.gov Identifier: NCT01247922|
Recruitment Status : 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)
First Posted : November 25, 2010
Results First Posted : January 11, 2016
Last Update Posted : June 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ependymoma||Drug: Erlotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label Phase 2 Study of Single-agent Erlotinib for Patients With Pediatric Ependymoma Previously Treated With Oral Etoposide in Protocol OSI-774-205|
|Actual Study Start Date :||May 23, 2011|
|Actual Primary Completion Date :||September 13, 2012|
|Actual Study Completion Date :||September 13, 2012|
Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
continuous oral Erlotinib 85 mg/m^2 per day
- 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) ]Safety is monitored through AEs, which includes abnormal or clinically significant vital sign assessments, laboratory test, physical examination findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention. A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the study drug. An AE was considered serious (SAE) if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events.
- Best Overall Response [ Time Frame: End of treatment (The mean treatment duration was 170.5 days.) ]Best overall response was derived from an integrated clinical assessment by the study investigator as per institutional standards. This included radiographic assessments deemed appropriate by the investigator in the normal care of the patient. A determination of best overall response at the end of study treatment (complete response, partial response, minor response or stable disease) was only made if (1) any disease-related neurologic symptoms were stable or improving over the interval of the radiographic assessment and (2) corticosteroid dosing for the control of tumor-related signs/symptoms was stable or decreasing.If the investigator deems that a radiographic assessment is not needed, then evidence of clinical improvement may be used to determine best response provided that corticosteroid dosing for tumor-related signs/symptoms is stable or decreasing.
- 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) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247922
|Study Director:||Medical Monitor||Astellas Pharma Global Development|