Clinical Trial Results:
Open-label, Phase 2 Study of Single-agent Erlotinib for Patients with Pediatric Ependymoma Previously Treated with Oral Etoposide in Protocol OSI-774-205
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Summary
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EudraCT number |
2010-023478-38 |
Trial protocol |
GB |
Global end of trial date |
13 Sep 2012
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Feb 2016
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First version publication date |
12 Jun 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
OSI-774-206
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01247922 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
OSI Pharmaceuticals LLC
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Sponsor organisation address |
1 Astellas Way, Northbrook, IL, United States, 60062
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Public contact |
Clinical Trial Disclosure, Astellas Pharma Global Development, Inc., Astellas.resultsdisclosure@astellas.com
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Scientific contact |
Clinical Trial Disclosure, Astellas Pharma Global Development, Inc., Astellas.resultsdisclosure@astellas.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
13 Sep 2012
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Sep 2012
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Sep 2012
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The primary objective of this study was to assess the safety profile of single-agent erlotinib in patients with recurrent or refractory pediatric ependymoma who were previously treated with oral etoposide in Protocol OSI-774-205.
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Protection of trial subjects |
This clinical study was written, conducted and reported in accordance with the protocol, ICH GCP Guidelines, and applicable local regulations, including the European Directive 2001/20/EC, on the protection of human rights, and with the ethical principles that have their origin in the Declaration of Helsinki.
Astellas ensures that the use and disclosure of protected health information (PHI) obtained during a research study complies with the federal, national and/or regional legislation related to the privacy and protection of personal information.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 May 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 1
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Country: Number of subjects enrolled |
Canada: 3
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Worldwide total number of subjects |
4
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EEA total number of subjects |
1
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
2
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Adolescents (12-17 years) |
2
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
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. | ||||||
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Pre-assignment
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Screening details |
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. | ||||||
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Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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Erlotinib | ||||||
Arm description |
Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred. The number of participants who completed the study has been defined to be the participants who discontinued treatment due to disease progression. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Erlotinib
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Investigational medicinal product code |
OSI-774
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Other name |
Tarceva®
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants received a continuous oral dose of 85 mg/m^2 per day (taken at approximately the same time of day, 1 hour before or 2 hours after meals) until dose modification, interruption or study discontinuation occurred. Erlotinib was either swallowed whole or crushed and mixed with 1 heaping teaspoon of applesauce immediately before administration to the participant. Doses of erlotinib were to be reduced and/or delayed for toxicities at any time during the study. Erlotinib was provided as tablets containing erlotinib hydrochloride equivalent to 150, 100 and 25 mg of erlotinib.
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Baseline characteristics reporting groups
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Reporting group title |
Erlotinib
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Reporting group description |
Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred. The number of participants who completed the study has been defined to be the participants who discontinued treatment due to disease progression. | ||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Erlotinib
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Reporting group description |
Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred. The number of participants who completed the study has been defined to be the participants who discontinued treatment due to disease progression. | ||
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End point title |
Safety assessed through evaluation of physical examinations, vital signs, clinical laboratory tests, and adverse events (AEs) [1] | ||||||||||||||||
End point description |
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.
The analysis population is the Safety Analysis Set (SAF) consisted of all enrolled patients who received at least 1 dose of study drug.
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End point type |
Primary
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End point timeframe |
From first dose of study drug to 30 days after last dose of study drug
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This study was designed to assess the safety profile of single-agent erlotinib in patients with recurrent or refractory pediatric ependymoma who were previously treated with oral etoposide in Protocol OSI-774-205. No formal statistical analysis was performed due to sample size (n=4). |
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End point title |
Best overall response | ||||||||||||||||
End point description |
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. The analysis population is SAF.
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End point type |
Secondary
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End point timeframe |
End of treatment (mean treatment duration was 170.5 days)
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End point title |
Median treatment duration | ||||||
End point description |
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End point type |
Secondary
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End point timeframe |
From first dose of study drug up to last dose of study drug
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Adverse events information
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Timeframe for reporting adverse events |
From first dose of study drug to 30 days after last dose of study drug
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.0
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Reporting groups
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Reporting group title |
Erlotinib
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| The protocol-specified futility criteria were met at the second interim analysis dated 15 Aug 2012 for OSI-774-205. Per the DMC recommendation and FDA’s agreement, the enrollment of patients in that study and Study OSI-774-206 was permanently closed. | |||
