Back to resultsErlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma (PETEY)
Primary Purpose
Recurrent or Refractory Pediatric Ependymoma
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
erlotinib
etoposide
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent or Refractory Pediatric Ependymoma focused on measuring pediatric, etoposide, erlotinib, phase 2, ependymoma
Eligibility Criteria
Inclusion Criteria:
- Recurrent of refractory ependymoma or subependymoma
- Performance Status (PS): Lansky ≥ 50% for patients ≤ 10 years of age or Karnofsky ≥ 50% for patients >10 years of age
- Measurable disease, defined as 1 measurable lesion that can be accurately measured in 2 planes that has not received radiation therapy within 12 weeks
- Recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
- ≥ 1 year to ≤ 21 years
- Serum creatinine for patients ≤ 5 years in age is ≤ 0.8 mg/dL or Creatinine Clearance/Glomerular Filtration Rate (GFR) ≥ 70 mL/min/m^2
- Serum creatinine for patients > 5 and ≤ 10 years in age is ≤ 1.0 mg/dL or Creatinine Clearance/GFR ≥ 70 mL/min/m^2
- Serum creatinine for patients > 10 and ≤ 15 years in age is ≤ 1.2 mg/dL or Creatinine Clearance/GFR ≥ 70 mL/min/m^2
- Serum creatinine for patients > 15 years in age is ≤ 1.5 mg/dL or Creatinine Clearance/GFR ≥ 70 mL/min/m^2
- Total bilirubin is ≤ 1.5 x upper limit of normal for age
- Alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
- Absolute neutrophil count > 1000/µL
- Platelet count > 100,000/µL
- Hemoglobin > 8 gm/dL
- Neurologically stable for at least 7 days prior to randomization
- If receiving corticosteroids, patients must be on a stable or decreasing dose for at least 7 days before randomization
- Patients of reproductive potential must agree to proactive effective contraceptive measures for the duration of the study and for at least 90 days after completion of study drug
Exclusion Criteria:
- Previously received epidermal growth factor receptor (EGFR)-targeted therapy
- Previously received oral etoposide
- Received craniospinal radiotherapy within 24 weeks prior to randomization
- Received field radiotherapy to the target lesion within 12 weeks prior to randomization
- Received symptomatic metastatic disease within 14 days prior to randomization
- Received myelosuppressive chemotherapy within 21 days before randomization
- Received growth factors within 7 days prior to randomization
- Participating in another investigational drug trial
- Received a biologic agent within 7 days prior to randomization
- Received a monoclonal antibody within 28 days prior to randomization
- Taking cytochrome P450 (CYP)3A4 or CYP1A2 inhibitors/inducers within 14 days prior to randomization
- Taking proton pump inhibitors within 14 days prior to randomization
- Smoking during treatment
- Pregnant or breast-feeding females
Sites / Locations
- University of Alabama at Birmingham Dept. of Pediatric-Hematology/Oncology
- Center for Cancer and Blood Disorders-Phoenix Children's Hospital
- Children's Hospital of Orange County (CHOC)
- Stanford University and Lucile Packard Children's Hospital
- Children's Hospital Center for Cancer and Blood Disorders
- Children's National Medical Center - D.C. Center for Cancer and Blood Disorders
- University of Miami
- Emory University Children's Healthcare of Atlanta Aflac Cancer Center & Blood Disorders
- Johns Hopkins University School of Medicine
- Dana-Farber Cancer Institute Department of Pediatric Neuro-oncology
- Amplatz Children's Hospital University of Minnesota Medical Center- Pediatric Hematology Oncology
- Steven D Hassenfeld Children's Center - New York University
- Columbia University Children's Hospital of New York Presbyterian Child & Adolescent Oncology Center
- Oregon Health & Sciences University Doembecher Children's Hospital
- Penn State Hershey Children's Hospital
- Children's Hospital of Pittsburgh of UPMC
- Children's Medical Center, Dallas Center for Cancer and Blood Disorders
- University of Wisconsin Pediatric Hematology/Oncology Department
- Strollery Children's Hospital Division of Hematology/Oncology
- Children's and Women's Health Center of BC Division of Hematology/ Oncology/ BMT
- Hospital for Sick Children
- Birmingham Children's Hospital
- Royal Hospital for Sick Children
- Paediatric Oncology and Haematology Offices
- Alder Hey Children's NHS Foundation Trust Department of Oncology
- Royal Manchester Children's Hospital Ward 84
- University of Nottingham Children's Brain Tumour Research Centre
- Royal Marsden Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Erlotinib
Etoposide
Arm Description
Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Outcomes
Primary Outcome Measures
Percentage of Participants With an Objective Response
Objective response is defined as a best overall response of complete response (CR) or partial response (PR), evaluated using modified International Society of Pediatric Oncology Brain, Tumor Subcommittee for the Reporting of Trials criteria. Response was confirmed at least 28 days after the first assessment where the response criteria were met. Response was assessed by magnetic resonance imaging (MRI) every 8 weeks.
CR:
Complete disappearance of all enhancing tumor and mass effect
On a stable or decreasing dose of corticosteroids (or receiving only adrenal replacement doses)
Stable or improving neurologic examination sustained for ≥ 4 weeks
If cerebral spinal fluid (CSF) evaluation was positive, it must become negative (confirmed at least 2 times at consecutive samplings).
PR:
≥ 50% reduction in tumor size by bi-dimensional measurement
On a stable or decreasing dose of corticosteroids
Stable or improving neurologic examination sustained for ≥ 4 weeks.
Secondary Outcome Measures
Duration of Response
Duration of response (complete or partial response [CR/PR]) was defined as the time from the date of the first documented response (CR/PR) to the first documented progression or death due to underlying cancer. If a participant had not progressed or died, the duration of overall response was censored at the date of last adequate disease assessment. Duration of response was only defined for participants whose best overall response was CR or PR.
Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status.
Percentage of Participants With a Minor Response
Participants with a best overall response of minor response (MR), defined as:
≥ 25% to < 50% reduction in tumor size by bi-dimensional measurement
On a stable or decreasing dose of corticosteroids
Stable or improving neurologic examination sustained for ≥ 4 weeks.
Percentage of Participants With Disease Control
Disease control is a best overall response of CR or PR or MR or Stable disease (SD).
CR:
Complete disappearance of all enhancing tumor and mass effect
On a stable or decreasing dose of corticosteroids
Stable or improving neurologic examination sustained for ≥ 4 weeks
If CSF evaluation was positive, it must become negative (confirmed at least 2 times consecutively).
PR:
≥ 50% reduction in tumor size by bi-dimensional measurement
On a stable or decreasing dose of corticosteroids
Stable or improving neurologic examination sustained for ≥ 4 weeks.
MR:
≥ 25% to < 50% reduction in tumor size by bi-dimensional measurement
On a stable or decreasing dose of corticosteroids
Stable or improving neurologic examination sustained for ≥ 4 weeks.
SD:
Neurologic examination is at least stable
Maintenance corticosteroid dose is not increased
MRI meets neither the criteria for minor response nor for progressive disease
Sustained for ≥ 8 weeks.
Progression Free Survival (PFS)
Progression-free survival was defined as the time from randomization to disease progression based on central nervous system (CNS)-specific evaluation criteria as assessed by the investigator or death due to any cause, whichever occurs first.
Participants did not progress or die before the data cutoff date for analysis were censored at the date of last disease assessment (including both radiologic assessment and neurologic assessment) where non-progression was documented. If a participant received any further anticancer therapy without prior documentation of disease progression, the participant was censored at the date of last disease assessment before starting new anti-cancer treatment. Participants were also censored at the date of last disease assessment with no documented progression if patients discontinued treatment for undocumented progression, toxicity or other reason before the data cutoff date for analysis.
Percentage of Participants With Prolonged Stable Disease
Prolonged stable disease (SD) was defined as SD with a duration of at least 16 weeks. The percentage of participants with prolonged SD was defined as participants who achieved a best overall response of CR or PR or MR or SD, and did not progress within 16 weeks from randomization. Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status.
Duration of Stable Disease
Duration of stable disease (SD; defined as participants with an overall best response of complete, partial or minor response or stable disease) was defined as the time from the date of randomization to the first documented progression or death due to underlying cancer. If a participant had not progressed or died, the duration of SD was censored at the date of last adequate disease assessment. Duration of SD was only defined for participants whose best overall response was CR or PR or MR or SD.
Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status.
Overall Survival (OS)
Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive by the data cutoff date for analysis were censored on the last day the participant was known to be alive.
Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment. Clinically significant vital sign assessments, findings on physical or neurological examination, and laboratory findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention were recorded as AEs.
An AE was considered serious 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 relationship of each AE to study drug was assessed as either related or not related.
Area Under the Curve From Time 0 to 24 Hours Post-dose for Erlotinib
Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Area under the plasma concentration-time curve from time zero to 24 hours (the dosing interval) measured at steady state using sparse sampling.
Maximum Observed Plasma Concentration of Erlotinib (Cmax)
Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Maximum observed plasma concentration of erlotinib (Cmax) was measured at steady state on Day 14 using sparse sampling.
Time to Maximum Observed Plasma Concentration of Erlotinib (Tmax)
Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Time to the maximum observed plasma concentration of erlotinib (Tmax) was measured at steady state on Day 14 using sparse sampling.
Apparent Body Clearance (CL/F) of Erlotinib
Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Apparent body clearance (CL/F) of erlotinib was measured at steady state on Day 14 using sparse sampling.
Apparent Volume of Distribution (Vz/F) of Erlotinib
Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. The apparent volume of distribution (Vz/F) of erlotinib was measured at steady state on Day 14 using sparse sampling.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01032070
Brief Title
Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma
Acronym
PETEY
Official Title
A Randomized, Phase 2 Study of Single-agent Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
In a pre-planned interim analysis, OSI-774-205 met futility for efficacy with no safety concerns. As a result, it has been stopped.
Study Start Date
September 27, 2010 (Actual)
Primary Completion Date
November 26, 2012 (Actual)
Study Completion Date
November 26, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OSI Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a phase 2 study to evaluate the efficacy of single-agent erlotinib versus oral etoposide in patients with recurrent or refractory pediatric ependymoma.
Detailed Description
This is a phase 2 study involving a 1:1 randomization of 40 patients with recurrent or refractory pediatric ependymoma who will receive either erlotinib or oral etoposide.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent or Refractory Pediatric Ependymoma
Keywords
pediatric, etoposide, erlotinib, phase 2, ependymoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erlotinib
Arm Type
Experimental
Arm Description
Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Arm Title
Etoposide
Arm Type
Active Comparator
Arm Description
Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
Intervention Type
Drug
Intervention Name(s)
erlotinib
Other Intervention Name(s)
OSI-774, Tarceva
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
etoposide
Other Intervention Name(s)
VP-16
Intervention Description
oral
Primary Outcome Measure Information:
Title
Percentage of Participants With an Objective Response
Description
Objective response is defined as a best overall response of complete response (CR) or partial response (PR), evaluated using modified International Society of Pediatric Oncology Brain, Tumor Subcommittee for the Reporting of Trials criteria. Response was confirmed at least 28 days after the first assessment where the response criteria were met. Response was assessed by magnetic resonance imaging (MRI) every 8 weeks.
CR:
Complete disappearance of all enhancing tumor and mass effect
On a stable or decreasing dose of corticosteroids (or receiving only adrenal replacement doses)
Stable or improving neurologic examination sustained for ≥ 4 weeks
If cerebral spinal fluid (CSF) evaluation was positive, it must become negative (confirmed at least 2 times at consecutive samplings).
PR:
≥ 50% reduction in tumor size by bi-dimensional measurement
On a stable or decreasing dose of corticosteroids
Stable or improving neurologic examination sustained for ≥ 4 weeks.
Time Frame
From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Secondary Outcome Measure Information:
Title
Duration of Response
Description
Duration of response (complete or partial response [CR/PR]) was defined as the time from the date of the first documented response (CR/PR) to the first documented progression or death due to underlying cancer. If a participant had not progressed or died, the duration of overall response was censored at the date of last adequate disease assessment. Duration of response was only defined for participants whose best overall response was CR or PR.
Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status.
Time Frame
From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Title
Percentage of Participants With a Minor Response
Description
Participants with a best overall response of minor response (MR), defined as:
≥ 25% to < 50% reduction in tumor size by bi-dimensional measurement
On a stable or decreasing dose of corticosteroids
Stable or improving neurologic examination sustained for ≥ 4 weeks.
Time Frame
From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Title
Percentage of Participants With Disease Control
Description
Disease control is a best overall response of CR or PR or MR or Stable disease (SD).
CR:
Complete disappearance of all enhancing tumor and mass effect
On a stable or decreasing dose of corticosteroids
Stable or improving neurologic examination sustained for ≥ 4 weeks
If CSF evaluation was positive, it must become negative (confirmed at least 2 times consecutively).
PR:
≥ 50% reduction in tumor size by bi-dimensional measurement
On a stable or decreasing dose of corticosteroids
Stable or improving neurologic examination sustained for ≥ 4 weeks.
MR:
≥ 25% to < 50% reduction in tumor size by bi-dimensional measurement
On a stable or decreasing dose of corticosteroids
Stable or improving neurologic examination sustained for ≥ 4 weeks.
SD:
Neurologic examination is at least stable
Maintenance corticosteroid dose is not increased
MRI meets neither the criteria for minor response nor for progressive disease
Sustained for ≥ 8 weeks.
Time Frame
From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Title
Progression Free Survival (PFS)
Description
Progression-free survival was defined as the time from randomization to disease progression based on central nervous system (CNS)-specific evaluation criteria as assessed by the investigator or death due to any cause, whichever occurs first.
Participants did not progress or die before the data cutoff date for analysis were censored at the date of last disease assessment (including both radiologic assessment and neurologic assessment) where non-progression was documented. If a participant received any further anticancer therapy without prior documentation of disease progression, the participant was censored at the date of last disease assessment before starting new anti-cancer treatment. Participants were also censored at the date of last disease assessment with no documented progression if patients discontinued treatment for undocumented progression, toxicity or other reason before the data cutoff date for analysis.
Time Frame
From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Title
Percentage of Participants With Prolonged Stable Disease
Description
Prolonged stable disease (SD) was defined as SD with a duration of at least 16 weeks. The percentage of participants with prolonged SD was defined as participants who achieved a best overall response of CR or PR or MR or SD, and did not progress within 16 weeks from randomization. Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status.
Time Frame
From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Title
Duration of Stable Disease
Description
Duration of stable disease (SD; defined as participants with an overall best response of complete, partial or minor response or stable disease) was defined as the time from the date of randomization to the first documented progression or death due to underlying cancer. If a participant had not progressed or died, the duration of SD was censored at the date of last adequate disease assessment. Duration of SD was only defined for participants whose best overall response was CR or PR or MR or SD.
Progression was defined as a worsening of neurologic status that could not be explained by other causes, a > 25% increase in tumor size, the appearance of new lesions or CSF positivity, or increasing doses of corticosteroids required to maintain stable status.
Time Frame
From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Title
Overall Survival (OS)
Description
Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive by the data cutoff date for analysis were censored on the last day the participant was known to be alive.
Time Frame
From randomization up to 12 months after the last dose. Median duration of follow-up was 12.9 months for erlotinib and 14.4 months for etoposide.
Title
Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs)
Description
An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment. Clinically significant vital sign assessments, findings on physical or neurological examination, and laboratory findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention were recorded as AEs.
An AE was considered serious 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 relationship of each AE to study drug was assessed as either related or not related.
Time Frame
From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 52 days for erlotinib and 58 days for etoposide.
Title
Area Under the Curve From Time 0 to 24 Hours Post-dose for Erlotinib
Description
Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Area under the plasma concentration-time curve from time zero to 24 hours (the dosing interval) measured at steady state using sparse sampling.
Time Frame
Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.
Title
Maximum Observed Plasma Concentration of Erlotinib (Cmax)
Description
Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Maximum observed plasma concentration of erlotinib (Cmax) was measured at steady state on Day 14 using sparse sampling.
Time Frame
Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.
Title
Time to Maximum Observed Plasma Concentration of Erlotinib (Tmax)
Description
Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Time to the maximum observed plasma concentration of erlotinib (Tmax) was measured at steady state on Day 14 using sparse sampling.
Time Frame
Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.
Title
Apparent Body Clearance (CL/F) of Erlotinib
Description
Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. Apparent body clearance (CL/F) of erlotinib was measured at steady state on Day 14 using sparse sampling.
Time Frame
Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.
Title
Apparent Volume of Distribution (Vz/F) of Erlotinib
Description
Pharmacokinetic parameters were determined from the serial plasma concentration data obtained for erlotinib. The apparent volume of distribution (Vz/F) of erlotinib was measured at steady state on Day 14 using sparse sampling.
Time Frame
Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recurrent of refractory ependymoma or subependymoma
Performance Status (PS): Lansky ≥ 50% for patients ≤ 10 years of age or Karnofsky ≥ 50% for patients >10 years of age
Measurable disease, defined as 1 measurable lesion that can be accurately measured in 2 planes that has not received radiation therapy within 12 weeks
Recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
≥ 1 year to ≤ 21 years
Serum creatinine for patients ≤ 5 years in age is ≤ 0.8 mg/dL or Creatinine Clearance/Glomerular Filtration Rate (GFR) ≥ 70 mL/min/m^2
Serum creatinine for patients > 5 and ≤ 10 years in age is ≤ 1.0 mg/dL or Creatinine Clearance/GFR ≥ 70 mL/min/m^2
Serum creatinine for patients > 10 and ≤ 15 years in age is ≤ 1.2 mg/dL or Creatinine Clearance/GFR ≥ 70 mL/min/m^2
Serum creatinine for patients > 15 years in age is ≤ 1.5 mg/dL or Creatinine Clearance/GFR ≥ 70 mL/min/m^2
Total bilirubin is ≤ 1.5 x upper limit of normal for age
Alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
Absolute neutrophil count > 1000/µL
Platelet count > 100,000/µL
Hemoglobin > 8 gm/dL
Neurologically stable for at least 7 days prior to randomization
If receiving corticosteroids, patients must be on a stable or decreasing dose for at least 7 days before randomization
Patients of reproductive potential must agree to proactive effective contraceptive measures for the duration of the study and for at least 90 days after completion of study drug
Exclusion Criteria:
Previously received epidermal growth factor receptor (EGFR)-targeted therapy
Previously received oral etoposide
Received craniospinal radiotherapy within 24 weeks prior to randomization
Received field radiotherapy to the target lesion within 12 weeks prior to randomization
Received symptomatic metastatic disease within 14 days prior to randomization
Received myelosuppressive chemotherapy within 21 days before randomization
Received growth factors within 7 days prior to randomization
Participating in another investigational drug trial
Received a biologic agent within 7 days prior to randomization
Received a monoclonal antibody within 28 days prior to randomization
Taking cytochrome P450 (CYP)3A4 or CYP1A2 inhibitors/inducers within 14 days prior to randomization
Taking proton pump inhibitors within 14 days prior to randomization
Smoking during treatment
Pregnant or breast-feeding females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham Dept. of Pediatric-Hematology/Oncology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Center for Cancer and Blood Disorders-Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Children's Hospital of Orange County (CHOC)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford University and Lucile Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Children's Hospital Center for Cancer and Blood Disorders
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's National Medical Center - D.C. Center for Cancer and Blood Disorders
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University Children's Healthcare of Atlanta Aflac Cancer Center & Blood Disorders
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Dana-Farber Cancer Institute Department of Pediatric Neuro-oncology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Amplatz Children's Hospital University of Minnesota Medical Center- Pediatric Hematology Oncology
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Steven D Hassenfeld Children's Center - New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Children's Hospital of New York Presbyterian Child & Adolescent Oncology Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Oregon Health & Sciences University Doembecher Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97124
Country
United States
Facility Name
Penn State Hershey Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Children's Medical Center, Dallas Center for Cancer and Blood Disorders
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University of Wisconsin Pediatric Hematology/Oncology Department
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705-2275
Country
United States
Facility Name
Strollery Children's Hospital Division of Hematology/Oncology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Children's and Women's Health Center of BC Division of Hematology/ Oncology/ BMT
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Birmingham Children's Hospital
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Glasgow
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Facility Name
Paediatric Oncology and Haematology Offices
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Alder Hey Children's NHS Foundation Trust Department of Oncology
City
Liverpool
ZIP/Postal Code
L12 1AP
Country
United Kingdom
Facility Name
Royal Manchester Children's Hospital Ward 84
City
Manchester
ZIP/Postal Code
M13 9W2
Country
United Kingdom
Facility Name
University of Nottingham Children's Brain Tumour Research Centre
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=328
Description
Link to results on Astellas Clinical Study Results website
Learn more about this trial
Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma
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