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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016836-11 | EudraCT Number |
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In a pre-planned interim analysis, OSI-774-205 met futility for efficacy with no safety concerns. As a result, it has been stopped.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Dept. of Pediatric-Hematology/Oncology | Birmingham | Alabama | 35233 | United States | ||
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| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results website | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | 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. |
| FG001 | Etoposide |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| etoposide | Drug | oral |
|
|
| From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. |
| 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. | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. |
| 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. | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. |
| 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. | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. |
| 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. | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. |
| 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. | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. |
| 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. | 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. |
| 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. | 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. |
| 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. | Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose. |
| 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. | Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose. |
| 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. | Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose. |
| 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. | Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose. |
| 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. | Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose. |
| Center for Cancer and Blood Disorders-Phoenix Children's Hospital |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Children's Hospital of Orange County (CHOC) | Orange | California | 92868 | United States |
| Stanford University and Lucile Packard Children's Hospital | Palo Alto | California | 94304 | United States |
| Children's Hospital Center for Cancer and Blood Disorders | Aurora | Colorado | 80045 | United States |
| Children's National Medical Center - D.C. Center for Cancer and Blood Disorders | Washington D.C. | District of Columbia | 20010 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Emory University Children's Healthcare of Atlanta Aflac Cancer Center & Blood Disorders | Atlanta | Georgia | 30322 | United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
| Dana-Farber Cancer Institute Department of Pediatric Neuro-oncology | Boston | Massachusetts | 02115 | United States |
| Amplatz Children's Hospital University of Minnesota Medical Center- Pediatric Hematology Oncology | Minneapolis | Minnesota | 55455 | United States |
| Steven D Hassenfeld Children's Center - New York University | New York | New York | 10016 | United States |
| Columbia University Children's Hospital of New York Presbyterian Child & Adolescent Oncology Center | New York | New York | 10032 | United States |
| Oregon Health & Sciences University Doembecher Children's Hospital | Portland | Oregon | 97124 | United States |
| Penn State Hershey Children's Hospital | Hershey | Pennsylvania | 17110 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Children's Medical Center, Dallas Center for Cancer and Blood Disorders | Dallas | Texas | 75235 | United States |
| University of Wisconsin Pediatric Hematology/Oncology Department | Madison | Wisconsin | 53705-2275 | United States |
| Strollery Children's Hospital Division of Hematology/Oncology | Edmonton | Alberta | T6G 2B7 | Canada |
| Children's and Women's Health Center of BC Division of Hematology/ Oncology/ BMT | Vancouver | British Columbia | V6H 3V4 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Birmingham Children's Hospital | Birmingham | B4 6NH | United Kingdom |
| Royal Hospital for Sick Children | Glasgow | G3 8SJ | United Kingdom |
| Paediatric Oncology and Haematology Offices | Leeds | LS1 3EX | United Kingdom |
| Alder Hey Children's NHS Foundation Trust Department of Oncology | Liverpool | L12 1AP | United Kingdom |
| Royal Manchester Children's Hospital Ward 84 | Manchester | M13 9W2 | United Kingdom |
| University of Nottingham Children's Brain Tumour Research Centre | Nottingham | NG7 2UH | United Kingdom |
| Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
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.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | 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. |
| BG001 | Etoposide | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Body Surface Area (BSA) | Mean | Standard Deviation | m^2 |
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| Tumor Type for Initial Disease Diagnosis | Number | participants |
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| Total Number of Disease Recurrences | Median | Full Range | recurrences |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Full Analysis Set (FAS) consisted of all randomized participants. Following the intent-to-treat (ITT) principle, participants were analyzed according to the treatment arm they were assigned to at randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. |
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| Secondary | 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. | Full Analysis Set participants whose best overall response was CR or PR. | Posted | Median | 95% Confidence Interval | days | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. |
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| Secondary | 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. | The Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. |
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| Secondary | 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. | The Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. |
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| Secondary | 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. | The Full Analysis Set | Posted | Median | 95% Confidence Interval | days | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. |
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| Secondary | 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. | The Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. |
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| Secondary | 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. | Full Analysis Set participants whose best overall response was CR, PR, MR or SD. | Posted | Median | 95% Confidence Interval | days | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. |
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| Secondary | 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. | The Full Analysis Set | Posted | Median | 95% Confidence Interval | days | 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. |
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| Secondary | 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. | All enrolled participants who received at least 1 dose of study drug (Safety Analysis Set). | Posted | Number | participants | 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. |
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| Secondary | 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. | The Pharmacokinetics Analysis Set (PKAS) consisted of the participants treated with erlotinib for whom sufficient analyte concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter. Participants may have been excluded from the PKAS for reasons such as missing data or protocol deviation. | Posted | Geometric Mean | 95% Confidence Interval | h*ng/mL | Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose. |
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| Secondary | 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. | The Pharmacokinetics Analysis Set | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose. |
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| Secondary | 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. | The Pharmacokinetics Analysis Set | Posted | Geometric Mean | 95% Confidence Interval | hours | Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose. |
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| Secondary | 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. | The Pharmacokinetics Analysis Set | Posted | Geometric Mean | 95% Confidence Interval | mL/h/m^2 | Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose. |
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| Secondary | 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. | The Pharmacokinetics Analysis Set | Posted | Geometric Mean | 95% Confidence Interval | mL/m^2 | Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose. |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erlotinib | 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. | 6 | 13 | 13 | 13 | ||
| EG001 | Etoposide | 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. | 5 | 12 | 11 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Convulsion | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v13.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v13.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA v13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Lip ulceration | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Hypoaethesia facial | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Skin striae | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Cerebellar syndrome | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Facial palsy | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Hypoaethesia | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Meningism | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Coordination abnormal | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Cranial nerve disorder | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Hypersomnia | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Muscle spasticity | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Tongue paralysis | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Upper motor neurone lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v13.0 | Systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| VIth nerve paralysis | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v13.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v13.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v13.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v13.0 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA v13.0 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA v13.0 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA v13.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v13.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Eye movement disorder | Eye disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Optic nerve disorder | Eye disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Strabismus | Eye disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
| |
| Conjunctivitis infective | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
| |
| Corneal infection | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
| |
| urinary tract infection | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v13.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v13.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v13.0 | Systematic Assessment |
| |
| Anthropod bite | Injury, poisoning and procedural complications | MedDRA v13.0 | Systematic Assessment |
| |
| Catheter site pain | Injury, poisoning and procedural complications | MedDRA v13.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA v13.0 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA v13.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Epistaxis | Vascular disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Multiple allergies | Immune system disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Enuresis | Renal and urinary disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Cushingoid | Endocrine disorders | MedDRA v13.0 | Systematic Assessment |
| |
| Breast enlargement | Reproductive system and breast disorders | MedDRA v13.0 | Systematic Assessment |
|
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.
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Medical Director, Medical Oncology | Astellas Pharma Global Development, Inc | ClinicalTrials.Disclosure@us.astellas.com |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| C531673 | Familial ependymoma |
| D004806 | Ependymoma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Male |
|
| Asian - Southeast Asia |
|
| Black |
|
| Other |
|
| White |
|
| Not Hispanic/Latino |
|
| Ependymoma |
|
| Myxopapillary Ependymoma |
|
|
|
|
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.
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
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.
|
|
|
|
|
|
|