Trial · NCT01032070
Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma
NCT01032070, Phase 2, Terminated, OSI Pharmaceuticals; results first posted 2014-01-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma. Trials, record NCT01032070. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01032070
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma
- NCT number
- NCT01032070
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- OSI Pharmaceuticals
- Conditions
- Recurrent or Refractory Pediatric Ependymoma
- Interventions
- erlotinib, etoposide
- First posted
- 2009-12-15
- Last updated
- 2024-12-12
- Other registries' IDs
- eudract:2009-016836-11
- Results first posted
- 2014-01-08
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With an Objective Response | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. | 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 | Duration of Response | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. | 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. |
| Secondary | Percentage of Participants With a Minor Response | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. | 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. |
| Secondary | Percentage of Participants With Disease Control | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. | 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. |
| Secondary | Progression Free Survival (PFS) | 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 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. |
| Secondary | Percentage of Participants With Prolonged Stable Disease | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. | 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. |
| Secondary | Duration of Stable Disease | 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 (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. |
| Secondary | Overall Survival (OS) | 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. | 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. |
| Secondary | Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs) | 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. | 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. |
| Secondary | Area Under the Curve From Time 0 to 24 Hours Post-dose for Erlotinib | Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose. | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With an Objective Response | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. | 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. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. | Full Analysis Set participants whose best overall response was CR or PR. | days | MEDIAN |
| SECONDARY | Percentage of Participants With a Minor Response | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. | The Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. | The Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. | The Full Analysis Set | days | MEDIAN |
| SECONDARY | Percentage of Participants With Prolonged Stable Disease | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. | The Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Duration of Stable Disease | From randomization until the end of treatment. The median time on treatment was 52 days for erlotinib and 58 days for etoposide. | Full Analysis Set participants whose best overall response was CR, PR, MR or SD. | days | MEDIAN |
| SECONDARY | Overall Survival (OS) | 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. | The Full Analysis Set | days | MEDIAN |
| SECONDARY | Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs) | 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. | All enrolled participants who received at least 1 dose of study drug (Safety Analysis Set). | participants | NUMBER |
| SECONDARY | Area Under the Curve From Time 0 to 24 Hours Post-dose for Erlotinib | Day 14 predose and 0.5 to 1.5 hours, 2 to 3 hours and 4 to 8 hours post-dose. | 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. | h*ng/mL | GEOMETRIC_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With an Objective Response | Erlotinib | 0 | 95% Confidence Interval 0 to 24.7 | percentage of participants | |
| Percentage of Participants With an Objective Response | Etoposide | 16.7 | 95% Confidence Interval 2.1 to 48.4 | percentage of participants | |
| Duration of Response | Etoposide | NA | 95% Confidence Interval NA to NA | days | |
| Percentage of Participants With a Minor Response | Erlotinib | 0 | 95% Confidence Interval 0 to 24.7 | percentage of participants | |
| Percentage of Participants With a Minor Response | Etoposide | 25.0 | 95% Confidence Interval 5.5 to 57.2 | percentage of participants | |
| Percentage of Participants With Disease Control | Erlotinib | 15.4 | 95% Confidence Interval 1.9 to 45.4 | percentage of participants | |
| Percentage of Participants With Disease Control | Etoposide | 41.7 | 95% Confidence Interval 15.2 to 72.3 | percentage of participants | |
| Progression Free Survival (PFS) | Erlotinib | 52 | 95% Confidence Interval 29.0 to 62.0 | days | |
| Progression Free Survival (PFS) | Etoposide | 65 | 95% Confidence Interval 23.0 to NA | days | |
| Percentage of Participants With Prolonged Stable Disease | Erlotinib | 0 | 95% Confidence Interval 0 to 24.7 | percentage of participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Erlotinib | 13 | |
| Overall Study | STARTED | Etoposide | 12 | |
| Overall Study | COMPLETED | Erlotinib | 0 | |
| Overall Study | COMPLETED | Etoposide | 0 | |
| Overall Study | NOT COMPLETED | Erlotinib | 13 | |
| Overall Study | NOT COMPLETED | Etoposide | 12 |
Source ClinicalTrials.gov
Adverse events316
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Erlotinib | 6 | 13 | |
| other | Diarrhoea | Gastrointestinal disorders | Etoposide | 4 | 12 | |
| other | Vomiting | Gastrointestinal disorders | Erlotinib | 6 | 13 | |
| other | Vomiting | Gastrointestinal disorders | Etoposide | 8 | 12 | |
| other | Constipation | Gastrointestinal disorders | Erlotinib | 3 | 13 | |
| other | Constipation | Gastrointestinal disorders | Etoposide | 6 | 12 | |
| other | Nausea | Gastrointestinal disorders | Erlotinib | 3 | 13 | |
| other | Nausea | Gastrointestinal disorders | Etoposide | 5 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | Erlotinib | 2 | 13 | |
| other | Abdominal pain | Gastrointestinal disorders | Etoposide | 4 | 12 |
1 to 10 of 316Source ClinicalTrials.gov
See all 316 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Erlotinib | ||
| Total, all-cause mortality | Etoposide | ||
| Total, other adverse events | Erlotinib | 13 | 13 |
| Total, other adverse events | Etoposide | 11 | 12 |
| Total, serious adverse events | Erlotinib | 6 | 13 |
| Total, serious adverse events | Etoposide | 5 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Erlotinib vs Etoposide: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01032070/results?page=2