Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023478-38 | EudraCT Number |
Not provided
Not provided
Not provided
In a pre-planned interim analysis, OSI-774-205 met futility for efficacy with no safety concerns. As a result, the companion trial, OSI-774-206 has been stopped
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants that were assigned to the oral etoposide treatment arm in protocol OSI-774-205 and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide were allowed to participate in this study to assess the safety profile of single-agent erlotinib in participants with recurrent or refractory pediatric ependymoma.
The protocol-specified futility criteria were met at the second interim analysis dated 15 Aug 2012 for OSI-774-205. Per the Data Monitoring Committee's recommendation and FDA's agreement, the enrollment of patients in that study and Study OSI-774-206 was permanently closed.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental | Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | continuous oral Erlotinib 85 mg/m^2 per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs) | Safety is monitored through AEs, which includes abnormal or clinically significant vital sign assessments, laboratory test, physical examination findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention. A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the study drug. An AE was considered serious (SAE) if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events. | From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response | Best overall response was derived from an integrated clinical assessment by the study investigator as per institutional standards. This included radiographic assessments deemed appropriate by the investigator in the normal care of the patient. A determination of best overall response at the end of study treatment (complete response, partial response, minor response or stable disease) was only made if (1) any disease-related neurologic symptoms were stable or improving over the interval of the radiographic assessment and (2) corticosteroid dosing for the control of tumor-related signs/symptoms was stable or decreasing.If the investigator deems that a radiographic assessment is not needed, then evidence of clinical improvement may be used to determine best response provided that corticosteroid dosing for tumor-related signs/symptoms is stable or decreasing. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Children's Hospital of Orange County (CHOC) |
Not provided
| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results website | View source |
Not provided
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/.
Not provided
Not provided
Not provided
Not provided
Participants who consented to enter this OSI-774-206 study and fulfilled all the eligibility criteria (no more than 14 days prior to registration) were enrolled in this study no more than 21 days from the last dose of oral etoposide in Study OSI-774-205.
Participants recruited for this OSI-774-206 study were participants with pediatric ependymoma previously treated with oral etoposide in Study OSI-774-205 who progressed while on study or discontinued due to unacceptable toxicity.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| End of treatment (The mean treatment duration was 170.5 days.) |
| Median Treatment Duration | From first dose of study drug up to last dose of study drug (The mean treatment duration was 170.5 days) |
| Orange |
| California |
| 92868 |
| United States |
| Packard Children's Hospital | Palo Alto | California | 94304 | United States |
| The 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 | Atlanta | Georgia | 30322 | United States |
| University of Minnesota - Amplatz Children's Hospital | Minneapolis | Minnesota | 55455 | United States |
| Oregon Health & Sciences University Doernbecher Children's Hospital | Portland | Oregon | 97124 | United States |
| Childrens Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| University of Wisconsin | Madison | Wisconsin | 53705-2275 | United States |
| Stollery Children's Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| Children's and Women's Health Center of BC | Vancouver | British Columbia | V6H 3V4 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Birmingham Children's Hospital Oncology Department | 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 | Liverpool | L12 1AP | United Kingdom |
| Royal Manchester Children's Hospital Ward 84 | Manchester | M13 9W2 | United Kingdom |
| University of Nottingham | Nottingham | NG7 2UH | United Kingdom |
| Royal Marsden Hospital | Sutton | SM2 5pt | United Kingdom |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| 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 | Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs) | Safety is monitored through AEs, which includes abnormal or clinically significant vital sign assessments, laboratory test, physical examination findings associated with signs and/or symptoms requiring withdrawal, dose modification or medical intervention. A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the study drug. An AE was considered serious (SAE) if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events. | The analysis population is the Safety Analysis Set (SAF) consisted of all enrolled patients who received at least 1 dose of study drug. | Posted | Number | participants | From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Response | Best overall response was derived from an integrated clinical assessment by the study investigator as per institutional standards. This included radiographic assessments deemed appropriate by the investigator in the normal care of the patient. A determination of best overall response at the end of study treatment (complete response, partial response, minor response or stable disease) was only made if (1) any disease-related neurologic symptoms were stable or improving over the interval of the radiographic assessment and (2) corticosteroid dosing for the control of tumor-related signs/symptoms was stable or decreasing.If the investigator deems that a radiographic assessment is not needed, then evidence of clinical improvement may be used to determine best response provided that corticosteroid dosing for tumor-related signs/symptoms is stable or decreasing. | SAF | Posted | Number | participants | End of treatment (The mean treatment duration was 170.5 days.) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Median Treatment Duration | SAF | Posted | Median | Full Range | days | From first dose of study drug up to last dose of study drug (The mean treatment duration was 170.5 days) |
|
|
|
From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days.)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erlotinib | Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred. | 2 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Convulsion | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Brain death | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral coldness | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 13.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Skin striae | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Posture abnormal | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 13.0 | 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 for review and comment. Sponsor may delay the publication for an additional to 60 days to seek patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Medical Director | Astellas Pharma Global Development, Inc. | Astellas.resultsdisclosure@astellas.com |
| ID | Term |
|---|---|
| D004806 | Ependymoma |
| C531673 | Familial ependymoma |
| ID | Term |
|---|---|
| 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 |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Discontinued study due to treatment-related AEs |
|
| Died on treatment or within 30 days |
|
|
| Denominators |
|---|
| Categories |
|---|
|