Study 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.
Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma
PETEY
A Randomized, Phase 2 Study of Single-agent Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma
2 other identifiers
interventional
25
3 countries
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2010
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2009
CompletedFirst Posted
Study publicly available on registry
December 15, 2009
CompletedStudy Start
First participant enrolled
September 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2012
CompletedResults Posted
Study results publicly available
January 8, 2014
CompletedDecember 12, 2024
November 1, 2024
2.2 years
December 10, 2009
November 20, 2013
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (13)
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.
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.
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.
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.
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.
- +8 more secondary outcomes
Study Arms (2)
Erlotinib
EXPERIMENTALErlotinib 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 COMPARATOREtoposide 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +2 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
University of Alabama at Birmingham Dept. of Pediatric-Hematology/Oncology
Birmingham, Alabama, 35233, United States
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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.
Results Point of Contact
- Title
- Senior Medical Director, Medical Oncology
- Organization
- Astellas Pharma Global Development, Inc
Study Officials
- STUDY DIRECTOR
Medical Monitor
Astellas Pharma Global Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2009
First Posted
December 15, 2009
Study Start
September 27, 2010
Primary Completion
November 26, 2012
Study Completion
November 26, 2012
Last Updated
December 12, 2024
Results First Posted
January 8, 2014
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
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/.