Study Stopped
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
Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205
Open-label Phase 2 Study of Single-agent Erlotinib for Patients With Pediatric Ependymoma Previously Treated With Oral Etoposide in Protocol OSI-774-205
2 other identifiers
interventional
4
3 countries
21
Brief Summary
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.
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 May 2011
Shorter than P25 for phase_2
21 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
November 23, 2010
CompletedFirst Posted
Study publicly available on registry
November 25, 2010
CompletedStudy Start
First participant enrolled
May 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2012
CompletedResults Posted
Study results publicly available
January 11, 2016
CompletedDecember 6, 2024
November 1, 2024
1.3 years
November 23, 2010
October 26, 2015
November 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (2)
Best Overall Response
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)
Study Arms (1)
Erlotinib
EXPERIMENTALParticipants who received erlotinib in a continuous oral dose of 85 mg/m\^2 per day until dose modification, interruption or study discontinuation occurred.
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have been enrolled in OSI-774-205, been randomized to oral etoposide and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide
- Performance status: Lansky ≥ 50% for patients ≤ 10 years of age or younger or Karnofsky ≥ 50% for patients greater than 10 years of age
- Patients must have recovered from any acute toxicity to any prior anti-cancer treatment
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, serum glutamic pyruvic transaminase (SGPT) ALT ≤ 3 x ULN
- Serum creatinine based on age OR Creatinine Clearance/Glomerular Filtration Rate (GFR) ≥ 70 mL/min/m2
- Patients must be neurologically stable for at least 7 days before registration
- Patients, both males and females, with reproductive potential must agree to practice effective contraceptive measures for the duration of study drug therapy and for at least 90 days after completion of study drug therapy
- Patients must be able to take erlotinib orally
You may not qualify if:
- Taking strong/moderate CYP3A4 or CYP1A2 inhibitors/inducers ≤ 14 days before registration
- Have received any other chemotherapy or immunotherapy to treat ependymoma after discontinuation from OSI-774-205
- Taking proton pump inhibitors ≤ 14 days before registration
- Participating in another investigational drug trial while on study
- Pregnant or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Children's Hospital of Orange County (CHOC)
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
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
- Sr. Medical Director
- 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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2010
First Posted
November 25, 2010
Study Start
May 23, 2011
Primary Completion
September 13, 2012
Study Completion
September 13, 2012
Last Updated
December 6, 2024
Results First Posted
January 11, 2016
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/.