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Brief Title: Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205
Official Title: Open-label Phase 2 Study of Single-agent Erlotinib for Patients With Pediatric Ependymoma Previously Treated With Oral Etoposide in Protocol OSI-774-205
Study ID: NCT01247922
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.
Detailed Description: 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.
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Children's Hospital of Orange County (CHOC), Orange, California, United States
Packard Children's Hospital, Palo Alto, California, United States
The Children's Hospital Center for Cancer and Blood Disorders, Aurora, Colorado, United States
Children's National Medical Center -D.C. Center for Cancer and Blood Disorders, Washington, District of Columbia, United States
University of Miami, Miami, Florida, United States
Emory University Children's Healthcare of Atlanta, Atlanta, Georgia, United States
University of Minnesota - Amplatz Children's Hospital, Minneapolis, Minnesota, United States
Oregon Health & Sciences University Doernbecher Children's Hospital, Portland, Oregon, United States
Childrens Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
University of Wisconsin, Madison, Wisconsin, United States
Stollery Children's Hospital, Edmonton, Alberta, Canada
Children's and Women's Health Center of BC, Vancouver, British Columbia, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
Birmingham Children's Hospital Oncology Department, Birmingham, , United Kingdom
Royal Hospital for Sick Children, Glasgow, , United Kingdom
Paediatric Oncology and Haematology Offices,, Leeds, , United Kingdom
Alder Hey Children's NHS Foundation Trust, Liverpool, , United Kingdom
Royal Manchester Children's Hospital Ward 84, Manchester, , United Kingdom
University of Nottingham, Nottingham, , United Kingdom
Royal Marsden Hospital, Sutton, , United Kingdom
Name: Medical Monitor
Affiliation: Astellas Pharma Global Development
Role: STUDY_DIRECTOR