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Spots Global Cancer Trial Database for Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205

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Trial Identification

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

Conditions

Ependymoma

Interventions

Erlotinib

Study Description

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.

Eligibility

Minimum Age: 1 Year

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Medical Monitor

Affiliation: Astellas Pharma Global Development

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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