Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205
NCT ID: NCT01247922
Last Updated: 2024-12-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2011-05-23
2012-09-13
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Erlotinib
continuous oral Erlotinib 85 mg/m\^2 per day
Interventions
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Erlotinib
continuous oral Erlotinib 85 mg/m\^2 per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
1 Year
21 Years
ALL
No
Sponsors
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OSI Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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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 D.C., 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
Countries
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Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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2010-023478-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OSI-774-206
Identifier Type: -
Identifier Source: org_study_id