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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01247922
Other study ID # OSI-774-206
Secondary ID 2010-023478-38
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 23, 2011
Est. completion date September 13, 2012

Study information

Verified date June 2019
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date September 13, 2012
Est. primary completion date September 13, 2012
Accepts healthy volunteers No
Gender All
Age group 1 Year to 21 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Erlotinib
continuous oral Erlotinib 85 mg/m^2 per day

Locations

Country Name City State
Canada Stollery Children's Hospital Edmonton Alberta
Canada Hospital for Sick Children Toronto Ontario
Canada Children's and Women's Health Center of BC Vancouver British Columbia
United Kingdom 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 States Emory University Children's Healthcare of Atlanta Atlanta Georgia
United States The Children's Hospital Center for Cancer and Blood Disorders Aurora Colorado
United States University of Alabama at Birmingham Birmingham Alabama
United States University of Wisconsin Madison Wisconsin
United States University of Miami Miami Florida
United States University of Minnesota - Amplatz Children's Hospital Minneapolis Minnesota
United States Children's Hospital of Orange County (CHOC) Orange California
United States Packard Children's Hospital Palo Alto California
United States Childrens Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania
United States Oregon Health & Sciences University Doernbecher Children's Hospital Portland Oregon
United States Children's National Medical Center -D.C. Center for Cancer and Blood Disorders Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
OSI Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Best Overall Response Best overall response was derived from an integrated clinical assessment by the study investigator as per institutional standards. This included radiographic assessments deemed appropriate by the investigator in the normal care of the patient. A determination of best overall response at the end of study treatment (complete response, partial response, minor response or stable disease) was only made if (1) any disease-related neurologic symptoms were stable or improving over the interval of the radiographic assessment and (2) corticosteroid dosing for the control of tumor-related signs/symptoms was stable or decreasing.If the investigator deems that a radiographic assessment is not needed, then evidence of clinical improvement may be used to determine best response provided that corticosteroid dosing for tumor-related signs/symptoms is stable or decreasing. End of treatment (The mean treatment duration was 170.5 days.)
Secondary Median Treatment Duration From first dose of study drug up to last dose of study drug (The mean treatment duration was 170.5 days)
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