Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205

Ependymoma Clinical Trial

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

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
• 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
• 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

Related Conditions & MeSH terms

• Ependymoma

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)

External Links

•   Link to results on Astellas Clinical Study Results website