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Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Recurrent or Refractory Pediatric Ependymoma

Intervention: erlotinib (Drug); etoposide (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: OSI Pharmaceuticals

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Astellas Pharma Global Development

Summary

This is a phase 2 study to evaluate the efficacy of single-agent erlotinib versus oral etoposide in patients with recurrent or refractory pediatric ependymoma.

Clinical Details

Official title: A Randomized, Phase 2 Study of Single-agent Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants With an Objective Response

Secondary outcome:

Duration of Response

Percentage of Participants With a Minor Response

Percentage of Participants With Disease Control

Progression Free Survival (PFS)

Percentage of Participants With Prolonged Stable Disease

Duration of Stable Disease

Overall Survival (OS)

Safety Assessed Through Evaluation of Physical Exams, Vital Signs, Clinical Laboratory Tests and Adverse Events (AEs)

Area Under the Curve From Time 0 to 24 Hours Post-dose for Erlotinib

Maximum Observed Plasma Concentration of Erlotinib (Cmax)

Time to Maximum Observed Plasma Concentration of Erlotinib (Tmax)

Apparent Body Clearance (CL/F) of Erlotinib

Apparent Volume of Distribution (Vz/F) of Erlotinib

Detailed description: This is a phase 2 study involving a 1: 1 randomization of 40 patients with recurrent or refractory pediatric ependymoma who will receive either erlotinib or oral etoposide.

Eligibility

Minimum age: 1 Year. Maximum age: 21 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Recurrent of refractory ependymoma or subependymoma

- Performance Status (PS): Lansky ≥ 50% for patients ≤ 10 years of age or Karnofsky ≥

50% for patients >10 years of age

- Measurable disease, defined as 1 measurable lesion that can be accurately measured in

2 planes that has not received radiation therapy within 12 weeks

- Recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or

radiotherapy

- ≥ 1 year to ≤ 21 years

- Serum creatinine for patients ≤ 5 years in age is ≤ 0. 8 mg/dL or Creatinine

Clearance/Glomerular Filtration Rate (GFR) ≥ 70 mL/min/m^2

- Serum creatinine for patients > 5 and ≤ 10 years in age is ≤ 1. 0 mg/dL or Creatinine

Clearance/GFR ≥ 70 mL/min/m^2

- Serum creatinine for patients > 10 and ≤ 15 years in age is ≤ 1. 2 mg/dL or Creatinine

Clearance/GFR ≥ 70 mL/min/m^2

- Serum creatinine for patients > 15 years in age is ≤ 1. 5 mg/dL or Creatinine

Clearance/GFR ≥ 70 mL/min/m^2

- Total bilirubin is ≤ 1. 5 x upper limit of normal for age

- Alanine aminotransferase (ALT) ≤ 3 x upper limit of normal

- Absolute neutrophil count > 1000/µL

- Platelet count > 100,000/µL

- Hemoglobin > 8 gm/dL

- Neurologically stable for at least 7 days prior to randomization

- If receiving corticosteroids, patients must be on a stable or decreasing dose for at

least 7 days before randomization

- Patients of reproductive potential must agree to proactive effective contraceptive

measures for the duration of the study and for at least 90 days after completion of study drug Exclusion Criteria:

- Previously received epidermal growth factor receptor (EGFR)-targeted therapy

- Previously received oral etoposide

- Received craniospinal radiotherapy within 24 weeks prior to randomization

- Received field radiotherapy to the target lesion within 12 weeks prior to

randomization

- Received symptomatic metastatic disease within 14 days prior to randomization

- Received myelosuppressive chemotherapy within 21 days before randomization

- Received growth factors within 7 days prior to randomization

- Participating in another investigational drug trial

- Received a biologic agent within 7 days prior to randomization

- Received a monoclonal antibody within 28 days prior to randomization

- Taking cytochrome P450 (CYP)3A4 or CYP1A2 inhibitors/inducers within 14 days prior to

randomization

- Taking proton pump inhibitors within 14 days prior to randomization

- Smoking during treatment

- Pregnant or breast-feeding females

Locations and Contacts

Birmingham Children's Hospital, Birmingham B4 6NH, United Kingdom

Royal Hospital for Sick Children, Glasgow G3 8SJ, United Kingdom

Paediatric Oncology and Haematology Offices, Leeds LS1 3EX, United Kingdom

Alder Hey Children's NHS Foundation Trust Department of Oncology, Liverpool L12 1AP, United Kingdom

Royal Manchester Children's Hospital Ward 84, Manchester M13 9W2, United Kingdom

University of Nottingham Children's Brain Tumour Research Centre, Nottingham NG7 2UH, United Kingdom

Royal Marsden Hospital, Sutton SM2 5PT, United Kingdom

University of Alabama at Birmingham Dept. of Pediatric-Hematology/Oncology, Birmingham, Alabama 35233, United States

Strollery Children's Hospital Division of Hematology/Oncology, Edmonton, Alberta T6G 2B7, Canada

Center for Cancer and Blood Disorders-Phoenix Children's Hospital, Phoenix, Arizona 85016, United States

Children's and Women's Health Center of BC Division of Hematology/ Oncology/ BMT, Vancouver, British Columbia V6H 3V4, Canada

Children's Hospital of Orange County (CHOC), Orange, California 92868, United States

Stanford University and Lucile Packard Children's Hospital, Palo Alto, California 94304, United States

Children's Hospital Center for Cancer and Blood Disorders, Aurora, Colorado 80045, United States

Children's National Medical Center - D.C. Center for Cancer and Blood Disorders, Washington, District of Columbia 20010, United States

University of Miami, Miami, Florida 33136, United States

Emory University Children's Healthcare of Atlanta Aflac Cancer Center & Blood Disorders, Atlanta, Georgia 30322, United States

Johns Hopkins University School of Medicine, Baltimore, Maryland 21287, United States

Dana-Farber Cancer Institute Department of Pediatric Neuro-oncology, Boston, Massachusetts 02115, United States

Amplatz Children's Hospital University of Minnesota Medical Center- Pediatric Hematology Oncology, Minneapolis, Minnesota 55455, United States

Columbia University Children's Hospital of New York Presbyterian Child & Adolescent Oncology Center, New York, New York 10032, United States

Steven D Hassenfeld Children's Center - New York University, New York, New York 10016, United States

Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada

Oregon Health & Sciences University Doembecher Children's Hospital, Portland, Oregon 97124, United States

Penn State Hershey Children's Hospital, Hershey, Pennsylvania 17110, United States

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania 15224, United States

Children's Medical Center, Dallas Center for Cancer and Blood Disorders, Dallas, Texas 75235, United States

University of Wisconsin Pediatric Hematology/Oncology Department, Madison, Wisconsin 53705-2275, United States

Additional Information

Link to results on EudraCT

Starting date: September 2010
Last updated: June 12, 2015

Page last updated: August 23, 2015

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