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

This study has been terminated.
(In a pre-planned interim analysis, OSI-774-205 met futility for efficacy with no safety concerns. As a result, the companion trial, OSI-774-206 has been stopped)
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01247922
First received: November 23, 2010
Last updated: December 7, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Ependymoma
Drug: Erlotinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs) [ Time Frame: From first dose of study drug to 30 days after last dose of study drug (The mean treatment duration was 170.5 days) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Best Overall Response [ Time Frame: End of treatment (The mean treatment duration was 170.5 days.) ] [ Designated as safety issue: No ]
    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.

  • Median Treatment Duration [ Time Frame: From first dose of study drug up to last dose of study drug (The mean treatment duration was 170.5 days) ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: May 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Erlotinib
continuous oral Erlotinib 85 mg/m^2 per day
Other Names:
  • Tarceva
  • OSI-774

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

Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247922

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
Children's Hospital of Orange County (CHOC)
Orange, California, United States, 92868
Packard Children's Hospital
Palo Alto, California, United States, 94304
United States, Colorado
The Children's Hospital Center for Cancer and Blood Disorders
Aurora, Colorado, United States, 80045
United States, District of Columbia
Children's National Medical Center -D.C. Center for Cancer and Blood Disorders
Washington, District of Columbia, United States, 20010
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory University Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
United States, Minnesota
University of Minnesota - Amplatz Children's Hospital
Minneapolis, Minnesota, United States, 55455
United States, Oregon
Oregon Health & Sciences University Doernbecher Children's Hospital
Portland, Oregon, United States, 97124
United States, Pennsylvania
Childrens Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53705-2275
Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Children's and Women's Health Center of BC
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
United Kingdom
Birmingham Children's Hospital Oncology Department
Birmingham, United Kingdom, B4 6NH
Royal Hospital for Sick Children
Glasgow, United Kingdom, G3 8SJ
Paediatric Oncology and Haematology Offices,
Leeds, United Kingdom, LS1 3EX
Alder Hey Children's NHS Foundation Trust
Liverpool, United Kingdom, L12 1AP
Royal Manchester Children's Hospital Ward 84
Manchester, United Kingdom, M13 9W2
University of Nottingham
Nottingham, United Kingdom, NG7 2UH
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5pt
Sponsors and Collaborators
OSI Pharmaceuticals
Investigators
Study Director: Medical Monitor Astellas Pharma Global Development
  More Information

Additional Information:
Responsible Party: OSI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01247922     History of Changes
Other Study ID Numbers: OSI-774-206  2010-023478-38 
Study First Received: November 23, 2010
Results First Received: October 26, 2015
Last Updated: December 7, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Pediatric Ependymoma
Ependymoma
Erlotinib
Tarceva

Additional relevant MeSH terms:
Ependymoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Erlotinib Hydrochloride
Etoposide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on December 02, 2016