Back to resultsSingle-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205
Primary Purpose
Ependymoma
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Erlotinib
Sponsored by
About this trial
This is an interventional treatment trial for Ependymoma focused on measuring Pediatric Ependymoma, Ependymoma, Tarceva, Erlotinib
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham
- Children's Hospital of Orange County (CHOC)
- Packard Children's Hospital
- The Children's Hospital Center for Cancer and Blood Disorders
- Children's National Medical Center -D.C. Center for Cancer and Blood Disorders
- University of Miami
- Emory University Children's Healthcare of Atlanta
- University of Minnesota - Amplatz Children's Hospital
- Oregon Health & Sciences University Doernbecher Children's Hospital
- Childrens Hospital of Pittsburgh of UPMC
- University of Wisconsin
- Stollery Children's Hospital
- Children's and Women's Health Center of BC
- Hospital for Sick Children
- Birmingham Children's Hospital Oncology Department
- Royal Hospital for Sick Children
- Paediatric Oncology and Haematology Offices,
- Alder Hey Children's NHS Foundation Trust
- Royal Manchester Children's Hospital Ward 84
- University of Nottingham
- Royal Marsden Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Erlotinib
Arm Description
Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Median Treatment Duration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01247922
Brief Title
Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
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
Study Start Date
May 23, 2011 (Actual)
Primary Completion Date
September 13, 2012 (Actual)
Study Completion Date
September 13, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OSI Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ependymoma
Keywords
Pediatric Ependymoma, Ependymoma, Tarceva, Erlotinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erlotinib
Arm Type
Experimental
Arm Description
Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva, OSI-774
Intervention Description
continuous oral Erlotinib 85 mg/m^2 per day
Primary Outcome Measure Information:
Title
Safety Assessed Through Evaluation of Physical Examinations, Vital Signs, Clinical Laboratory Tests, and Adverse Events (AEs)
Description
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.
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)
Secondary Outcome Measure Information:
Title
Best Overall Response
Description
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.
Time Frame
End of treatment (The mean treatment duration was 170.5 days.)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Children's Hospital of Orange County (CHOC)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
The Children's Hospital Center for Cancer and Blood Disorders
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's National Medical Center -D.C. Center for Cancer and Blood Disorders
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Minnesota - Amplatz Children's Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Oregon Health & Sciences University Doernbecher Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97124
Country
United States
Facility Name
Childrens Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705-2275
Country
United States
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Children's and Women's Health Center of BC
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Birmingham Children's Hospital Oncology Department
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Glasgow
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Facility Name
Paediatric Oncology and Haematology Offices,
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Alder Hey Children's NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L12 1AP
Country
United Kingdom
Facility Name
Royal Manchester Children's Hospital Ward 84
City
Manchester
ZIP/Postal Code
M13 9W2
Country
United Kingdom
Facility Name
University of Nottingham
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5pt
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=329
Description
Link to results on Astellas Clinical Study Results website
Learn more about this trial
Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205
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