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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:
ClinicalTrials.gov Identifier:
NCT01247922
First Posted: November 25, 2010
Last Update Posted: January 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )
November 23, 2010
November 25, 2010
October 26, 2015
January 11, 2016
January 11, 2016
May 2011
September 2012   (Final data collection date for primary outcome measure)
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) ]
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.
Assess safety profile of single-agent erlotinib in patients with recurrent or refractory pediatric ependymoma previously treated with oral etoposide [ Time Frame: An average of 4 months ]
Complete list of historical versions of study NCT01247922 on ClinicalTrials.gov Archive Site
  • Best Overall Response [ Time Frame: End of treatment (The mean treatment duration was 170.5 days.) ]
    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) ]
  • Best disease response at end of treatment with erlotinib as determined by investigator [ Time Frame: An average of 4 months ]
  • Median treatment duration for patients receiving erlotinib in this clinical setting [ Time Frame: An average of 4 months ]
Not Provided
Not Provided
 
Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205
Open-label, Phase 2 Study of Single-agent Erlotinib for Patients With Pediatric Ependymoma Previously Treated With Oral Etoposide in Protocol OSI-774-205
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.
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ependymoma
Drug: Erlotinib
continuous oral Erlotinib 85 mg/m^2 per day
Other Names:
  • Tarceva
  • OSI-774
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.
Intervention: Drug: Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
September 2012
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
1 Year to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United Kingdom,   United States
 
 
NCT01247922
OSI-774-206
2010-023478-38 ( EudraCT Number )
Yes
Not Provided
Not Provided
Astellas Pharma Inc ( OSI Pharmaceuticals )
OSI Pharmaceuticals
Not Provided
Study Director: Medical Monitor Astellas Pharma Global Development
Astellas Pharma Inc
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP