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 11, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 23, 2010

Last Updated Date

December 11, 2012

Start Date ^ICMJE

April 2011

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT01247922 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Best disease response at end of treatment with erlotinib as determined by investigator [ Time Frame: An average of 4 months ] [ Designated as safety issue: No ]
Median treatment duration for patients receiving erlotinib in this clinical setting [ Time Frame: An average of 4 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Open-label, Phase 2 Study of Single-agent Erlotinib for Patients With Pediatric Ependymoma Previously Treated With Oral Etoposide in Protocol OSI-774-205

Brief Summary

Patients 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 will be allowed to participate in this study to assess the safety profile of single-agent erlotinib in patients with recurrent or refractory pediatric ependymoma.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Ependymoma

Intervention ^ICMJE

Drug: Erlotinib

continuous oral Erlotinib 85 mg/m2/day

Other Names:

Tarceva
OSI-774

Study Arm (s)

Experimental: Erlotinib

Patients will receive erlotinib on a 28-day treatment cycle

Intervention: Drug: Erlotinib

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

September 2012

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Year to 21 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01247922

Other Study ID Numbers ^ICMJE

OSI-774-206, 2010-023478-38

Has Data Monitoring Committee

Yes

Responsible Party

Astellas Pharma Inc ( OSI Pharmaceuticals )

Study Sponsor ^ICMJE

OSI Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Astellas Pharma Global Development

Information Provided By

Astellas Pharma Inc

Verification Date

December 2012

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

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