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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
OSI Pharmaceuticals
Study ID
NCT01247922
Phase
PHASE2
Status
Terminated

Conditions

  • Ependymoma

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    continuous oral Erlotinib 85 mg/m\^2 per day

Study Details

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.

Key Dates

First listed
Nov 25, 2010
Start date
May 23, 2011
Status verified
Nov 2024
Primary completion
Sep 13, 2012
Completion
Sep 13, 2012

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

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) ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
Children's Hospital of Orange County (CHOC)OrangeCalifornia92868-
Packard Children's HospitalPalo AltoCalifornia94304-
The Children's Hospital Center for Cancer and Blood DisordersAuroraColorado80045-
Children's National Medical Center -D.C. Center for Cancer and Blood DisordersWashington D.C.District of Columbia20010-
University of MiamiMiamiFlorida33136-
Emory University Children's Healthcare of AtlantaAtlantaGeorgia30322-
University of Minnesota - Amplatz Children's HospitalMinneapolisMinnesota55455-
Oregon Health & Sciences University Doernbecher Children's HospitalPortlandOregon97124-
Childrens Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224-
University of WisconsinMadisonWisconsin53705-2275-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALChildren's Hospital of Orange County (CHOC)· Orange, CAPackard Children's Hospital· Palo Alto, CAThe Children's Hospital Center for Cancer and Blood Disorders· Aurora, COChildren's National Medical Center -D.C. Center for Cancer and Blood Disorders· Washington D.C., DCUniversity of Miami· Miami, FL

Related Studies