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

November 23, 2010
December 11, 2012
April 2011
September 2012   (final data collection date for primary outcome measure)
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 ]
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: Yes ]
Complete list of historical versions of study NCT01247922 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ependymoma
Drug: Erlotinib
continuous oral Erlotinib 85 mg/m2/day
Other Names:
  • Tarceva
  • OSI-774
Experimental: Erlotinib
Patients will receive erlotinib on a 28-day treatment cycle
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
Both
1 Year to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   United Kingdom
 
NCT01247922
OSI-774-206, 2010-023478-38
Yes
Astellas Pharma Inc ( OSI Pharmaceuticals )
OSI Pharmaceuticals
Not Provided
Study Director: Medical Monitor Astellas Pharma Global Development
Astellas Pharma Inc
December 2012

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