Trials / Terminated
TerminatedNCT01247922
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- OSI Pharmaceuticals · Industry
- Sex
- All
- Age
- 1 Year – 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Erlotinib | continuous oral Erlotinib 85 mg/m\^2 per day |
Timeline
- Start date
- 2011-05-23
- Primary completion
- 2012-09-13
- Completion
- 2012-09-13
- First posted
- 2010-11-25
- Last updated
- 2024-12-06
- Results posted
- 2016-01-11
Locations
21 sites across 3 countries: United States, Canada, United Kingdom
Source: ClinicalTrials.gov record NCT01247922. Inclusion in this directory is not an endorsement.