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Trial intelligence / Profile preview
Temozolomide and Lapatinib for Recurrent Ependymoma
NCT00826241Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2009
- Primary completion
- Jul 2018
- Countries
- 1
- Sponsor
- National Institutes of Health
- Modality
- Small Molecules
- Drugs
- lapatinib
- Conditions
- ependymoma
01
Overview
Phase 2, open-label, single-arm trial of lapatinib in ependymoma, sponsored by National Institutes of Health. Primary endpoint: Time to Progression up to 4 years. Started Jan 2009; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Temozolomide + Lapatinib
Temozolomide 125-150 mg/m^2 days 1-7 & 15-21 + Lapatinib 1250 mg daily
03
Who it enrols
Adult patients with histologically proven recurrent ependymoma or anaplastic ependymoma, KPS >= 70, and adequate organ function. Excludes patients with recent cardiac events, HIV, or those taking CYP3A4 inducers/inhibitors.
04
Endpoints
Primary
Time to Progression
Secondary
Overall Response Rate
Adverse Events
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