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Erlotinib Plus Bevacizumab in Advanced Thymoma and Thymic Carcinoma
NCT00369889Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2006
- Primary completion
- Sep 2007
- Countries
- 1
- Sponsor
- Indiana University School of Medicine
- Modality
- Small Molecules, Monoclonal Antibodies
- Drugs
- erlotinibbevacizumab
- Conditions
- thymomathymic carcinoma (TC)
01
Overview
Phase 2, open-label, single-arm trial of erlotinib and bevacizumab in thymoma and thymic carcinoma (TC), sponsored by Indiana University School of Medicine. Primary endpoint: Objective Response Rate. Started Aug 2006; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Erlotinib + Bevacizumab
Erlotinib 150 mg daily PO + Bevacizumab 15 mg/kg IV every 21 days
03
Who it enrols
Adult patients with histologically confirmed invasive, recurrent or metastatic thymoma or thymic carcinoma who have received prior chemotherapy and have measurable disease. Patients must have adequate organ function and no prior EGFR inhibitor or anti-angiogenic therapy.
04
Endpoints
Primary
Objective Response Rate
Secondary
Time to Progression
Toxicity
VEGF Expression
VEGF Gene Polymorphisms
Phosphorylated EGFR Expression
EGFR Expression by IHC and FISH
05
Results
Not all primary endpoints met
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