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Erlotinib in Higher Risk Myelodysplastic Syndrome
NCT01085838Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2010
- Primary completion
- Mar 2014
- Countries
- 1
- Sponsor
- Groupe Français des Myélodysplasies
- Modality
- Small Molecules
- Drugs
- erlotinib
- Conditions
- myelodysplastic syndrome (MDS)
01
Overview
Phase 2, open-label trial of erlotinib in myelodysplastic syndrome (MDS) (3 cohorts), sponsored by Groupe Français des Myélodysplasies. Primary endpoint: Overall Response Rate at 12 weeks. Started Jul 2010; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
Cohort 1
Erlotinib 100 mg daily
Cohort 2
Erlotinib 150 mg daily
Cohort 3
Erlotinib 300 mg daily
03
Who it enrols
Patients with high-risk MDS (IPSS > 1) and 10-30% bone marrow blasts who are ineligible for or have failed intensive chemotherapy and hypomethylating agents.
04
Endpoints
Primary
Overall Response Rate
Secondary
Response Duration
Overall Survival
Treatment-related Toxicity
Correlation of Prognostic Parameters
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