Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Laromustine + Cytarabine in Elderly AML/MDS
NCT00655395Phase 2
Key facts
- Status
- Terminated
- Start
- Mar 2008
- Primary completion
- Apr 2010
- Countries
- 1
- Sponsor
- Viron Therapeutics
- Modality
- Prodrugs/Conditional Activator Small Molecules
- Drugs
- laromustine
- Conditions
- acute myeloid leukemia (AML)myelodysplastic syndrome (MDS)
01
Overview
Phase 2, open-label trial of laromustine in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) (5 arms), sponsored by Viron Therapeutics. Primary endpoints: Safety and Efficacy and Overall Response Rate. Started Mar 2008; status: terminated.
02
Design
5 arms- Study design
- Non-randomizedOpen-label
Cohort 1
Laromustine 300 mg/m2 + Cytarabine
Cohort 2
Laromustine 400 mg/m2 + Cytarabine
Cohort 3
Laromustine 500 mg/m2 + Cytarabine
Cohort 4
Laromustine 600 mg/m2 + Cytarabine
Phase II Dose
Laromustine at recommended dose + Cytarabine
03
Who it enrols
Elderly patients (>=60 years) with AML or high-risk MDS, ECOG 0-2, and adequate organ function. Excludes active infection, severe heart/lung disease, and APL.
04
Endpoints
Primary
Safety and Efficacy
Overall Response Rate
Secondary
Toxicities
Beyond the preview
Go deeper on NCT00655395.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00655395.