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Date: 2010-08-18
Phase: III
Anouncement: Launch
Biotech: Clavis Pharma (Norway)
Pharma:
Product: Elacytarabine (lipid-conjugated derivative of cytarabine developed using Clavis' lipid vector technology) The has been granted orphan drug status for the treatment of acute myeloid leukemia in the US and EU.
Disease: acute myeloid leukemia
Country: USA and Europe
Other: Clavis Pharma has recruited the first patient into its pivotal Phase III study assessing its lead product elacytarabine in patients with late-stage acute myeloid leukemia (AML).
The Phase III study (known as the CLAVELA study) is an open-label, randomised trial comparing elacytarabine with the investigator's choice of treatment in patients with late-stage AML (i.e. those who have failed two or three previous treatment regimes).
The trial will recruit up to 350 patients at 65 sites in the USA and Europe.
Patients randomised to the investigators' choice group can receive a range of treatments including:
*High-dose cytarabine for up to six days
*MEC - mitoxantrone, etoposide and cytarabine
*FLAG or FLAG-IDA - fludarabine, cytarabine, G-CSF and idarubicin
*Low-dose cytarabine for up to two weeks
*Hypomethylating agents - azacytidine or decitabine
*Best supportive care .

The primary objective of the study is to compare overall survival between patients treated with elacytarabine and those treated with the investigator's choice.
The secondary objectives are to compare the response rates, duration of response, and safety profile of elacytarabine with the investigator's choice treatments.
In addition, the study aims to characterize the exposure-response relationships for elacytarabine as measures of effectiveness and toxicity.

Clavis Pharma expects to complete patient recruitment late in the second half of 2011 and to report in the second half of 2012.
The results from this study, if positive, will be used by Clavis Pharma to support regulatory filings in the USA and Europe.