Phase I/II Study of Combination of Sorafenib, Vorinostat, and Bortezomib for the Treatment of Acute Myeloid Leukemia With Complex- or Poor-risk (Monosomy 5/7) Cytogenetics or FLT3-ITD Positive Genotype

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

February 10, 2012

Primary Completion Date

August 29, 2016

Study Completion Date

February 13, 2017

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

sorafenib, vorinostat and bortezomib

Escalating dose cohorts of sorafenib, vorinostat and bortezomib. The first cohort will receive sorafenib from day 1 to 14, vorinostat will be given on days 1-4 and 8-12, and bortezomib will be given on days 1 and 8. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.

Trial Locations (1)

46202

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

collaborator

Bayer

INDUSTRY

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Hamid Sayar

OTHER