NCT01534260

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Hamid Sayar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being done because treatment options are very limited and usually unsuccessful for Acute Myeloid Leukemia (AML) in older individuals, or younger people with disease that has relapsed and/or proven resistant to standard therapy. Subjects are invited to participate in this study that will examine the use of three drugs called Sorafenib (Nexavar), Vorinostat (Zolinza) and Bortezomib (Velcade) for treating acute myeloid leukemia.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-02-10
• Primary completion: 2016-08-29
• Completion: 2017-02-13
• First posted: 2012-02-16
• Last updated: 2018-08-17
• Results posted: 2018-08-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study