CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
sorafenib, vorinostat and bortezomibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01534260
NCT01534260Phase 2Completed
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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

Hamid Sayar·interventional·Posted Feb 16, 2012·Updated Aug 17, 2018

In Brief

A Phase 2 clinical trial evaluating sorafenib, vorinostat and bortezomib for Acute Myeloid Leukemia. Completed, enrolled 37 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesUnited States
CollaboratorsMillennium Pharmaceuticals, Inc., Bayer, Merck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 16, 2012
Enrollment StartFeb 10, 2012
Primary CompletionAug 29, 2016
Study CompletionFeb 13, 2017
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 14.4 years ago

Interventions

sorafenib, vorinostat and bortezomibdrug

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.