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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Hamid Sayar
Study ID
NCT01534260
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • sorafenib, vorinostat and bortezomib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 10, 2012
Status verified
Jul 2018
Primary completion
Aug 29, 2016
Completion
Feb 13, 2017

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: sorafenib, vorinostat and bortezomib
    Escalating cohorts of sorafenib, vorinostat and bortezomib

Primary Outcome Measure

Number of Patients With Dose Limiting Toxicity [ Time Frame: up to 9 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-

Find similar trials in Indianapolis, IN

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Indiana University Melvin and Bren Simon Cancer Center· Indianapolis, IN

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