Status and phase
Conditions
Treatments
About
The purpose of this study is to test the safety of sorafenib and vorinostat when given together to see what effects (good and bad) it has on the patient and their acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). This study is also being done to find the highest dose of sorafenib and vorinostat that can be given together without causing severe side effects.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patients must have a diagnosis of AML (> 20% myeloid blasts in the peripheral blood or bone marrow) or MDS with > 10% myeloid blasts in the bone marrow. Patients with Acute Promyelocytic Leukemia (APL) must be refractory to all-trans retinoic acid (ATRA) and arsenic trioxide.
The patients must have one of the following criteria:
The patient must have discontinued all previous therapies for acute leukemia for at least 14 days and recovered from the acute effects of the therapy.
Patients must have an ECOG (Zubrod) performance status of 0-2
Patients must be able to take and tolerate oral medications
Patients must have adequate organ function as specified in the protocol.
Patients not on anti-coagulation must have an INR < 1.5 and a PTT within normal limits.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
15 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal