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CompletedNCT00875745Updated Sep 18, 2014

Combination of Sorafenib and Vorinostat in Poor-risk Acute Myelogenous Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)

A Phase 1 interventional study of Sorafenib-Vorinostat in Leukemia, Myeloid, Acute, Leukemia, Promyelocytic, Acute and Myelodysplastic Syndromes, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-18.

Sponsored by Indiana University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Leukemia, Myeloid, Acute
  • Leukemia, Promyelocytic, Acute
  • Myelodysplastic Syndromes
03

In context

Leukemia, Myeloid, Acute

3,035 studies on the registry are indexed under Leukemia, Myeloid, Acute; 746 are open to participants now.

This study's enrollment of 15 is below the median of 40 across 2,561 interventional studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

Indiana University is the lead sponsor of 982 studies on the registry; 199 are open to participants now.

Of its 148 completed or terminated interventional studies of FDA-regulated products, 117 (79%) have results posted.

Browse Indiana University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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:

    • Age of 18 to 69 years; relapsed or refractory disease following at least one prior therapeutic regimen; not a candidate for cytotoxic or other conventional therapies due to disease refractoriness, poor performance status, or co-morbidities
    • Age of 70 years or older; received no previous therapies (other than hematopoietic growth factors or hydroxyurea); not a candidate for cytotoxic or other conventional therapies due to poor performance status, co-morbidities, or personal preference
    • Age of 70 years or older with relapsed or refractory disease
  • 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

Exclusion Criteria:

  • Pregnant women or nursing mothers are not eligible for this trial.
  • Patients may receive no other concurrent biologic therapy, cytotoxic chemotherapy or radiation therapy during this trial.
  • Patients with one or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study. See protocol for listing.
  • Patients with known central nervous system (CNS) leukemia by spinal fluid cytology, flow cytometry or imaging
  • Patients with previous autologous or allogeneic stem cell transplantation who have current side effects and/or complications that in the opinion of the investigator can interfere with the interpretation of the toxicities.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Sorafenib-Vorinostat

    This is a single-arm, non-randomized feasibility and safety Phase I trial of a combination of Sorafenib and Vorinostat, both administered orally.

    Drug: Sorafenib-Vorinostat

Interventions

  • DrugSorafenib-Vorinostat

    Patients will be entered in successive cohorts. The first cohort will receive Sorafenib at 400 mg bid (800 mg daily) and Vorinostat at 100 mg bid (200 mg daily).

    Also known as: Nexavar (Sorafenib), Zolinza (Vorinostat)

06

What researchers measure

Primary outcomes

  1. Determine the maximum tolerated dose of a combination of Sorafenib and Vorinostat administered to patients with poor-risk AML, or MDS with >10% blasts.

    Time frame: Baseline through cycle 3

Secondary outcomes

  1. Evaluate response and the duration of response to this combination targeted therapy

    Time frame: Baseline through Cycle 3

  2. Evaluate the toxicity of the combination of Sorafenib and Vorinostat in patients receiving this therapy

    Time frame: Baseline through Cycle 3

07

Study locations

1 site
  • Indiana University Melvin and Bren Simon Cancer Center
    Indianapolis, Indiana 46202, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2009, a primary completion of May 2010 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2009
First posted
Apr 3, 2009
Start
Apr 2009
Primary completionActual
May 2010
CompletionActual
Oct 2013
Last update
Sep 18, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00875745
Lead sponsor
Indiana University
Collaborators
Bayer
Responsible party
Sponsor
First posted
Apr 3, 2009
Start date
Apr 2009
Primary completion
May 2010
Completion
Oct 2013
Last update
Sep 18, 2014

Study contacts

Hamid Sayar, MD
principal investigator · Indiana University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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