- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00875745
Combination of Sorafenib and Vorinostat in Poor-risk Acute Myelogenous Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)
September 17, 2014 updated by: Indiana University School of Medicine
Phase I, Open-label, Dose-escalation Study of the Combination of Sorafenib and Vorinostat in Poor-risk Acute Myelogenous Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS)
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Melvin and Bren Simon Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Baseline through cycle 3
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Evaluate response and the duration of response to this combination targeted therapy
Time Frame: Baseline through Cycle 3
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Baseline through Cycle 3
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Evaluate the toxicity of the combination of Sorafenib and Vorinostat in patients receiving this therapy
Time Frame: Baseline through Cycle 3
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Baseline through Cycle 3
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
April 2, 2009
First Submitted That Met QC Criteria
April 2, 2009
First Posted (Estimate)
April 3, 2009
Study Record Updates
Last Update Posted (Estimate)
September 18, 2014
Last Update Submitted That Met QC Criteria
September 17, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Syndrome
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Preleukemia
- Leukemia, Promyelocytic, Acute
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Histone Deacetylase Inhibitors
- Sorafenib
- Vorinostat
Other Study ID Numbers
- 0902-08; IUCRO-0234
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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