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View Clinical Trial (Medical Research Study)
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A Safety and Dose-finding Study of JNJ-26481585 for Patients With Advanced of Refractory Leukemia or Myelodysplastic Syndrome. - NCT00676728- (Clinical Trial 220221)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy220221.aspx
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| City: |
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Houston |
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State:
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TX |
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| Conditions: |
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Leukemia, Myeloid, Acute - Precursor Cell Lymphoblastic Leukemia-Lymphoma - Leukemia, Myelogenous, Chronic, BCR-ABL Positive - Myelodysplastic Syndromes - Leukemia, Lymphocytic, Chronic, B-Cell |
| Purpose: |
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The purpose of this study is to assess JNJ-26481585 (a drug in development for cancer) the
safety in patients with advanced or refractory leukemia or myelodysplastic syndrome and the
maximum dose that can be tolerated by these patients. Absorption, breakdown and elimination
of the drug will be studied as well as the antitumor activity of JNJ-26481585 will be
assessed.
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| Study summary: |
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JNJ-26481585, a histone deacetylase (HDAC) inhibitor, is a new drug in development for
cancer. This research study is being carried out to determine what is the highest dose of
JNJ-26481585 that patients with advanced or refractory leukemia or myelodysplastic syndrome
can tolerate. The study will also test the safety (the effect on the body) of JNJ-26481585.
JNJ-26481585 will be administered in a continuous regimen with 21-day treatment cycles. The
dose of JNJ-26481585 will start low and will be increased during the study in groups of 2 to
6 patients. The dose each patient receives at study entry may be increased if deemed safe
and desirable to optimize potential antitumor activity. If a group of patients does not have
severe side effects, the next group of patients will get a higher dose. The dose will
increase until some patients have severe side effects. The dose will then be decreased to a
dose level where severe side effects are observed in less than 1/3 of patients. Once a safe
dose level has been determined an additional group of 16 patients will be treated. The
amount of JNJ-26481585 in the blood will be measured and the effect on the disease will be
evaluated in all patients. Patients will be screened for eligibility within 4 weeks before
study treatment is given. The treatment will consist of 21-day treatment cycles in a
continuous once daily dosing regimen. The duration of treatment will depend on adverse
effects and whether there is benefit from the treatment. The design of a cycle may be
adjusted during the course of the study to include days when there is no treatment (a pause)
as guided by clinical observations. Patients will be informed if there are changes in the
design of a cycle. During the first treatment cycle, patients are required to stay in the
hospital for 2 or 3 nights. In addition there are 8 daytime visits during Cycles 1 and 2
(combined) that may take up to 12 hours after the morning dose at 2 occasions and up to 4
hours after the morning dose at the other 6 occasions. From Cycle 3 onwards, there is only 1
daytime visit per treatment cycle, and these visits usually take up less time. Throughout
the study, especially during Cycles 1 and 2, patients will undergo frequent blood and urine
tests, procedures to assess safety including heart function, and tests to assess the course
of the patient's illness. Two weeks after the last dose of the study drug, patients are
required to return to the study site for follow-up assessments. JNJ-26481585 will be
provided as capsules and will be taken by mouth once daily throughout treatment. The dose
received by an individual patient will be determined at the time of enrollment.
Modifications to the treatment schedule or dosing regimen may be explored during the course
of this study. Patients can continue receiving treatment as long as there is benefit as
evaluated by the study doctor and there are no unacceptable side effects. |
| Criteria: |
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Inclusion Criteria:
- Confirmed advanced or refractory acute myeloid leukemia, acute lymphocytic leukemia,
chronic myeloid leukemia in blast phase, refractory chronic lymphocytic leukemia,
myelodysplastic syndrome, or chronic myelomonocytic leukemia
- Eastern Cooperative Oncology Group Performance Status Score <=2
- Adequate heart function (Left Ventricular Ejection Fraction >= 50%)
- Negative hepatitis B, C and human immunodeficiency virus (HIV) test within last 3
months
- Adequate liver and kidney function.
Exclusion Criteria:
- Known or suspected involvement of the central nervous system
- Chemotherapy (nitrosoureas and mitomycin C within 6 weeks), radiotherapy,
immunotherapy or treatment with investigative agent within 3 weeks before study drug
administration (except hydroxyurea which should be stopped at least 24 hours prior to
first dose)
- History of uncontrolled heart disease or uncontrolled hypertension (protocol-defined)
- Receiving medications known to have a risk of causing heart function abnormalities
(i.e.
- QTc prolongation and Torsades de Pointes)
- Neuropathy (malfunction of the nerves) > Grade 1 at baseline, uncontrolled
intercurrent illness. |
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| Study is available at: |
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Houston, TX
United States
Primary Contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email: info1@veritasmedicine.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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