A Safety and Dose-finding Study of JNJ-26481585 for Patients With Advanced Solid Malignancies and Lymphoma.
NCT ID: NCT00677105
Last Updated: 2012-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
92 participants
INTERVENTIONAL
2007-08-31
2011-09-30
Brief Summary
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Detailed Description
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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 will not increase, but patients who receive drug at a later enrollment time may receive a higher dose. 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 12-24 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. In some patients, the effect of food on the absorption, break down, and elimination of the study drug will also be studied.
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. The dosing regimen may be adjusted to twice daily or three times daily intake as guided by information on how rapidly your body breaks down and eliminates the study drug. Patients will be informed if there are changes in the design of a cycle or the dosing regimen.
During the first treatment cycle, patients are required to stay in the hospital for 3 or 4 nights. In addition there are 8 or 9 daytime visits during Cycles 1 and 2 (combined) that may take up to 12 hours after the morning dose at 2 or 3 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 patients 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 starting dose level will be 2 mg but 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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JNJ-26481585
Eligibility Criteria
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Inclusion Criteria
* Performance status (based on the Eastern Cooperative Oncology Group assessments) of \<= 2
* Life expectancy \> 3 months
* Adequate gastrointestinal absorption status
* Adequate liver, kidney and bone marrow function
* Adequate heart function (Left Ventricular Ejection Fraction \>= 50%)
Exclusion Criteria
* Chemotherapy (in the case of nitrosoureas and mitomycin C within 6 weeks), radiotherapy, immunotherapy or treatment with an investigational agent within 4 weeks before study drug administration
* History of uncontrolled heart disease or uncontrolled arterial hypertension (protocol-defined)
* Patients taking medications known to have a risk of causing heart function abnormalities (i.e.
* QTc prolongation and Torsades de Pointes)
* Neuropathy (malfunction of the nerves) at baseline of Grade \> = 2
* Positive serology for Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV)
18 Years
ALL
No
Sponsors
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Janssen Pharmaceutica N.V., Belgium
INDUSTRY
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Principal Investigators
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Locations
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Glasgow, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastel Upon Tyne, , United Kingdom
Sutton, , United Kingdom
Countries
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Other Identifiers
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CR013924
Identifier Type: -
Identifier Source: org_study_id