Pharmacokinetics Clinical Trial
Official title:
An Open-label, Phase I Study to Determine the Safety and Pharmacokinetics of JNJ-26483327, a Multi-targeted Kinase Inhibitor, Administered to Subjects With Advanced Stage and/or Refractory Solid Malignancies
The purpose of this study is to assess JNJ-26483327 (a drug in development for cancer) for the safety of the drug in patients with advanced solid tumors that have not responded or are no longer responding to available therapies. The absorption, breakdown and elimination of the drug will also be studied.
JNJ-26483327, a multi-targeted reversible kinase inhibitor, is a new drug in development for
treatment of cancer. This study will test the safety (the effect on the body) of
JNJ-26483327 and the highest dose of JNJ-26483327 that patients with advanced cancer can
tolerate will be determined. Antitumor activity of JNJ-26481585 will be evaluated.
JNJ-26483327 will be administered in a continuous regimen (orally twice daily) in 28-day
treatment cycles. The dose of JNJ-26483327 will start low and will be increased during the
study in groups of 1 to 6 patients. If a patient or 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 12-18 patients will be treated. The amount
of JNJ-26483327 in the blood will be measured and the effect of 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 28-day treatment cycles in a continuous twice daily dosing
regimen.
During Cycle 1, patients are required to stay in the hospital for 2-3 nights and 2 full
days. In addition there are 5 daytime visits during Cycles 1 and 2 (combined) that may take
up to 6 hours after the morning dose. From Cycle 3 onwards, one hospital visit is required
for each cycle of treatment.
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. The duration of treatment will depend on adverse
effects and whether there is benefit from the treatment. Two weeks after the last dose of
the study drug, patients are required to return to the study site for follow-up assessments.
Patients will take JNJ-26483327 capsules by mouth twice a day throughout treatment. Patients
will be allowed to continue at the same dose level as long as there are no unacceptable side
effects, and there is benefit to the patient based on the study doctor's evaluations.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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