A Phase I Study to Determine the Safety, Pharmacology, and Pharmacodynamics of JNJ26854165 in Subjects With Advanced Stage and/or Refractory Solid Tumors
JNJ-26854165 is a new drug in development and belongs to a class of drugs that act on the
specific protein present in cells. It may stop cancer cells from growing or kill cancer
cells. In this study, the safety (the effect on the body) of the JNJ-26854165 in patients
with advanced or refractory solid tumors will be examined. The effect (if any) of
JNJ-26854165 on the disease will be assessed throughout the study. The maximum dose
tolerated by these patients will be determined.
The dose of JNJ 26854165 will start low and will be increased during the study. The drug
will be taken by mouth every day in each 21-day cycle. The dose each patient receives will
be assigned at enrollment. Patients who enroll at a later time may receive a higher dose. If
patients do not have severe side effects at a certain dose level, the next group of 3 to 6
patients will get a higher dose. The dose will increase until some patients have severe side
effects. The dose will be then decreased and 3 to 6 patients will receive the highest amount
of drug where non-severe side effects were observed.
The amount of JNJ 26854165 in the blood will be measured and the effect of JNJ 26854165 on
the disease will also be monitored. The effect of food on the absorption, break down and
elimination of the drug will be studied in some patients. At some dose levels, the possible
interaction of JNJ 26854165 with medications frequently used in cancer patients will be
examined and patients at these dose levels will be asked to take a single dose of three
additional drugs (dextromethorphan hydrobromide (30mg), tolbutamide (250mg), and midazolam
(5mg) "cocktail") on 2 study days, which will all be supplied by the study doctor.
Patients will be screened for eligibility up to 4 weeks before the study drug is
administered. During Cycle 1 patients will be observed as inpatients for at least 12 hours
after administration of the drug on 3 or 4 days and will be required to visit the study site
on 2 additional days. One additional visit is required for patients in whom the food effect
or interaction with other medications will be examined. During Cycle 2, patients are
required to visit the study center on 2 days. During all cycles after Cycle 2, patients are
required to visit the study center on 1 day. Fourteen days after the last dose of
JNJ-26854165, the patient will be invited for a follow-up visit which will include tests for
safety and the effect of the drug on the disease. The proposed starting dose of JNJ-26854165
is 4 mg/day as a single oral dose. JNJ26854165 will be provided in a glass vial with
tear-off cap placed in a child resistant pouch so that the drug may be taken at home.
Patients will take JNJ-26854165 each day while in the study. Treatment may continue as long
as there is benefit and there are no unacceptable side effects as assessed by the study
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the safety of JNJ-26854165 and the maximum tolerated dose in patients with advanced stage or refractory solid tumors.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Institutional Review Board