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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

Phase 1
18 Years
Not Enrolling
Protein Kinase Inhibitors, Antineoplastic Protocols, Clinical Trial, Phase 1, Maximum Tolerated Dose, Pharmacokinetics, Advanced Malignancies, Solid Malignancies

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Trial Information

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

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

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.

Inclusion Criteria:

- Confirmed diagnosis of solid malignancy that is advanced or refractory and
progressing and for which standard treatments do not exist or are no longer effective

- radiological assessment of disease within 4 weeks of first study drug administration

- overall health status as determined by the Eastern Cooperative Oncology Group (ECOG)
< = 2

- life expectancy > 3 months

- adequate gastrointestinal absorption and ability to swallow

- left ventricular ejection fraction (LVEF) > 50% and protocol-defined criteria for
laboratory tests.

Exclusion Criteria:

- Cancer has spread to the central nervous system

- chemotherapy, radiotherapy, immunotherapy within 4 weeks before study drug
administration or incomplete recovery from preceding surgery or toxicity of prior
anticancer therapy (excluding peripheral neuropathy and alopecia)

- history of uncontrolled heart disease as defined in the protocol

- history of pulmonary fibrosis

- acute infection requiring systemic therapy.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the safety (effects on the body) and the maximum tolerated dose of JNJ-26483327 in patients with cancer. Determine how JNJ-26483327 taken by patients as an oral capsule is absorbed, broken down and eliminated.

Principal Investigator

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


United States: Institutional Review Board

Study ID:




Start Date:

August 2006

Completion Date:

July 2008

Related Keywords:

  • Protein Kinase Inhibitors
  • Antineoplastic Protocols
  • Clinical Trial, Phase 1
  • Maximum Tolerated Dose
  • Pharmacokinetics
  • Advanced Malignancies
  • Solid Malignancies
  • Advanced Solid Cancers
  • Refractory Solid Cancers
  • Protein Kinase Inhibitors
  • Phase 1 Study
  • Oral Chemotherapy
  • Neoplasms