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A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of the Selective Met Inhibitor JNJ-38877605 in Subjects With Advanced or Refractory Solid Tumors

Phase 1
18 Years
Not Enrolling

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Trial Information

A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of the Selective Met Inhibitor JNJ-38877605 in Subjects With Advanced or Refractory Solid Tumors

JNJ-38877605 is a new drug being developed for the treatment of cancer. It is an inhibitor
of mesenchymal epithelial transition (Met) kinase, a substance identified in many cancers.
This is the first study in which JNJ-38877605 will be administered in man. This research
study is being carried out to determine the highest dose of JNJ-38877605 that patients with
advanced or refractory solid tumors can tolerate. The study will also test the safety of
JNJ-38877605. Safety evaluations will include an assessment of adverse events, clinical
laboratory data, electrocardiograms, vital signs measurements, physical examination
findings, and Eastern Oncology Cooperative Group (ECOG) performance status. In some patients
the effect of food on how the drug is absorbed will also be studied. Throughout the study,
treatment will be given in cycles which will be 21 days long and the study drug will be
taken once a day. The number of cycles will depend on the effects the drug has on the
patient and whether the patient benefits from the treatment. The design of a cycle may be
adjusted during the course of the study, so that the cycle is shorter or longer, or includes
some days when the patient does not receive treatment (a pause = intermittent treatment). It
is also possible the drug will be taken more than once a day. In case of any changes to the
drug administration schedule, the schedule and the timing of visits and blood/urine tests
may be adapted accordingly, without increasing their number. During the first treatment
cycle, 2 or 3 overnight stays in the hospital are required and visits to the hospital during
cycles 1, 2, 3, and 4 may take up to 12 hours after the morning dose. From cycle 5 onwards,
there is a daytime visit only once every cycle, and these usually take up less time.
Patients are informed about the current visit schedule at enrollment and throughout the
study. The dose of JNJ-38877605 administered in the study will start low and will be
increased during the study. The amount of study drug taken each day by an individual patient
depends on when the patient enrolls in the study. 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 and 3
to 6 patients will receive the highest amount of drug where severe side effects were not
observed. The amount of JNJ-38877605 in the patient's blood will be measured and the study
will also look at the effect of the drug on the disease. The patient may continue treatment
as long as there is benefit as assessed by the response assessments throughout the study and
the patient has no unacceptable side effects. A follow-up visit for each patient will take
place within 14 days after the patient takes the last dose of JNJ-38877605. JNJ-38877605 is
provided in 10, 50, and 100 mg capsules for oral use. JNJ-38877605 will initially be
administered once a day orally although the administration schedule may be modified at later
stages in the study. JNJ-38877605 will be provided as a take-home formulation in childproof
high-density polyethylene bottles.

Inclusion Criteria:

- Confirmed advanced or refractory solid tumor no longer eligible for approved

- Eastern Cooperative Oncology Group performance status test score of <=2

- Must meet protocol lab criteria which will include lab assessment of adequate bone
marrow function, liver function, and renal function.

Exclusion Criteria:

- Any medical condition that requires wound healing during the study (for example
chronic leg ulcers, gastric ulcer disease, or expected major surgery)

- Major surgery within 3 weeks before enrollment

- Decreased or deficient coagulability of blood (for example genetic defects such as
protein Z deficiency) or compliance problems in subjects required to take
anticoagulants (e.g., coumarin derivates, acetylsalicylic acid) which could result in
decreased or deficient coagulability

- Chemotherapy (for nitrosoureas and mitomycin C within 6 weeks), radiotherapy,
immunotherapy, or any other investigational agent within 3 weeks before study drug

- antibody therapy within 3 months before administration of JNJ-38877605

- brain metastases

- History of uncontrolled heart disease within 12 months before enrollment or any
protocol-defined cardiovascular abnormalities

- Patients with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

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 and tolerability of JNJ-38877605 by assessment of the adverse event profile (throughout the study), dose-limiting toxicity (Cycle 1), and the maximum tolerated dose.

Safety Issue:


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 Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

February 2008

Completion Date:

December 2010

Related Keywords:

  • Neoplasms
  • Advanced solid tumors
  • Refractory solid tumor
  • Antineoplastic protocol
  • Drug therapy
  • Pharmacokinetics
  • Met inhibitor
  • Neoplasms