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An Open-label, Multicenter, Phase 1/2 Study of JNJ-40346527, an FMS Inhibitor, in Subjects With Relapsed or Refractory Hodgkin Lymphoma

Phase 1
18 Years
Open (Enrolling)
Relapsed or Refractory Hodgkin Lymphoma

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Trial Information

An Open-label, Multicenter, Phase 1/2 Study of JNJ-40346527, an FMS Inhibitor, in Subjects With Relapsed or Refractory Hodgkin Lymphoma

This is an open-label (individuals will know the identity of study treatments),
dose-escalation study to evaluate the clinical efficacy, safety, and pharmacokinetics (PK;
study of what the body does to a drug) of JNJ-40346527. Up to 38 subjects could be enrolled
in the Phase 1 portion of the study and up to 30 subjects could be enrolled in the Phase 2
portion of the study. During the Phase 1 portion of the study, dose escalation of
JNJ-40346527 will start at 150 mg (Cohort 1) once daily up to the maximum tolerated dose
(MTD) or the highest planned dose (600 mg once daily); twice daily dosing may also be
performed if deemed necessary. A Study Evaluation Team (SET) will review all available data
after 1 cycle (21 days) of treatment for each cohort before any additional dose escalation
occurs and will also determine the recommended Phase 2 dose for the expansion cohort. This
study will consist of 3 periods: a screening period (from signing of informed consent until
immediately before dosing), an open-label treatment period (from the first dose of study
drug until the end-of-treatment visit), and a follow-up period (after the end-of-treatment
visit). All patients will participate in the screening and treatment period. Patients will
be administered JNJ-40346527 continuously until disease progression, or unacceptable
toxicity (based on investigator assessment). The National Cancer Institute-Common
Terminology Criteria for Adverse Events will be used to grade toxicity throughout the study.
Disease response will be assessed according to the Revised Response Criteria for Malignant
Lymphoma. Treatment will continue until disease progression or unacceptable toxicity (based
on investigator assessment) occurs. Only patients who discontinue study drug before disease
progression or discontinue due to treatment-related Grade 3 or higher toxicity will continue
in the follow-up period. Serial PK samples will be collected in Cycle 1 as detailed in the
protocol. Safety will be monitored throughout the study.

Inclusion Criteria:

- Patients with histopathologically confirmed initial diagnosis of Hodgkin lymphoma and
who have disease that has relapsed or is refractory that is progressing or active and
requires treatment after at least 1 appropriate therapy

Exclusion Criteria:

- Known brain metastases or leptomeningeal disease

- Other malignancy within past 5 years

- Has any condition that, in the opinion of the investigator, would make study
participation not be in the best interest (eg, compromise the well-being) of the
patient or that could prevent, limit, or confound the protocol-specified assessments

- QTc prolongation at screening or other factors that increase the risk of QT
prolongation such as diagnosis or family history of long-QT syndrome, diagnosed or
suspected congenital long QT syndrome, or concomitant use of medication that can
prolong the QT interval

- Taking CYP3A4 substrate drugs with a narrow therapeutic index (eg, alfentanil,
astemizole, sirolimus, tacrolimus, terfenadine)

Type of Study:


Study Design:

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

Outcome Measure:

Phase 1 maximum tolerated dose (MTD) for JNJ-40346527

Outcome Time Frame:

After completion of Cycle 1 (21 days of dosing) in the last subject in Phase 1

Safety Issue:


Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

June 2012

Completion Date:

February 2014

Related Keywords:

  • Relapsed or Refractory Hodgkin Lymphoma
  • Relapsed Hodgkin lymphoma
  • Refractory Hodgkin lymphoma
  • JNJ-40346527
  • Dose-escalation
  • Pharmacokinetics
  • Hodgkin Disease
  • Lymphoma



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