NCT01572519

A Study of JNJ-40346527 in Patients With Relapsed or Refractory Hodgkin Lymphoma

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety, pharmacokinetics, and preliminary efficacy information of JNJ-40346527 in patients with relapsed or refractory Hodgkin lymphoma.

Detailed description

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 (although planned, the study did not move forward to the Phase 2 portion). 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.

Conditions

• Relapsed or Refractory Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Phase 1, Cohort 1	Type=exact number, unit=mg, number=150, form=capsule, route=oral use. Capsule is taken once daily.
DRUG	Phase 1, Cohort 2	Type=exact number, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once daily.
DRUG	Phase 1, Cohort 3	Type=exact number, unit=mg, number=450, form=capsule, route=oral use. Capsule is taken once daily.
DRUG	Phase 1, Cohort 4	Type=exact number, unit=mg, number=600, form=capsule, route=oral use. Capsule is taken once daily.
DRUG	Phase 2	JNJ-40346527 at the recommended dose determined in Phase 1

Timeline

• Start date: 2012-07-17
• Primary completion: 2013-08-13
• Completion: 2013-08-13
• First posted: 2012-04-06
• Last updated: 2020-11-20

Locations

4 sites across 2 countries: France, Germany