A Study of JNJ-40346527 in Patients With Relapsed or Refractory Hodgkin Lymphoma
NCT01572519 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2020-11-20
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.
Conditions
- Relapsed or Refractory Hodgkin Lymphoma
Interventions
- 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
Sponsors & Collaborators
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-07-17
- Primary Completion
- 2013-08-13
- Completion
- 2013-08-13
Countries
- France
- Germany
Study Locations
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