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Phase 2

Phase 1

Relapsed or Refractory Hodgkin Lymphoma | Small molecule | Oncology |Johnson & Johnson|Last Updated: Nov 20, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01572519A Study of JNJ-40346527 in Patients With Relapsed or Refractory Hodgkin LymphomaPHASE1 COMPLETED 21 — — Jul 17, 2012Aug 13, 2013Nov 20, 20204 France, Germany
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Study Endpoints
Primary Endpoints
Phase 1 maximum tolerated dose (MTD) for JNJ-40346527
After completion of Cycle 1 (21 days of dosing) in the last subject in Phase 1
Phase 2 overall response rate
Up to 6 months after the last subject is enrolled
Secondary Endpoints
Duration of response (DOR)
Up to 6 months after the last subject is enrolled
Progression-free survival (PFS)
Up to 6 months after the last subject is enrolled
The number of participants affected by an adverse event
Up to 30 days after the last dose of study medication
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
JNJ-40346527EXPERIMENTAL -
Interventions
NameTypeDescription
Phase 1, Cohort 1DRUGType=exact number, unit=mg, number=150, form=capsule, route=oral use. Capsule is taken once daily.
Phase 1, Cohort 2DRUGType=exact number, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once daily.
Phase 1, Cohort 3DRUGType=exact number, unit=mg, number=450, form=capsule, route=oral use. Capsule is taken once daily.
Phase 1, Cohort 4DRUGType=exact number, unit=mg, number=600, form=capsule, route=oral use. Capsule is taken once daily.
Phase 2DRUGJNJ-40346527 at the recommended dose determined in Phase 1
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

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 o...

Countries:FranceGermany
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