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Everolmus

Phase 1

Non-Hodgkin's Lymphoma | Small molecule | Oncology |Novartis AG|Last Updated: Dec 21, 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
UNCONTROLLED
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00622258A Phase I Dose Escalation Study of RAD001 Administered in Patients With Relapsed or Refractory Non-Hodgkin's LymphomaPHASE1 COMPLETED 13 — — Mar 1, 2008Jan 1, 2014Dec 21, 20208 Japan
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Study Endpoints
Primary Endpoints
To assess the safety and tolerability of RAD001 in Japanese patients with relapsed or refractory non-Hodgkin's lymphoma
whole study period
To assess the pharmacokinetics in Japanese patients
1st sycle
Secondary Endpoints
To seek preliminary evidence of efficacy in this population
Every 2 cycles
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EverolimusEXPERIMENTAL -
Interventions
NameTypeDescription
EverolmusDRUG -
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Eligibility Criteria
Age Range20 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion criteria: * Patients must have histopathologically confirmed diagnosis of non-Hodgkin's lymphoma * Patients must have disease that is either relapsed or refractory after at least one prior treatment regimen and must not be eligible for any standard treatments * Patients must not have rece...

Countries:Japan
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