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AMN107

Phase 2

Leukemia, Myeloid, Chronic | Small molecule | Oncology |Novartis AG|Last Updated: Mar 6, 2017

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 Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00264160Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate TherapyPHASE2 COMPLETED 36 — — May 1, 2006Aug 1, 2009Mar 6, 20174 Israel
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Study Endpoints
Primary Endpoints
Cytogenetic response within 12 months
Every 6 months for 12 months
Secondary Endpoints
To determine the rate of hematologic response at 12 months
Every Visit for 12 months
To determine the rate of molecular response at 12 months
Every 3 months for 12 months
To evaluate the time to cytogenetic and molecular response
At 12 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AMN107EXPERIMENTAL -
Interventions
NameTypeDescription
AMN107DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML in blast crisis, accelerated or chronic phase * Males or females ≥ 18 years of age Exclusion Criteria: * Impaired cardiac function * Acute or chronic liver or renal disease * Use of therapeutic coumadi...

Countries:Israel
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