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AMN107- NILOTINIB

Phase 2

Gastrointestinal Stromal Tumors (GIST) | Small molecule | Oncology |Novartis AG|Last Updated: Jun 22, 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 Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00633295Phase II Study Aiming to Evaluate the Efficacy and Safety of Nilotinib Patients With Gastrointestinal Stromal Tumors (GIST) Resistant or Intolerant to Imatinib and or to 2nd Line Tyrosine Kinas (TK) InhibitorPHASE2 COMPLETED 9 — — Jun 1, 2008May 1, 2010Jun 22, 20173 Israel
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Study Endpoints
Primary Endpoints
To evaluate the efficacy of nilotinib in GIST patients resistant or intolerant to imatinib and or 2nd line TK inhibitor as measured by tumor up take of FDG PET quantitated by maximum
6 months
Secondary Endpoints
To assess the safety and tolerability of nilotinib as measured by rate and severity of adverse events
6 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
nilotinibEXPERIMENTAL -
Interventions
NameTypeDescription
AMN107- NILOTINIBDRUGThe dose of nilotinib will be 400 mg bid.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion criteria: * Age ≥ 18 years at Visit 1 * Radiological confirmation of disease progression (CT scan PET-CT, or MRI) during imatinib therapy, on 600- 800 mg per day for at least 6 weeks. * Radiological confirmation of disease progression (CT scan or MRI and PET-CT) during 2nd line TK inhibit...

Countries:Israel
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