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BGT226

Phase 1

Solid Tumors | Small molecule | Oncology |Novartis AG|Last Updated: Dec 17, 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 Enrollment57
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00600275A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast CancerPHASE1 COMPLETED 57Dec 1, 2007 -Dec 17, 20206 United States, Canada +1
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Study Endpoints
Primary Endpoints
Maximum Tolerated Dose (MTD) of BGT226 (Phase I dose escalation) Safety and tolerability of BGT226 (all patients) Clinical tumor response in patients with advanced breast cancer (Phase II)
throughout the study
Secondary Endpoints
Pharmacodynamics Changes in biological markers indicative of the inhibitory effect of BGT226. Changes in cellular physiology as assessed by Positron Emission Tomography (PET) imaging
throughout the study
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BGT226EXPERIMENTAL -
Interventions
NameTypeDescription
BGT226DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion criteria: All patients * Histologically-confirmed, advanced solid tumors * Progressive, recurrent unresectable disease Phase II expansion part (advanced breast cancer) * Confirmed positive hormone receptor (estrogen receptor and/or progesterone receptor) or positive HER-2 expression st...

Countries:United StatesCanadaSpain
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