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BEZ235 + paclitaxel

Phase 1

Metastatic or Locally Advanced Solid Tumors | Small molecule | Oncology |Novartis AG|Last Updated: Dec 9, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment110
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01285466A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without TrastuzumabPHASE1 COMPLETED 110 — — Jan 1, 2011Oct 1, 2014Dec 9, 202010 Belgium, Germany +3
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Study Endpoints
Primary Endpoints
Incidence of Dose limiting toxicities during the first cycle of treatment.
First treatment cycle (4 weeks)
Secondary Endpoints
Incidence of safety events during the whole treatment period (until progression of disease).
From start of treatment until disease progression
pharmacokinetics of BEZ235, BKM120 and paclitaxel given in combination, on Day 1, 8 and 22.
First treatment cycle (4 weeks)
Treatment efficacy (response to treatment according to RECIST criteria)
From start of treatment until disease progression
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BEZ235 + paclitaxelEXPERIMENTAL -
BKM120 + paclitaxelEXPERIMENTAL -
BEZ235 + paclitaxel + trastuzumabEXPERIMENTAL -
BKM120 + paclitaxel + trastuzumabEXPERIMENTAL -
Interventions
NameTypeDescription
BEZ235 + paclitaxelDRUG -
BKM120 + paclitaxelDRUG -
BEZ235 + paclitaxel + trastuzumabDRUG -
BKM120 + paclitaxel + trastuzumabDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Adult patients with metastatic or locally advanced solid tumors, for whom weekly paclitaxel treatment is indicated (BEZ235-paclitaxel /BKM120-paclitaxel treatment) * HER2+ metastatic or locally advanced breast cancer patients eligible for weekly paclitaxel and trastuzumab (BEZ...

Countries:BelgiumGermanyNetherlandsSpainSwitzerland
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