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Patupilone and Omeprazole

Phase 1

Solid Tumors | Small molecule | Oncology |Novartis AG|Last Updated: Dec 8, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00420615Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced MalignanciesPHASE1 COMPLETED 34Dec 1, 2006 -Dec 8, 20201 United States
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Study Endpoints
Primary Endpoints
To evaluate the effects of patupilone on the pharmacokinetics of midazolam in patients with advanced malignancies.
Day 1 (0.5h, 1h, 1.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h), Day 29 (0.5h, 1h, 1.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h)
To evaluate the effects of patupilone on the pharmacokinetics of omeprazole in patients with advanced malignancies
Day 1 (0.33h (20m), 0.67h (40m), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h)
Secondary Endpoints
To evaluate the safety and tolerability of Patupilone when administered concomitantly with midazolam in patients with advanced malignancies.
at each visit (week 1, week 2, week 5, and end of study)
To evaluate the safety and tolerability of Patupilone when administered concomitantly with omeprazole in patients with advanced malignancies.
at each visit (week 1, week 2, week 5, and end of study)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Patupilone and OmeprazoleEXPERIMENTALpatupiloe + omeprazole
patupilone + midalzolamEXPERIMENTALpatupilone + midalzolam
Interventions
NameTypeDescription
Patupilone and OmeprazoleDRUG -
Patupilone + MidalzolamDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Male or female patients 18 years or older * Histologically documented advanced solid tumor, who have failed standard systemic therapy, or for whom standard systemic therapy does not exist * Life expectancy of 3 months or more * Patients with adequate hematologic parameters Ex...

Countries:United States
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