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Pazopanib plus Gemcitabine

Phase 2

Leiomyosarcoma or Carcinosarcoma | Small molecule | Oncology |Novartis AG|Last Updated: Nov 15, 2024

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment58
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02203760Pazopanib Vs. Pazopanib Plus GemcitabinePHASE2 ACTIVE NOT_RECRUITING 58Oct 16, 2019Dec 31, 2024Nov 15, 20249 Germany
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Study Endpoints
Primary Endpoints
Progression free survival assessed as rate of patients without progression Second malignancy or clinical progression - patients with unknown or missing PFS will be treated as non-responder
6 months
Secondary Endpoints
Objective response rate (RECIST v1.1 criteria)
One year
Safety - side effects
One year
Quality of life (EORTC QLQ-C30)
One year
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Pazopanib plus GemcitabineEXPERIMENTALArm A: Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or
PazopanibACTIVE_COMPARATORPazopanib 800 mg orally once daily
Interventions
NameTypeDescription
Pazopanib plus GemcitabineDRUGPazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or
PazopanibDRUGPazopanib 800 mg orally once daily
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: 1. Subjects must provide informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up. Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) an...

Countries:Germany
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT02203760studyFirstPostDate: changed