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Alpelisib Pill

Phase 2

Endometroid Endometrial Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Mar 3, 2026

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment51
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05154487A Study of Alpelisib and Fulvestrant to Treat Endometrial CancerPHASE2 ACTIVE NOT_RECRUITING 51 — — Sep 11, 2024Nov 1, 2028Mar 3, 202618 United States
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Study Endpoints
Primary Endpoints
Response rate
Response to treatment is assessed by RECIST Version 1.1 criteria every 8 weeks with CT scan or MRI through completion of treatment (complete or partial response). Patients receive treatment until disease progression and are followed for 5 years.

To determine the objective response rate of the combination of alpelisib and fulvestrant in patients with advanced, persistent or recurrent PIK3CA-mutated ER-positive endometrioid endometrial cancer. Respnse criteria based on RECIST Version 1.1 (complete or partial response).

Secondary Endpoints
Drug Toxicity (Side Effects)
Side effects are monitor from the start of treatment to discontinuation of treatment assessed every 4 weeks. Patients are treated until disease progression and are followed for 5 years.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Apelisib and FulvestrantEXPERIMENTALalpelisib 300mg orally daily of each 28-day cycle fulvestrant 500mg IM on Day 1 and Day 15 of Cycle 1, then 500mg IM on Day 1 of each 28-day cycle.
Interventions
NameTypeDescription
Alpelisib PillDRUGKinase inhibitor
Fulvestrant injectionDRUGestrogen receptor agonist
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: 1. Patient must have advanced (FIGO 2014 Stage III or IV), persistent, or recurrent endometrial carcinoma, which is not likely to be curable by surgery or radiotherapy. Histologic confirmation of recurrent disease is required. For cases of persistent disease, histologic confirma...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05154487studyFirstPostDate: changed