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Last Updated: May 11, 2021

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CLINICAL TRIALS PROFILE FOR ALPELISIB

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All Clinical Trials for Alpelisib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02058381 A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer Active, not recruiting Novartis Pharmaceuticals Phase 1 2014-05-01 Based on the evidence acquired in the post-menopausal setting with everolimus and on pre-clinical evidences supporting the investigation of PI3K inhibitors, such as alpelisib and buparlisib, in combination with endocrine therapy in hormone receptor-positive MBC, the purpose of this phase Ib trial is to assess the maximum tolerated dose (MTD) and/or the RP2D(s), to characterize the safety and tolerability, to determine the single and multiple dose PK profile and assess the preliminary anti-tumor activity of alpelisib and buparlisib in combination with tamoxifen plus goserelin acetate in premenopausal hormone receptor-positive advanced breast cancer patientsgroup.
NCT02077933 Study of Safety and Efficacy of Alpelisib With Everolimus or Alpelisib With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors Active, not recruiting Novartis Pharmaceuticals Phase 1 2014-05-01 Dose escalation part: to determine the highest dose of alpelisib administered on a daily basis when given in combination with daily everolimus or in combination with daily everolimus and exemestane. Dose expansion part: To describe safety and tolerability of the alpelisib and everolimus or alpelisib, everolimus and exemestane combinations.
NCT02437318 Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment. Recruiting Novartis Pharmaceuticals Phase 3 2015-07-01 To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Alpelisib

Condition Name

Condition Name for Alpelisib
Intervention Trials
Breast Cancer 4
Ovarian Cancer 2
Breast Neoplasms 2
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Condition MeSH

Condition MeSH for Alpelisib
Intervention Trials
Breast Neoplasms 13
Carcinoma, Squamous Cell 2
Triple Negative Breast Neoplasms 2
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Clinical Trial Locations for Alpelisib

Trials by Country

Trials by Country for Alpelisib
Location Trials
United States 40
Italy 20
Spain 14
Japan 10
Korea, Republic of 8
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Trials by US State

Trials by US State for Alpelisib
Location Trials
Texas 4
New York 3
Massachusetts 2
Florida 2
Arizona 2
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Clinical Trial Progress for Alpelisib

Clinical Trial Phase

Clinical Trial Phase for Alpelisib
Clinical Trial Phase Trials
Phase 3 4
Phase 2 8
Phase 1/Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Alpelisib
Clinical Trial Phase Trials
Not yet recruiting 18
Recruiting 4
Active, not recruiting 2
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Clinical Trial Sponsors for Alpelisib

Sponsor Name

Sponsor Name for Alpelisib
Sponsor Trials
Novartis Pharmaceuticals 12
Novartis 3
National Cancer Institute (NCI) 2
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Sponsor Type

Sponsor Type for Alpelisib
Sponsor Trials
Industry 17
Other 12
NIH 2
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Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Boehringer Ingelheim
Dow
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Baxter

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