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Generated: September 23, 2019

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CLINICAL TRIALS PROFILE FOR ALPELISIB

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Clinical Trials for Alpelisib

Trial ID Title Status Sponsor Phase 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 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 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 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.
NCT02620839 Phase Ib Study of Alpelisib With Cisplatin in Patients With HPV+ Solid Tumor Malignancies Not yet recruiting Pamela Munster Phase 1 This is a Phase Ib dose escalation / expansion study with the combination of alpelisib and weekly cisplatin. Dose escalation will follow standard 3+3 design. During dose escalation, two dose levels of weekly cisplatin (30 and 35 mg/m2, respectively) will be evaluated in combination with escalating doses of alpelisib in parallel. Cohort B (cisplatin 35 mg/m2) at a given dose level of alpelisib to open only after corresponding A cohort (cisplatin 30 mg/m2) at the same dose level of alpelisib has cleared DLT window. Cohorts A and B may enroll in parallel (e.g., Cohort 3A may enroll in parallel with Cohort 2B) as shown below in the dose escalation schema. Intermediate dose levels and alternative dosing schedules may be investigated per the discretion of Principal Investigator using same 3+3 dose escalation schema (e.g. cisplatin administered days 1, 8 of 21 day cycle).
NCT02624557 Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment. Recruiting Novartis Pharmaceuticals Phase 1 To characterize the pharmacokinetics and safety of alpelisib in subjects with hepatic impairment compared to matched healthy control subjects.
NCT02734615 Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers Recruiting Novartis Pharmaceuticals Phase 1 To characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LSZ102 as a single agent and in combination with either LEE011 or BYL719 in adult patients with locally advanced or metastatic ER+ breast cancer who have progressed after endocrine therapy.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Alpelisib

Condition Name

Condition Name for Alpelisib
Intervention Trials
Breast Cancer 2
Pancreatic Neuroendocine Neoplasms 1
Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7 1
Head and Neck Squamous Cell Cancer 1
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Condition MeSH

Condition MeSH for Alpelisib
Intervention Trials
Breast Neoplasms 6
Carcinoma, Squamous Cell 2
Neoplasms 2
Liver Diseases 1
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Clinical Trial Locations for Alpelisib

Trials by Country

Trials by Country for Alpelisib
Location Trials
United States 37
Italy 20
Spain 14
Japan 10
Korea, Republic of 6
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Trials by US State

Trials by US State for Alpelisib
Location Trials
New York 3
Texas 2
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 1
Phase 2 2
Phase 1 7
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Clinical Trial Status

Clinical Trial Status for Alpelisib
Clinical Trial Phase Trials
Not yet recruiting 6
Recruiting 3
Active, not recruiting 2
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Clinical Trial Sponsors for Alpelisib

Sponsor Name

Sponsor Name for Alpelisib
Sponsor Trials
Novartis Pharmaceuticals 6
National Cancer Institute (NCI) 1
M.D. Anderson Cancer Center 1
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Sponsor Type

Sponsor Type for Alpelisib
Sponsor Trials
Industry 8
Other 5
NIH 1
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