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Last Updated: May 21, 2022

CLINICAL TRIALS PROFILE FOR ALPELISIB


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All Clinical Trials for Alpelisib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01602315 ↗ A Phase Ib/II Study of BYL719 and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Terminated Novartis Pharmaceuticals Phase 1/Phase 2 2012-11-12 This was a multi-center, open-label, Phase Ib dose escalation /Phase II study in recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) patients considered to be resistant, ineligible or intolerant to platinum-based chemotherapy. The Phase Ib included three arms. Three different methods of administration and two different BYL719 formulations were studied to determine the MTD and/or RP2D of BYL719 in combination with cetuximab: Arm A - film-coated whole tablets were orally administered to patients who were able to swallow the tablets; Arm B - a drinkable suspension prepared from crushed film-coated tablets was administered orally to patients with swallowing dysfunction Arm C - a suspension from a dispersible tablet administered via G-tube, in patients with swallowing dysfunction. Arm C was used to investigate the pharmacokinetics (PK), compared to Arm A (film coated tablet), and safety of the dispersible tablet of the dispersible tablet formulation of BYL719. The Phase II investigated the clinical efficacy of BYL719 and consisted of an open label, randomized Phase II part investigating BYL719 in combination with cetuximab compared to cetuximab alone in patients resistant or intolerant to platinum and na├»ve to cetuximab (Scheme 1: Arm 1 and Arm 2), and a non-randomized Phase II part Scheme 2: Arm 3. In addition, patients who experienced disease progression in Arm 2 (cetuximab) were allowed to switch to the combination regimen (cross-over, Arm 2B). The safety of the BYL719 in combination with cetuximab was also further characterized in Arms 1, 2B and 3. Patients were treated until progression of disease), unacceptable toxicity, or withdrawal of informed consent, whichever occurred first (except for phase II Arm 2 had the opportunity to crossover to the combination treatment (Arm 2B). In the follow-up period all patients had to complete the safety follow-up assessments within 30 days after the last dose of the study treatment. Patients who did not have disease progression at the time of discontinuation of study treatment were radiologically followed for disease status until disease progression, initiation of subsequent anticancer therapies, or death, whichever occurred first. In addition, all patients enrolled in Phase II were followed for survival.
NCT01708161 ↗ A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors Terminated NantCell, Inc. Phase 1/Phase 2 2012-11-27 This was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. Patients were to be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. All patients were to be followed up. At a minimum, patients must have completed the safety follow-up assessments 30 days after the last dose of the study treatment.
NCT01708161 ↗ A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors Terminated Novartis Pharmaceuticals Phase 1/Phase 2 2012-11-27 This was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to estimate the MTD(s) and/or identify the recommended phase II dose(s) (RP2Ds) for the combination of BYL719 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. Patients were to be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurred first. All patients were to be followed up. At a minimum, patients must have completed the safety follow-up assessments 30 days after the last dose of the study treatment.
NCT01822613 ↗ Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC) Completed Novartis Pharmaceuticals Phase 1 2013-07-26 To study the safety and efficacy of the combination of LJM716 and BYL719 against currently available treatments of physician's choice in previously treated esophageal squamous cell carcinoma patients.
NCT01923168 ↗ Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women Completed Novartis Pharmaceuticals Phase 2 2014-03-11 The purpose of the study was to determine whether treatment with a PI3K inhibitor plus letrozole led to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Alpelisib

Condition Name

Condition Name for Alpelisib
Intervention Trials
Breast Cancer 14
Advanced Breast Cancer 5
HER2-negative Breast Cancer 4
Metastatic Breast Cancer 4
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Condition MeSH

Condition MeSH for Alpelisib
Intervention Trials
Breast Neoplasms 30
Carcinoma 7
Neoplasms 7
Carcinoma, Squamous Cell 5
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Clinical Trial Locations for Alpelisib

Trials by Country

Trials by Country for Alpelisib
Location Trials
United States 166
Italy 79
Spain 43
China 36
Japan 26
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Trials by US State

Trials by US State for Alpelisib
Location Trials
Texas 13
New York 11
California 11
Massachusetts 9
Missouri 8
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Clinical Trial Progress for Alpelisib

Clinical Trial Phase

Clinical Trial Phase for Alpelisib
Clinical Trial Phase Trials
Phase 3 7
Phase 2 19
Phase 1/Phase 2 8
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Clinical Trial Status

Clinical Trial Status for Alpelisib
Clinical Trial Phase Trials
Recruiting 22
Not yet recruiting 11
Active, not recruiting 5
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Clinical Trial Sponsors for Alpelisib

Sponsor Name

Sponsor Name for Alpelisib
Sponsor Trials
Novartis Pharmaceuticals 26
Novartis 6
National Cancer Institute (NCI) 3
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Sponsor Type

Sponsor Type for Alpelisib
Sponsor Trials
Industry 55
Other 26
NIH 3
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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
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Baxter

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