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Clinical trials for Alpelisib

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    17 result(s) found for: Alpelisib. Displaying page 1 of 1.
    EudraCT Number: 2019-002741-37 Sponsor Protocol Number: CBYL719G12301 Start Date*: 2020-04-07
    Sponsor Name:Novartis Pharma AG
    Full Title: EPIK-B2: A two part, Phase III, multicenter, randomized (1:1), double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with trastuzumab and per...
    Medical condition: HER2-positive advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) HU (Prematurely Ended) DE (Temporarily Halted) CZ (Completed) BE (Completed) ES (Ongoing) NL (Prematurely Ended) GB (GB - no longer in EU/EEA) AT (Completed) IT (Prematurely Ended) SK (Prematurely Ended) SE (Prematurely Ended) BG (Temporarily Halted) GR (Completed) FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005896-12 Sponsor Protocol Number: CBYL719F12401 Start Date*: 2021-10-20
    Sponsor Name:Novartis Pharma AG
    Full Title: EPIK-P3: A phase II study to evaluate the long-term safety and efficacy of alpelisib in patients with PIK3CA-Related Overgrowth Spectrum (PROS) who previously participated in Study CBYL719F12002 (E...
    Medical condition: PIK3CA-related overgrowth spectrum (PROS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10010331 - Congenital, familial and genetic disorders 10081236 PIK3CA related overgrowth spectrum PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) IE (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004682-40 Sponsor Protocol Number: CBYL719K12301 Start Date*: 2021-06-16
    Sponsor Name:Novartis Pharma AG
    Full Title: EPIK-O: A Phase III, multi-center, randomized (1:1), open-label, active-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with olaparib as compared to single a...
    Medical condition: Platinum-resistant or refractory, high-grade serous ovarian cancer with no germline BRCA mutation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033130 Ovarian cancer NOS LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed) PT (Completed) FI (Trial now transitioned) CZ (Completed) DK (Completed) SK (Completed) FR (Completed) NL (Completed) ES (Ongoing) DE (Trial now transitioned) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002637-11 Sponsor Protocol Number: CBYL719H12301 Start Date*: 2020-03-18
    Sponsor Name:Novartis Pharma AG
    Full Title: EPIK-B3: A Phase III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with nab-paclitaxel in patients with adv...
    Medical condition: Advanced triple negative breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) FR (Completed) SK (Completed) DE (Completed) GB (GB - no longer in EU/EEA) IT (Completed) NO (Completed) AT (Completed) BG (Completed) SI (Completed) PL (Completed) HR (Completed) GR (Completed) RO (Completed) PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-001966-39 Sponsor Protocol Number: CBYL719C2303 Start Date*: 2021-09-27
    Sponsor Name:Novartis Pharma AG
    Full Title: EPIK-B5: A Phase III, randomized, double-blind, placebo-controlled study of alpelisib (BYL719) in combination with fulvestrant for men and postmenopausal women with HR-positive, HER2-negative advan...
    Medical condition: Hormone receptor positive, HER2-negative advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) HU (Trial now transitioned) SK (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned) IE (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) FI (Trial now transitioned) DK (Trial now transitioned) PT (Trial now transitioned) BG (Trial now transitioned) PL (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000561-16 Sponsor Protocol Number: CBYL719F12201 Start Date*: 2021-07-01
    Sponsor Name:Novartis Pharma AG
    Full Title: EPIK-P2 - A Phase II double-blind study with an upfront, 16-week randomized, placebo-controlled period, to assess the efficacy, safety and pharmacokinetics of alpelisib (BYL719) in pediatric and ad...
    Medical condition: PIK3CA-related overgrowth spectrum (PROS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10010331 - Congenital, familial and genetic disorders 10081236 PIK3CA related overgrowth spectrum PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) NO (Trial now transitioned) NL (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-000340-42 Sponsor Protocol Number: CBYL719C2301 Start Date*: 2015-07-21
    Sponsor Name:Novartis Pharma Services AG
    Full Title: SOLAR-1: A phase III randomized double-blind, placebo controlled study of alpelisib in combination with fulvestrant for men and postmenopausal women with hormone receptor positive, HER2-negative ad...
    Medical condition: Hormone receptor positive, HER2-negative advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) AT (Completed) NL (Completed) CZ (Completed) HU (Completed) IT (Completed) BE (Completed) FR (Completed) ES (Completed) GR (Completed) GB (GB - no longer in EU/EEA) BG (Completed) PT (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2021-000845-42 Sponsor Protocol Number: CBYL719A0HR01T Start Date*: 2022-04-04
    Sponsor Name:CCGCRO
    Full Title: Impact of time of alpelisib administration, concomitant fasting and low carbohydrate diet on alpelisib toxicity and efficacy; a pilot randomized controlled phase IIb trial - ITACA
    Medical condition: metastatic breast cancer HER2- HR+ PIK3CA+
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HR (Suspended by CA)
    Trial results: (No results available)
    EudraCT Number: 2016-004586-67 Sponsor Protocol Number: CBYL719X2402 Start Date*: 2017-07-13
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: A phase II, multicenter, open-label, two-cohort, noncomparative study to assess the efficacy and safety of alpelisib plus fulvestrant or letrozole in patients with PIK3CA mutant, hormone receptor (...
    Medical condition: Hormone receptor positive, HER2-negative advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) BE (Completed) NL (Completed) DK (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-005882-15 Sponsor Protocol Number: CBYL719A03201 Start Date*: 2021-05-12
    Sponsor Name:Novartis Pharma AG
    Full Title: Open-label, multicenter, pilot-trial evaluating the safety and utility of a hybrid decentralized clinical trial (DCT) approach using a TELEmedicine platform in patients with HR-positive/HER2-negati...
    Medical condition: HR-positive/HER2-negative advanced breast cancer with a PIK3CA mutation
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-005639-65 Sponsor Protocol Number: GEICAM/2017-01_IBCSG62-20_BIG18-04 Start Date*: 2021-05-25
    Sponsor Name:GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)
    Full Title: A randomized phase III trial of trastuzumab + ALpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced BrEasT cancer. “ALPHABET ...
    Medical condition: PIK3CA mutated HER2+ advanced or relapsed breast cancer (BC) previously treated with trastuzumab and trastuzumab emtansine (T-DM1)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER2 positive breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) AT (Completed) FR (Prematurely Ended) NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-000154-19 Sponsor Protocol Number: UC-0105/1701 Start Date*: 2017-07-19
    Sponsor Name:UNICANCER
    Full Title: A phase II randomized trial comparing alpelisib and fulvestrant versus chemotherapy as maintenance therapy in patients with PIK3CA mutated advanced breast cancer
    Medical condition: PIK3CA mutated, HR+/Her2- metastatic breast cancer who do not present progressive disease after 6-8 cycles of 1st or second line chemotherapy.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-006017-34 Sponsor Protocol Number: CBYL719X2104 Start Date*: 2013-03-05
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase Ib dose escalation/randomized phase II, multicenter, open-label study of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma
    Medical condition: Head and Neck Carcinoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-000690-36 Sponsor Protocol Number: TED14856 Start Date*: 2018-12-17
    Sponsor Name:SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    Full Title: A Phase 1/2 Study for the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamics Evaluation of SAR439859, Administered Orally as Monotherapy, then in Combination with Palbociclib in Postmenopausal...
    Medical condition: Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Trial now transitioned) PT (Prematurely Ended) ES (Prematurely Ended) CZ (Completed) PL (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-003581-41 Sponsor Protocol Number: J2J-MC-JZLA Start Date*: 2020-09-08
    Sponsor Name:Eli Lilly and Company
    Full Title: EMBER: A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination with Anticancer Therapies for Patients with ER+ Locally Advanced or Metastatic Breast Cancer and Other Select ...
    Medical condition: ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004414-35 Sponsor Protocol Number: IMPRESSNorway Start Date*: 2021-02-19
    Sponsor Name:Oslo University Hospital
    Full Title: Improving public cancer care by implementing precision medicine in Norway
    Medical condition: Patients with a biomarker indicating response to IMP can be included in IMPRESS-Norway. Patients with disease characteristics covered in present indications for the IMP are not eligible.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-004727-37 Sponsor Protocol Number: CAAA603A12101 Start Date*: 2019-02-18
    Sponsor Name:Advanced Accelerator Applications International SA
    Full Title: A Phase I/IIa open-label, multi-center study to evaluate the safety, tolerability, whole-body distribution, radiation dosimetry and anti-tumor activity of [177Lu]-NeoB administered in patients with...
    Medical condition: Solid tumors known to overexpress GRPR and with [68Ga]-NeoB lesion uptake
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Trial now transitioned) DE (Completed) ES (Ongoing) FR (Trial now transitioned)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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