- Trials with a EudraCT protocol (17)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
17 result(s) found for: Alpelisib.
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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 | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: FR (Ongoing) HU (Ongoing) DE (Temporarily Halted) CZ (Ongoing) BE (Completed) ES (Ongoing) NL (Prematurely Ended) GB (GB - no longer in EU/EEA) AT (Completed) IT (Prematurely Ended) SK (Ongoing) SE (Prematurely Ended) BG (Temporarily Halted) FI (Completed) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2020-005896-12 | Sponsor Protocol Number: CBYL719F12401 | Start Date*: Information not available in EudraCT | |||||||||||
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) | |||||||||||||
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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 | |||||||||||||
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Population Age: Adults, Elderly | Gender: Female | ||||||||||||
Trial protocol: BE (Completed) PT (Completed) FI (Completed) CZ (Completed) DK (Completed) SK (Completed) FR (Completed) NL (Completed) ES (Ongoing) DE (Ongoing) IT (Ongoing) | |||||||||||||
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 (Ongoing) NO (Completed) AT (Ongoing) BG (Completed) SI (Completed) PL (Ongoing) HR (Ongoing) GR (Ongoing) RO (Ongoing) PT (Temporarily Halted) | ||
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 | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Ongoing) HU (Ongoing) SK (Ongoing) CZ (Ongoing) IT (Ongoing) IE (Ongoing) ES (Ongoing) BE (Ongoing) FI (Ongoing) DK (Ongoing) PT (Ongoing) BG (Ongoing) PL (Ongoing) | |||||||||||||
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) | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Ongoing) NO (Ongoing) NL (Ongoing) FR (Ongoing) IT (Ongoing) | |||||||||||||
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 | |||||||||||||
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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: (No results available) |
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 (Ongoing) | ||
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 | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: ES (Completed) DE (Completed) GB (GB - no longer in EU/EEA) BE (Ongoing) NL (Completed) DK (Trial now transitioned) IT (Ongoing) | |||||||||||||
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 | |||||||||||||
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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) | ||||||||||||||||||
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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 (Ongoing) | ||
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 | |||||||||||||
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Population Age: Adults, Elderly | Gender: Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) BE (Prematurely Ended) PT (Prematurely Ended) ES (Prematurely Ended) CZ (Ongoing) PL (Prematurely Ended) 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 (Ongoing) BE (Ongoing) | ||
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 (Ongoing) | ||
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 (Ongoing) GB (GB - no longer in EU/EEA) NL (Ongoing) DE (Completed) ES (Ongoing) | ||
Trial results: (No results available) |
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