- Trials with a EudraCT protocol (4)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
4 result(s) found for: PIK3CA-related overgrowth spectrum.
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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) | |||||||||||||
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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: 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 (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: 2016-000558-37 | Sponsor Protocol Number: ARQ092-103 | Start Date*: 2017-02-22 | |||||||||||
Sponsor Name:ArQule, Inc. | |||||||||||||
Full Title: A Phase 1/2 Study of ARQ 092 in Patients with Overgrowth Diseases and Vascular Anomalies with Genetic Alterations of the PI3K/AKT Pathway | |||||||||||||
Medical condition: subjects (at least 6 years) suffering from diseases overgrowth and vascular anomalies with genetic alterations of the PI3K / AKT pathway. | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Completed) FR (Ongoing) ES (Temporarily Halted) GB (GB - no longer in EU/EEA) DE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2021-001369-19 | Sponsor Protocol Number: MK-7075-006 | Start Date*: 2021-10-20 | ||||||||||||||||
Sponsor Name:MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC. | ||||||||||||||||||
Full Title: A Multicenter, Open-label, Phase 2, Extension Trial to Study the Long-term Safety in Participants With PROS or Proteus Syndrome Who Are Currently Being Treated with Miransertib in Other Studies | ||||||||||||||||||
Medical condition: PIK3CA-related overgrowth spectrum (PROS) and Proteus Syndrome (PS) | ||||||||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | |||||||||||||||||
Trial protocol: IT (Trial now transitioned) | ||||||||||||||||||
Trial results: (No results available) |
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