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A Phase IA, Multicenter, Open-label Dose Escalation Study of Oral BYL719, in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have a Mutation of the PIK3CA Gene

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Trial Profile

A Phase IA, Multicenter, Open-label Dose Escalation Study of Oral BYL719, in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have a Mutation of the PIK3CA Gene

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 08 Nov 2021

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At a glance

  • Drugs Alpelisib (Primary) ; Fulvestrant (Primary)
  • Indications Advanced breast cancer; Cervical cancer; Colon cancer; Endometrial cancer; Rectal cancer; Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Novartis; Novartis Pharmaceuticals

Most Recent Events

  • 01 Jul 2021 Results of updated analysis from the SOLAR-1 (n=341) and X2101(n=52) trials assessing long-term disease control in PIK3CA -mutated, HR-positive, HER2-negative advanced breast cancer, published in the Oncologist
  • 08 Jun 2021 Results from the SOLAR-1 study and CBYL719X2101 (X2101) study reporting the long term disease control in patients with hormone receptor-positive (HR+), PIK3CA-altered advanced breast cancer presented at the 57th Annual Meeting of the American Society of Clinical Oncology
  • 19 Jun 2020 Status changed from active, no longer recruiting to completed.

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