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
Price :
$35
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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
- 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.