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A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene

Estrogen Receptor Positive Breast Cancer Clinical Trial

Official title:
A Phase IA, Multicenter, Open-label Dose Escalation Study of Oral BYL719, in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene

Clinical Trial Summary

This is a first-in-man trial, in which BYL719 will be administered to adult patients with advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease has progressed despite standard therapy or for whom no standard therapy exists. A combination of BYL719 with fulvestrant will also be investigated in post-menopausal patients with locally advanced or metastatic breast cancer whose tumors have an alteration of the PIK3CA gene. The single agent MTD dose expansion cohort and the fulvestrant combination MTD dose expansion cohort will also include ER+/HER2- breast cancer patients whose tumors have the wild type PIK3CA gene

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Advanced Solid Tumors With an Alteration of the PIK3CA Gene
  • Breast Neoplasms
  • Estrogen Receptor Positive Breast Cancer
  • Neoplasms
Clinical Trial Details
NCT number NCT01219699
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 1
Start date October 5, 2010
Completion date April 16, 2020
View Details
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