Clinical Trials Directory

Trials / Completed

CompletedNCT01219699

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

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
221 (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DRUGBYL719BYL719 is an oral α-specific phosphatidylinositol-3-kinase (PI3K) inhibitor.
DRUGFulvestrantIn adult patients with advanced solid malignancies whose tumors have an alteration (mutation or amplification) of the PIK3CA gene. Fulvestrant is an estrogen receptor antagonist, administered by monthly intramuscular injection

Timeline

Start date
2010-10-05
Primary completion
2015-02-05
Completion
2020-04-16
First posted
2010-10-13
Last updated
2020-09-22

Locations

11 sites across 5 countries: United States, Germany, Netherlands, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT01219699. Inclusion in this directory is not an endorsement.