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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

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

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

Keywords

Advanced Solid Tumors With an Alteration of the PIK3CA Gene Estrogen Receptor Positive Breast Cancer advanced solid tumors mutation amplification wild type PIK3CA gene dose-escalation Estrogens Estradiol Fulvestrant

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit Only patients who have confirmed PIK3CA status (wild type, mutation or amplification) will be allowed for screening (patients participating in the combination arm must be eligible for treatment with fulvestrant)
  • Availability of a representative formalin fixed paraffin embedded tumor tissue sample
  • At least one measurable or non-measurable lesion
  • Age ≥ 18 years
  • World Health Organization (WHO) Performance Status ≤ 2
  • Good organ (hepatic, kidney, BM) function at screening/baseline visit

You CAN'T join if...

  • Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy (anti-epileptic therapy is allowed).
  • Prior treatment with PI3K, AKT or mTOR inhibitor and failure to benefit
  • Patient with peripheral neuropathy NCI-CTC Grade ≥ 3
  • Patient with diarrhea NCI-CTC Grade ≥ 2
  • Patient with acute or chronic pancreatitis
  • Impaired cardiac function or clinically significant cardiac disease incl. unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug.
  • Patients with clinically manifest diabetes mellitus, history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus
  • Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control

    Other protocol-defined inclusion/exclusion criteria may apply

Locations

  • MD Anderson Cancer Center/University of Texas MD Anderson
    Houston, Texas, 77030-4009, United States
  • Vanderbilt Univeristy SC
    Nashville, Tennessee, 37232, United States
  • Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(4)
    Nashville, Tennessee, 37203, United States
  • Massachusetts General Hospital Mass General / HMS
    Boston, Massachusetts, 02114, United States
  • Novartis Investigative Site
    Oxford, OX3 7LJ, United Kingdom
  • Novartis Investigative Site
    Amsterdam, 1066 CX, Netherlands
  • Novartis Investigative Site
    Essen, 45147, Germany
  • Novartis Investigative Site
    Würzburg, 97080, Germany
  • Novartis Investigative Site
    Barcelona, Catalunya, 08035, Spain
  • Novartis Investigative Site
    Hospitalet de LLobregat, Catalunya, 08907, Spain

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT01219699
Phase
Phase 1
Lead Scientist
Hope Rugo
Study Type
Interventional
Last Updated
March 1, 2017