A Study of BYL719 in Adult Patients With Advanced Solid Malignancies

Novartis

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumor

Treatments

Drug: BYL719

Study type

Interventional

Funder types

Industry

Identifiers

NCT01387321

CBYL719X1101

Details and patient eligibility

About

In this study, BYL719 will be administered to adult patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will investigate the safety and tolerability and determine the MTD of BYL719 in Japanese patients.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with histologically-confirmed, advanced unresectable solid tumors Availability of a representative formalin fixed paraffin embedded tumor tissue sample
At least one measurable or non-measurable lesion Age ≥ 18 years
Eastern Cooperative Oncology Group(ECOG) Performance Status ≤ 2 Good organ (hepatic, kidney, BM) function at screening/baseline visit

Exclusion criteria

Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy and anti-epileptic therapy.
Prior treatment with PI3K inhibitor
Patient with peripheral neuropathy NCI-CTC Grade ≥ 2
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