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A Study of BYL719 in Adult Patients With Advanced Solid Malignancies

Phase 1
18 Years
Open (Enrolling)
Advanced Solid Tumor

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Trial Information

A Study of BYL719 in Adult Patients With Advanced Solid Malignancies

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Time Frame:

4 Weeks

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

September 2011

Completion Date:

June 2014

Related Keywords:

  • Advanced Solid Tumor
  • Pi3K
  • Advanced solid tumor