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

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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