Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 may not be 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
