Impact of time of alpelisib administration, concomitant fasting and low carbohydrate diet on alpelisib toxicity and efficacy; a pilot randomized controlled phase IIb trial- ITACA

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• 1) Patient has history of hypersensitivity to any drugs or metabolites of PI3K inhibitor or any of the excipients of alpelisib. 2) Patient with established diagnosis of diabetes mellitus type I or uncontrolled type II. 3) Patient has a known history of Steven Johnson’s syndrome or toxic epidermal necrolysis. 4) Patient has a known history of Human Immunodeficiency Virus (HIV) infection. 5) Patient has had surgery within 14 days prior to starting program drug or has not recovered from major adverse reactions. 6) Patient has not recovered to grade 1 or better (except for alopecia) from related adverse reactions of prior antineoplastic therapies. 7) Patient has other prior or concurrent malignancy, with the exception of adequately treated basal or squamous cell skin cancer or other in situ cancer, or any other cancer from which the patient has been disease-free for ≥ 3 years. 8) Patient has central nervous system (CNS) involvement, except for patients fulfilling the following 3 criteria: - completed prior therapy (including radiation and/or surgery) for CNS metastases ≥ 28 days prior to the start of program treatment and - CNS tumor is clinically stable at the start of program treatment and - patient is not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases 9) Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of alpelisib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). 10) Patient who has other concurrent severe and/or uncontrolled medical conditions that would, in the Treating Physician’s judgment, contraindicate administration of alpelisib (e.g. active or uncontrolled severe infection, chronic active hepatitis, immunocompromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to enrolment, serious uncontrolled cardiac arrhythmia, symptomatic pericarditis, etc.). 11) Patient who is concurrently being treated with drugs known to be strong inhibitors or inducers of the isoenzyme CYP3A; switching to different medications prior to start of program treatment is allowed within the last 5 days prior to starting program treatment. 12) Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to start of program treatment, or who have not fully recovered from adverse reactions of such treatment. Note: The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular). 13) Male patient who does not apply highly effective contraception during the treatment with alpelisib and through the duration as defined below after the final dose of alpelisib. - Sexually active males should use a condom during intercourse while taking drug and for at least 4 weeks after stopping alpelisib and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.