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A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene
Bu çalışma, tümöründe PIK3CA gen değişikliği (mutasyon veya amplifikasyon) bulunan, standart tedavisi kalmamış ileri solid (katı) tümörlü hastalarda BYL719 (Alpelisib) ilacını inceliyor. Doğrulanmış PIK3CA durumu olan 18 yaş üstü hastalar dahil edilmiştir. Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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