Metastatic Malignant Solid Neoplasm Clinical Trial
Official title:
A Phase I/II Open-Label Study of Alpelisib (BYL719) in Combination With Carboplatin in Patients With Solid Tumors and HPV+ Squamous Cell Carcinoma
This phase I/II trial tests the safety, side effects, and best dose of alpelisib and whether alpelisib and carboplatin work to shrink tumors in patients with solid tumors or human papillomavirus (HPV) positive squamous cell carcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Alpelisib belongs to a group of medicines called phosphatidylinositol 3-kinase (PI3K) inhibitors. This means alpelisib blocks the activity of the PI3K protein. The PI3K pathway is well known to be involved in tumor cell multiplication and survival. Blocking PI3K may reduce the ability of certain cancers to grow. Carboplatin is an anticancer drug or chemotherapy drug that binds to DNA causing damage that prevents the DNA from replicating, which prevents the cells itself from reproducing. Giving alpelisib and carboplatin may help control the disease in patients with solid tumors and HPV positive squamous cell carcinoma.
PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose and recommended phase 2 dose of alpelisib in combination with carboplatin. II. To characterize the safety profile of the combination of alpelisib and carboplatin. III. To determine the overall response rate with the treatment combination in HPV+ solid tumor malignancies (dose expansion). SECONDARY OBJECTIVES: I. To determine the median progression-free survival with the treatment combination in HPV+ solid tumor malignancies. II. To characterize the glycemic impact of the combination of alpelisib and carboplatin. EXPLORATORY (CORRELATIVE) OBJECTIVES: I. To investigate the relationship between hyperpolarized carbon-13 with PI3K pathway modulation serially in real time. II. To measure the prevalence of PIK3CA mutations in the study population. OUTLINE: This is a phase I, dose-escalation study of alpelisib followed by a phase II dose expansion study. Patients receive alpelisib orally (PO) once daily (QD) on days 1-21 and carboplatin intravenously (IV) on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days. ;
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