Metastatic Malignant Solid Neoplasm Clinical Trial
Official title:
A Phase I/Ib Dose Escalation and Biomarker Study of Ceritinib (LDK378) in Combination With Everolimus in Patients With Locally Advanced or Metastatic Solid Tumors With an Expansion in NSCLC Characterized by Abnormalities in Anaplastic Lymphoma Kinase (ALK) Expression
This phase I trial studies the side effects and best dose of ceritinib and everolimus in treating patients with solid tumors that have spread from where they started to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic) or stage IIIB-IV non-small cell lung cancer. Ceritinib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose (MTD) of ceritinib (novel, potent and selective small molecule anaplastic lymphoma kinase [ALK] inhibitor) in combination with everolimus (a mammalian target of rapamycin [mTOR] inhibitor) in advanced cancers. SECONDARY OBJECTIVES: I. Preliminary descriptive assessment of the anti-tumor activity (response rate) of the combination in advanced non-small cell lung cancer (NSCLC) based upon Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. II. To determine the pharmacokinetics of ceritinib and everolimus used in combination. III. To determine the safety of ceritinib and everolimus used in combination. IV. To evaluate the toxicities and tolerability of the combinations. V. To document anti-tumor activity (disease control rate at 8 weeks and progression-free survival). EXPLORATORY OBJECTIVES: I. To explore baseline molecular markers that may predict clinical activity, and to explore pharmacodynamic markers in blood, tumor tissue and molecular imaging that may predict an increase in apoptosis and clinical activity. II. To determine concordance of ALK (protein levels on immunohistochemistry, fusion detection by fluorescence in situ hybridization [FISH] and somatic mutations). III. To determine ribosomal protein S6 kinase (S6K) phosphorylation as a measure of mTOR inhibition. OUTLINE: This is a dose-escalation study. Patients receive ceritinib orally (PO) once daily (QD) and everolimus PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 28 days. ;
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