Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I Dose Escalation of the MET Inhibitor XL184 and the BRAF Inhibitor Vemurafenib
This phase I trial studies the side effects and best dose of cabozantinib-s-malate when given together with vemurafenib in treating patients with solid tumors or melanoma that is metastatic or that cannot be removed by surgery. Cabozantinib-s-malate and vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine a tolerable dose of XL184 (cabozantinib-s-malate) in combination with
vemurafenib.
SECONDARY OBJECTIVES:
I. To determine the objective response rate (ORR) and disease control rate (DCR) per
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
II. To determine the progression-free survival (PFS). III. To determine the response rate
according to the molecular phenotype.
OUTLINE: This is a dose-escalation study of cabozantinib-s-malate.
Patients receive cabozantinib-s-malate orally (PO) once daily (QD) and vemurafenib PO twice
daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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