Spots Global Cancer Trial Database for Cabozantinib-S-Malate and Vemurafenib in Treating Patients With Solid Tumors or Melanoma That is Metastatic or That Cannot Be Removed By Surgery

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Trial Identification

Brief Title: Cabozantinib-S-Malate and Vemurafenib in Treating Patients With Solid Tumors or Melanoma That is Metastatic or That Cannot Be Removed By Surgery

Official Title: Phase I Dose Escalation of the MET Inhibitor XL184 and the BRAF Inhibitor Vemurafenib

Study ID: NCT01835184

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

cabozantinib-s-malate

vemurafenib

laboratory biomarker analysis

pharmacological study

Study Description

Brief Summary: 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.

Detailed Description: 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.