Adult Solid Neoplasm Clinical Trial
Official title:
A Phase I, Single-Institution Open Label, Dose-Escalation Trial With an Expansion Trial Cohort Evaluating the Safety and Tolerability of AZD6244 and IMC-A12 in Subjects With Advanced Solid Malignancies
This phase I clinical trial studies the safety and best dose of selumetinib and cixutumumab in treating patients with advanced solid malignancies. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry [cancer/tumor]-killing substances to them.
PRIMARY OBJECTIVES:
I. Determine the safety and toxicity of the combination of AZD6244 and IMC-A12 in advanced
solid tumors that have progressed on standard therapy.
II. Finding the maximum tolerated dose (MTD)/recommended phase II dose of the combination.
SECONDARY OBJECTIVES:
I. Explore preliminary evidence of efficacy of the combination of AZD6244 and IMC-A12 in
advanced solid tumors using RECIST criteria for tumor response.
II. Define pharmacodynamic (PD) profile of the combination of IMC-A12 and AZD6244.
III. Correlate pharmacokinetics (PK) of the combination of IMC-A12 and AZD6244 to
pharmacodynamic (PD) endpoints.
IV. Assess the PK/PD (phospho-S6) link with AZD6244 when administered in combination with
IMC-A12.
OUTLINE: This is a dose-escalation study of selumetinib and cixutumumab.
Patients receive selumetinib orally (PO) twice daily (BID) on days 1-28 and cixutumumab
intravenously (IV) on days 1 and 15. 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.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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