NCT01061749

Selumetinib and Cixutumumab in Treating Patients With Advanced Solid Malignancies

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adult Solid Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	Cixutumumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
DRUG	Selumetinib	Given PO

Timeline

• Start date: 2009-11-01
• Primary completion: 2013-04-01
• Completion: 2014-09-01
• First posted: 2010-02-03
• Last updated: 2016-01-25

Locations

1 site across 1 country: United States