NCT01364051

Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies

Phase I Study of the Combination of the VEGFR Inhibitor, AZD2171, and MEK Inhibitor, AZD6244, in the Treatment of Solid Malignancies

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of cediranib maleate and selumetinib sulfate in treating patients with solid malignancies. Cediranib maleate and selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may also stop the growth of tumor cells by blocking blood flow to the tumor.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose of cediranib maleate (AZD2171 \[cediranib\]) in combination with selumetinib sulfate (AZD6244 hydrogen sulfate). II. To describe the toxicity profile associated with AZD2171 (cediranib) in combination with AZD6244 hydrogen sulfate. III. To describe the tumor responses and identify any activity of this AZD2171 (cediranib) in combination with AZD6244 hydrogen sulfate. IV. To explore, through correlative studies, the effect of AZD2171 (cediranib) with or without AZD6244 hydrogen sulfate on serum markers of apoptosis. V. To assess the pharmacokinetic interaction of AZD2171 (cediranib) in combination with AZD6244 hydrogen sulfate. VI. To study the association of clinical (toxicity and/or tumor response or activity) with the pharmacologic (pharmacokinetic/pharmacodynamic) parameters, and/or biologic (correlative laboratory study) results. OUTLINE: This is a dose-escalation study followed by a dose-expansion cohort study. Patients receive cediranib maleate orally (PO) once daily (QD) and selumetinib sulfate PO QD or twice daily (BID) on days 1-28 (days 8-28 of cycle 1). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cycles may be extended to 12 weeks after 1 year of study treatment. After completion of study therapy, patients are followed up at 3 months.

Conditions

• Metastatic Melanoma
• Refractory Malignant Solid Neoplasm
• Stage IV Cutaneous Melanoma AJCC v6 and v7
• Unresectable Malignant Solid Neoplasm

Interventions

Type	Name	Description
DRUG	Cediranib	Given PO
DRUG	Cediranib Maleate	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
DRUG	Selumetinib	Given PO
DRUG	Selumetinib Sulfate	Given PO

Timeline

• Start date: 2011-05-25
• Primary completion: 2019-06-06
• Completion: 2027-03-31
• First posted: 2011-06-02
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States