Solid Neoplasm Clinical Trial
Official title:
Phase I Study of the Combination of the VEGFR Inhibitor, AZD2171, and MEK Inhibitor, AZD6244, in the Treatment of Solid Malignancies
This phase I trial studies the side effects and best dose of cediranib maleate and selumetinib 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.
PRIMARY OBJECTIVES:
I. To determine the maximally tolerated dose of AZD2171 (cediranib) (cediranib maleate) in
combination with AZD6244 hydrogen sulfate (selumetinib).
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 PO QD or
twice daily (BID) on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity. Courses may be extended to 12 weeks
after 1 year of study treatment.
After completion of study therapy, patients are followed up at 3 months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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