Stage IV Breast Cancer Clinical Trial
Official title:
A Phase 1, Pharmacokinetic and Pharmacodynamic Study of the Combination of RO4929097 and Cediranib in Patients With Advanced Solid Tumors
This phase I clinical trial is studying the side effects and best dose of giving gamma-secretase inhibitor RO4929097 and cediranib maleate together in treating patients with advanced solid tumors. Gamma-secretase inhibitor RO4929097 and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate also may stop the growth of tumor cells by blocking blood flow to the tumor.
PRIMARY OBJECTIVES:
I. To determine the tolerability, maximum tolerated dose (equivalent to the recommended
phase II dose), and safety profile of RO4929097 (gamma-secretase inhibitor RO4929097) in
combination with cediranib (cediranib maleate) in patients with advanced malignancies.
SECONDARY OBJECTIVES:
I. To obtain pharmacokinetic (PK) profiles for RO4929097 when administered alone and for
RO492907 and cediranib in combination, in order to evaluate for interactive effects in PK
(if any) between these two agents.
II. To evaluate pharmacodynamic (PD) effects of RO492907 when administered alone and in
combination, with the goal of identifying potential predictive and PD markers that need
further exploration and validation in future trials.
III. To assess for preliminary antitumor efficacy of this drug combination, especially in
breast cancer, malignant melanoma, colorectal cancer, pancreatic cancer, kidney cancer, high
grade glioma, non-small-cell lung cancer, and ovarian cancer.
OUTLINE: This is a dose-escalation study.
Patients receive gamma-secretase inhibitor RO4929097 orally (PO) once daily (QD) on days
1-3, 8-10, and 15-17 (days 1-3, 8-10, 15-17 22-24, 29-31, and 36-38 of course 1) and
cediranib maleate PO QD on days 1-21 (days 22-42 course 1 only). Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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