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Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors

2014-08-27 03:13:22 | BioPortfolio

Summary

RATIONALE: 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.

PURPOSE: 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.

Description

OBJECTIVES:

Primary

- To determine the tolerability, maximum-tolerated dose (equivalent to the recommended phase II dose), and safety profile of gamma-secretase inhibitory RO4929097 in combination with cediranib maleate in patients with advanced solid tumors.

Secondary

- To obtain pharmacokinetic profiles for both drugs when administered in combination, as well as on their own, in order to evaluate for interactive effects in pharmacokinetics (if any) between these two agents.

- To evaluate the pharmacodynamic effects of both drugs when administered alone and in combination, with the goal of identifying potential predictive and pharmacodynamic markers that need further exploration and validation in future trials.

- 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 oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17 and oral cediranib maleate once daily on days 1-21 (beginning in course 2). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Blood and tissue samples may be collected periodically for pharmacokinetic, pharmacodynamic, and other laboratory studies.

After completion of study treatment, patients are followed up for 4 weeks.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Brain and Central Nervous System Tumors

Intervention

cediranib maleate, gamma-secretase inhibitor RO4929097, laboratory biomarker analysis, pharmacological study

Location

Margaret and Charles Juravinski Cancer Centre
Hamilton
Ontario
Canada
L8V 5C2

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:22-0400

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