Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study of R04929097 in Combination With Gemcitabine in Patients With Advanced Solid Tumors
This phase I trial is studying the side effects and best dose of gamma-secretase inhibitor RO4929097 when given together with gemcitabine hydrochloride in treating patients with advanced solid tumors. Gamma-secretase inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gamma-secretase inhibitor RO4929097 together with gemcitabine hydrochloride may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the safety profile and establish the maximum-tolerated dose and recommended
phase II dose of gamma-secretase inhibitor RO4929097 in combination with gemcitabine
hydrochloride in patients with advanced solid tumors.
SECONDARY OBJECTIVES:
I. To determine the pharmacokinetic profile of gamma-secretase inhibitor RO4929097 when
given in combination with gemcitabine hydrochloride and to correlate the pharmacokinetic
profile with toxicity and biological activity.
II. To assess the antitumor activity of gamma-secretase inhibitor RO4929097 and gemcitabine
hydrochloride in patients with advanced solid tumors.
III. To correlate the expression of biomarkers of Notch signaling in archival tumor tissue
with antitumor activity of gamma-secretase inhibitor RO4929097 in combination with
gemcitabine hydrochloride.
OUTLINE: This is a multicenter, dose-escalation study of gamma-secretase inhibitor
RO4929097.
Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10,
15-17, and 22-24 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Plasma and blood samples may be collected periodically for pharmacokinetic studies and
biomarker analysis.
After completion of study treatment, patients are followed up every 1 month for up to 1
year.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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