Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Safety and Efficacy of RO4929097 in Combination With Temsirolimus: A Pharmacokinetic and Pharmacodynamic Phase I Study in Patients With Advanced Solid Tumours With an Expansion of Cohort With Patients With Recurrent/Metastatic Endometrial and Renal Cell Cancers
This phase I trial is studying the side effects and best dose of giving gamma-secretase/Notch signalling pathway inhibitor RO4929097 and temsirolimus together in treating patients with advanced solid tumors. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the recommended phase II dose (RP2D) and safety profile of temsirolimus in
combination with RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) in
patients with advanced solid tumors.
SECONDARY OBJECTIVES:
I. To obtain pharmacokinetic (PK) profiles for both drugs when administered in combination
in order to quantify the expected interactive effects in PK between these two agents.
II. To evaluate pharmacodynamic (PD) effects of both drugs when administered in combination,
with the goal of identifying potential predictive and PD markers that need further
exploration and validation in future trials.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive temsirolimus IV over 30 minutes on day -6 (course 1 only). Patients then
receive temsirolimus IV or orally (PO) on days 1, 8, and 15 and gamma-secretase/Notch
signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity. Blood
and tumor tissue samples may be collected periodically for pharmacokinetic and correlative
analyses.
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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