Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase 1 Study of RO4929097 (NSC749225) in Combination With Capecitabine in Refractory Solid Tumors
This phase I clinical trial is studying the side effects and best dose of RO4929097 when given together with capecitabine in treating patients with refractory solid tumors. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving RO4929097 together with chemotherapy may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of RO4929097 and capecitabine administered
in subjects with advanced solid tumors. (Part 1) II. To describe the dose-limiting
toxicities (DLTs) of combined RO492097 and capecitabine. (Part 1) III. To determine the
safety of RO4929097 and capecitabine administered in combination. (Part 1) IV. To determine
the safety of RO4929097 and capecitabine in subjects with metastatic CRC. (Part 2a) V. To
evaluate the safety of RO4929097 and capecitabine in combination for subjects with HER2/neu
negative MBC. (Part 2b)
SECONDARY OBJECTIVES:
I. To determine the clinical activity of RO4929097 and capecitabine administered in
combination to subjects with advanced solid tumors. (Parts 1, 2a, and 2b) II. To evaluate
the changes in the expression of Notch1 signaling pathway members and downstream targets of
Notch by PCR including HEs1, 3 and 5; Hey 1 and 2 after treatment with RO4929097 at the MTD
expansion cohorts. (Parts 1, 2a, and 2b) III. To determine the pharmacokinetic and
pharmacogenomic profiles of the combination of RO4929097 and capecitabine. (Parts 1, 2a, and
2b) IV. To determine the progression-free survival (PFS) of RO4929097 and capecitabine when
administered at the MTD level in patients with metastatic colorectal cancer (CRC) and a
history of 1 or 2 prior therapies. (Part 2a) V. To determine the response and overall
survival (OS) rates following RO4929097 and capecitabine administration at the MTD level in
subjects with metastatic CRC. (Part 2a) VI. To determine the overall response rate (ORR) of
RO4929097 and capecitabine when administered at the MTD level to subjects when administered
first or second line for HER2/neu negative metastatic breast cancer (MBC). (Part 2b) V. To
determine the progression-free and overall survival rates following RO4929097 and
capecitabine administration at the MTD level in subjects with HER2/neu negative MBC. (Part
2b)
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, and
15-17 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
Patients may undergo tumor biopsy before and after treatment for biomarker analysis and
blood sample collection periodically for pharmacokinetic and pharmacogenomic studies.
After completion of study treatment, patients are followed up for 30 days (Part 1) or every
3 months (Parts 2a and 2b).
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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