Recurrent Melanoma Clinical Trial
Official title:
Phase II Study of RO4929097 (NSC-749225) in Advanced Melanoma
This phase II trial is studying how well gamma-secretase/Notch signalling pathway inhibitor RO4929097 works in treating patients with stage IV melanoma. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To assess the six-month progression-free survival and one-year overall survival
probability in Stage IV melanoma patients treated with RO4929097 (gamma-secretase/Notch
signalling pathway inhibitor RO4929097).
SECONDARY OBJECTIVES:
I. To investigate in a preliminary manner the relationship between Notch activation status
and gene expression profile of tumor and clinical outcomes from patients in this study.
II. To study the effects of the investigational therapy on T cell function, which will
provide a basis for subsequent trials combining Notch blockade with immunomodulatory therapy
for advanced melanoma.
III. To assess the response rate (confirmed and unconfirmed complete and partial responses).
IV. To assess toxicity.
OUTLINE: This is a multicenter study.
Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 orally (PO) on
days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.
Some patients undergo blood collection at baseline and during study for analysis of T-cell
function by flow cytometry and ELISA. Tumor tissue samples from biopsy or surgery are also
analyzed for Notch activation by IHC and qRT-PCR.
After completion of study therapy, patients are followed up every 3 months for 1 year and
then every 6 months for 2 years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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