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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Providence Hospital
Mobile, Alabama, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
University of Arizona Health Sciences Center
Tucson, Arizona, United States
Saint Edward Mercy Medical Center
Fort Smith, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Fremont - Rideout Cancer Center
Marysville, California, United States
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States
University of California at Davis Cancer Center
Sacramento, California, United States
Tahoe Forest Cancer Center
Truckee, California, United States
Start Date
October 1, 2010
Primary Completion Date
May 1, 2013
Completion Date
August 1, 2015
Last Updated
June 14, 2016
36
ACTUAL participants
gamma-secretase/Notch signalling pathway inhibitor RO4929097
DRUG
laboratory biomarker analysis
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT00577382
NCT00470470
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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