Spots Global Cancer Trial Database for Onalespib and CDKI AT7519 in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
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Trial Identification
Brief Title: Onalespib and CDKI AT7519 in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
Official Title: A Phase 1 Trial of the Combination of the Heat Shock Protein-90 (HSP90) Inhibitor Onalespib (AT13387) and the Cyclin-Dependent Kinase (CDK) Inhibitor AT7519M in Patients With Advanced Solid Tumors
Study ID: NCT02503709
Study Description
Brief Summary: This phase I trial studies the side effects and best dose of onalespib and CDKI AT7519 in treating patients with solid tumors that have spread from the primary site (place where they started) to other places in the body (metastatic) or cannot be removed by surgery. Onalespib and CDKI AT7519 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. To establish the safety, tolerability, and the maximum tolerated dose of the combination of onalespib and AT7519M (CDKI AT7519). SECONDARY OBJECTIVES: I. To determine the pharmacokinetics of the combination of onalespib and AT7519M. II. To assess the pharmacodynamic effect of the combination of onalespib and AT7519M on HSP70 expression and modulation of HSP90 client proteins in peripheral blood mononuclear cells (PBMCs), plasma, and tumor biopsies. III. To observe and record anti-tumor activity. OUTLINE: This is a dose-escalation study. Patients receive onalespib intravenously (IV) over 1 hour on days 1 and 4 (cycle 0 only). Patients then receive onalespib IV over 1 hour and CDKI AT7519 IV over 1 hour on days 1, 4, 8, and 11 (cycle 1 and subsequent cycles thereafter). Cycles repeat every 21 days (7 days for course 0 only) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
National Cancer Institute Developmental Therapeutics Clinic, Bethesda, Maryland, United States
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Contact Details
Name: Khanh T Do
Affiliation: Dana-Farber - Harvard Cancer Center LAO
Role: PRINCIPAL_INVESTIGATOR
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