Spots Global Cancer Trial Database for AZD1775 in Treating Patients With Advanced Refractory Solid Tumors With CCNE1 Amplification
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Trial Identification
Brief Title: AZD1775 in Treating Patients With Advanced Refractory Solid Tumors With CCNE1 Amplification
Official Title: A Phase 2 Study of AZD1775, a Wee1 Inhibitor, in Patients With CCNE1 Amplification
Study ID: NCT03253679
Interventions
Study Description
Brief Summary: This phase II trial studies how well AZD1775 works in treating patients with solid tumors with CCNE1 amplification that have spread to other places in the body (advanced) and do not respond to treatment (refractory). AZD1775 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVE: I. To evaluate the proportion of patients with the objective response rate (ORR) to adavosertib (AZD1775) in patients with advanced refractory cancers with CCNE1 amplification. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with AZD1775 in patients with advanced refractory cancers with CCNE1 amplification. II. To evaluate proportion of patients with extended time to progression (time to progression on AZD1775/ time to progression on last line of therapy \>= 1.3). III. To evaluate time until death or disease progression. IV. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms. OUTLINE: Patients receive adavosertib orally (PO) once daily (QD) on days 1-5 and 8-12. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center, Duarte, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
M D Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Siqing Fu
Affiliation: University of Texas MD Anderson Cancer Center LAO
Role: PRINCIPAL_INVESTIGATOR
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