Spots Global Cancer Trial Database for Testing AZD1775 in Advanced Solid Tumors That Have a Mutation Called SETD2
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Trial Identification
Brief Title: Testing AZD1775 in Advanced Solid Tumors That Have a Mutation Called SETD2
Official Title: A Phase 2 Study of AZD1775 in SETD2-Deficient Advanced Solid Tumor Malignancies
Study ID: NCT03284385
Interventions
Study Description
Brief Summary: This phase II trial studies how well adavosertib works in treating patients with SETD2-deficient solid tumors that have spread to other places in the body (advanced/metastatic). Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria of adavosertib (AZD1775) in advanced solid tumor malignancies other than clear cell renal cell carcinoma with evidence of pathogenic loss of SETD2 using next-generation sequencing panel. II. To determine the objective response rate by RECIST 1.1 criteria of AZD1775 in clear cell renal cell carcinoma with evidence of loss of SETD2 using next-generation sequencing panel. SECONDARY OBJECTIVES: I. To determine the clinical benefit rate and duration of response of AZD1775 in SETD2-deficient tumors other than clear cell renal cell carcinoma. II. To determine the clinical benefit rate and duration of response of AZD1775 in SETD2-deficient clear cell renal cell carcinoma subgroup. III. To characterize the safety profile of AZD1775. IV. To determine whether H3K36me3 expression by immunohistochemical assay is associated with clinical outcomes. 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 30 days.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
UCSF Medical Center-Mission Bay, San Francisco, California, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, United States
University of Chicago Medicine-Orland Park, Orland Park, Illinois, United States
University of Kansas Clinical Research Center, Fairway, Kansas, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States
Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center-South County, Saint Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital, Saint Louis, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Vanderbilt Breast Center at One Hundred Oaks, Nashville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
M D Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Rahul R Aggarwal
Affiliation: Yale University Cancer Center LAO
Role: PRINCIPAL_INVESTIGATOR
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