Spots Global Cancer Trial Database for A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors, Colorectal, and Breast Cancer
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Trial Identification
Brief Title: A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors, Colorectal, and Breast Cancer
Official Title: A Multi-Center, Open-Label, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anticancer Activity of Fruquintinib in Patients With Advanced Solid Tumors
Study ID: NCT03251378
Interventions
Study Description
Brief Summary: An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors, metastatic colorectal cancer and metastatic breast cancer.
Detailed Description: The study is an open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors. The study will consist of two phases: * A dose escalation phase - A 3+3 design will be used for this portion of the study. * A dose expansion phase - Five cohorts will be evaluated in Dose Expansion. Cohort A will evaluate the MTD/RP2D in patients with advanced solid tumors. Cohort B and Cohort C will evaluate the MTD/RP2D in metastatic colorectal cancer patients. Cohort D and Cohort E will evaluate the MTD/RP2D in metastatic breast cancer patients. Study will be conducted in up to 9 sites in the US.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Arizona, Phoenix, Arizona, United States
California Cancer Care Associates for Research & Excellence, Inc., San Marcos, California, United States
St. Joseph Heritage Healthcare, Santa Rosa, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Hem-Onc Associates of the Treasure Coast, Port Saint Lucie, Florida, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: William Schelman
Affiliation: HUTCHMED International
Role: STUDY_DIRECTOR
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