Spots Global Cancer Trial Database for Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer
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Trial Identification
Brief Title: Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer
Official Title: A Phase II Evaluation of Copanlisib (BAY 80-6946), a Selective Inhibitor of PI3KCA, in Patients With Persistent or Recurrent Endometrial Carcinoma Harboring PIK3CA Hotspot Mutations
Study ID: NCT02728258
Study Description
Brief Summary: This phase II trial studies how well copanlisib works in treating patients with endometrial cancer that has not decreased or disappeared, and the cancer may still be in the body despite treatment (persistent) or has come back (recurrent). Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. To assess the activity of copanlisib (BAY 80-6946) in patients with persistent or recurrent endometrial carcinoma harboring phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PI3KCA) hotspot mutations with the frequency of objective response. SECONDARY OBJECTIVES: I. To estimate 6 month progression-free survival (PFS) and median PFS. II. To estimate the distribution of the duration of overall survival (OS). III. To assess the safety profile of copanlisib in endometrial cancer patients. TERTIARY OBJECTIVES: I. To systematically evaluate by sequencing the site (i.e., exome) and characteristics of PIK3CA mutations in endometrial cancer patients and correlate such mutations to overall response (OR), PFS, and OS in patients treated with copanlisib. OUTLINE: Patients receive copanlisib intravenously (IV) over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Yale University, New Haven, Connecticut, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler, Savannah, Georgia, United States
Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States
Cancer Care Center of O'Fallon, O'Fallon, Illinois, United States
Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States
Baystate Medical Center, Springfield, Massachusetts, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States
Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Southwest Gynecologic Oncology Associates Inc, Albuquerque, New Mexico, United States
Memorial Medical Center - Las Cruces, Las Cruces, New Mexico, United States
State University of New York Downstate Medical Center, Brooklyn, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
The Mark H Zangmeister Center, Columbus, Ohio, United States
ProMedica Flower Hospital, Sylvania, Ohio, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States
Legacy Good Samaritan Hospital and Medical Center, Portland, Oregon, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Parkland Memorial Hospital, Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
Marshfield Clinic Stevens Point Center, Stevens Point, Wisconsin, United States
Contact Details
Name: Alessandro D Santin
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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