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Study With Afuresertib and Paclitaxel in Platinum Resistant Ovarian
Sponsor: Laekna Limited
Summary
Afuresertib is an AKT inhibitor, a new class of agents under development that may provide physicians with a new clinical option to control platinum resistant ovarian cancer (PROC) progression. Afuresertib plus chemotherapy has demonstrated anti-tumor efficacy and an acceptable safety profile in patients with PROC in a published Phase I/II study. Therefore, the combination of afuresertib plus weekly paclitaxel could represent a clinically meaningful step forward in the clinical management of these difficult-to-treat patients with PROC.
Official title: An Open Label Randomized Active Controlled Phase II Clinical Study to Assess the Efficacy and Safety of Afuresertib Plus Paclitaxel Versus Paclitaxel in Patients With Platinum-Resistant Ovarian Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2020-07-07
Completion Date
2024-06-28
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
Paclitaxel
Commercially available paclitaxel for IV administration will be obtained by clinical sites in US.
Afuresertib
Afuresertib tablet, intended for daily oral administration.
Locations (47)
Arizona Oncology Associates
Phoenix, Arizona, United States
Arizona Oncology
Tucson, Arizona, United States
Highlands Oncology Group
Rogers, Arkansas, United States
Gynecology Oncology Associates Newport Beach
Newport Beach, California, United States
Rocky Mountain Cancer Centers
Littleton, Colorado, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
University of Chicago
Chicago, Illinois, United States
Women's Cancer Care
Covington, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
MD Anderson Cancer Center at Cooper
Camden, New Jersey, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Southwest Women's Oncology Group
Albuquerque, New Mexico, United States
Montefiore Medical Center
The Bronx, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
OHCare Oncology Hematology Care (OHC), Inc. - Kenwood Office
Cincinnati, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Abington Memorial Hospital
Willow Grove, Pennsylvania, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Texas Oncology
Austin, Texas, United States
Texas Oncology
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
USO Texas Oncology
Longview, Texas, United States
US Texas Oncology
San Antonio, Texas, United States
Baylor Scott & White Medical Center
Temple, Texas, United States
Texas Oncology
The Woodlands, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, United States
Beijing Obstetrics & Gynecology Hospital, Capital Medical University
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Peking University Cancer Hospital
Beijing, China
Chongqing University Cancer Hospital
Chongqing, China
Sun Yat-sen University Cancer Center
Guangdong, China
Harbin Medical University Cancer Hospital
Heilongjiang, China
Henan Cancer Hospital
Henan, China
Hubei Cancer Hospital
Hubei, China
Hunan Cancer Hospital
Hunan, China
Jilin Cancer Hospital
Jilin City, China
Liaoning Cancer Hospital
Liaoyang, China
Qilu Hospital of Shandong University
Shandong, China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, China
Zhongshan Hospital affiliated to Fudan University
Shanghai, China
West China Second University Hospital,Sichuan University
Sichuan, China
The Second Hospital of Tianjin Medical University
Tianjin, China
Women's Hospital school of medicine Zhejiang University
Zhejiang, China