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COMPLETED
NCT04374630
PHASE2

Study With Afuresertib and Paclitaxel in Platinum Resistant Ovarian

Sponsor: Laekna Limited

View on ClinicalTrials.gov

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

Interventions

DRUG

Paclitaxel

Commercially available paclitaxel for IV administration will be obtained by clinical sites in US.

DRUG

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