Spots Global Cancer Trial Database for Study With Afuresertib and Paclitaxel in Platinum Resistant Ovarian
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Trial Identification
Brief Title: Study With Afuresertib and Paclitaxel in Platinum Resistant Ovarian
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
Study ID: NCT04374630
Conditions
Study Description
Brief 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.
Detailed Description: A total of approximately 141 patients with PROC are planned to be enrolled and randomized with a 2:1 ratio in an open label manner to the 2 arms (94 patients in the combination treatment arm and 47 patients in the paclitaxel arm) for efficacy and safety evaluation. The randomization will be stratified by country (the United States vs. China), prior bevacizumab use (yes vs. no), and number of prior platinum based therapy treatments (1-2 vs. 3-5 prior platinum regimens). The study will consist of 3 periods. The first period is the Screening Period (Day -24 to 1) during which patients are screened for eligibility according to the inclusion and exclusion criteria. The second period is a Treatment Evaluation Period with a randomized, open-label, two arm parallel design (from starting study treatment until patients have progressive disease \[PD\], unacceptable toxicity, death, or withdrawal of consent). The PK study will be applied to both the combination treatment arm and control arm. The third period is a Follow up Period (safety evaluation at 30 days after the last dose of study treatment and OS and/or PFS follow up). Patients will be tested at baseline for phosphoinositide 3 kinase (PI3K)/AKT/PTEN pathway alterations and BRCA1/2 mutations by NGS, and/or level of phospho AKT by IHC; the correlation of the efficacy endpoints and biomarker status will be analyzed retrospectively as an exploratory endpoint.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, 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, , 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
Contact Details
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