294
Participants
Start Date
December 31, 2015
Primary Completion Date
October 31, 2024
Study Completion Date
December 31, 2024
AL3818
Taken daily from Day 8 to Day 21 (14 days),administered orally combination with one background chemotherapy in 21-day cycles.
Paclitaxel
"Weekly single agent Paclitaxel will be administered on Day 1, 8, and 15 of each 21-day cycle. Suggested dose: 80 mg/m\^2 intravenously or local standard.~Paclitaxel may also be administered once weekly with a 1-week break every 3 weeks in lieu of every week"
Pegylated Liposomal Doxorubicin (PLD)
"Single agent Pegylated Liposomal Doxorubicin (PLD) administered every 4 weeks on the following cycle days corresponding with AL3818 cycles until maximum cumulative dose per local standard reached.~Suggested dose: 40 mg/m\^2 intravenously or local standard"
Topotecan
Daily Topotecan on Days 1-5 of each 21-day cycle Suggested dose: 1.25 mg/m2 intravenously or local standard OR Weekly Topotecan with a 1 week break every 3 weeks. Suggested dose: 4 mg/m2 intravenously or local standard
Topotecan
Weekly Topotecan with a 1 week break every 3 weeks Suggested dose: 4 mg/m2 intravenously or local standard
Carboplatin
AUC 5/6 on Day 1 of each 21-Day cycles
Paclitaxel
175mg/m2 IV over 3 hours on Day 1 of each 21-Day cycle
AL3818
Taken daily from Day 8 to Day 21 (14 days). Administered orally.
Montefiore Medical Center, The Bronx
AHN West Penn Hospital, Pittsburgh
Hospital Universitario Ramón y Cajal, Madrid
Hospital Regional Universitario de Málaga, Málaga
HCU Virgen Arrixaca, Murcia
University of Miami Sylvester Comprehensive Cancer Center, Miami
Baptist Health Lexington Oncology Research, Lexington
Operative Unit of Oncology, Ravenna
"Romagnolo Institute For the Study of Tumors Dino Amadori", Meldola (FC)
University of Wisconsin Madison, Madison
Washington University, St Louis
UTSW, Dallas
The Oncology Institute of Hope and Innovation, Long Beach
The First Hospital of China Medical University, Shenyang
Henan Cancer Hospital, Hefei
Jilin Cancer Hospital, Changchun
Zhongda Hospital Southeast University, Chongqing
Tianjin Central Hospital of Gynecology Obstetrics, Tianjin
Obstetrics&Gynecology Hospital of Fudan University, Shanghai
Beijing Cancer Hospital, Beijing
Chongqing University Cancer Hospital, Chongqing
Weifang People's Hospital, Weifang
"National Cancer Institute IRCCS G. Pascale Foundation", Naples
University Hospital of Bologna-IRCCS, Bologna
Cannizzaro Emergency Hospital, Catania
Complex Structure Gynecology Oncology National Cancer Institute of Milan, Milan
Agostino Gemelli University Hospital Rome, Rome
Campus Bio Medico University Hospital Foundation, Rome
Korea University Guro Hospital, Seoul
Seoul National University Hospital, Seoul
Severance Hospital, Seoul
Hospital Universitario Reina Sofía, Córdoba
Hospital Clínico Universitario de Valencia, Valencia
Hospital Clínic de Barcelona, Barcelona
Hospital Clínico San Carlos, Madrid
Cambridge University Hospitals NHS Foundation Trust, Cambridge
The Royal Marsden NHS Foundation Trust, London
The Christie NHS Foundation Trust, Manchester
Samsung Medical Center, Seoul
ICO Badalona, Badalona
Hospital Universitari Vall d'Hebrón, Barcelona
Lead Sponsor
Advenchen Laboratories, LLC
INDUSTRY