Spots Global Cancer Trial Database for Phase 1/2a/3 Evaluation of Adding AL3818 to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma (AL3818-US-002)
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Trial Identification
Brief Title: Phase 1/2a/3 Evaluation of Adding AL3818 to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma (AL3818-US-002)
Official Title: A Phase 1/2a/3 Evaluation of the Safety and Efficacy of Adding AL3818 (Anlotinib, INN: Catequentinib), a Dual Receptor Tyrosine Kinase Inhibitor, to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma
Study ID: NCT02584478
Study Description
Brief Summary: This trial is a Phase 1b/2a/3 trial designed to evaluate the safety and efficacy of adding oral AL3818 (Anlotinib, INN: Catequentinib), a Dual Receptor Tyrosine Kinase Inhibitor, to standard platinum-based chemotherapy concurrently in Subjects with Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma.
Detailed Description: This trial is a Phase 1b/2a/3 trial designed to evaluate the safety and efficacy of adding oral AL3818(Anlotinib, INN: Catequentinib) to standard platinum-based chemotherapy concurrently and continued as a maintenance therapy for up to 12 months, in subjects with recurrent or metastatic endometrial, ovarian, fallopian, primary peritoneal, or cervical carcinoma. AL3818 is a novel small molecule dual receptor tyrosine kinase inhibitor, which shows highly selective inhibition of fibroblast growth factor receptor (FGFr) and vascular endothelial growth factor receptor (VEGFR). Preclinical studies of this agent in mouse models, including various cancer xenografts, have demonstrated that treatment of tumor-bearing mice with AL3818 induces tumor reductions. Phase 1 \& 2: This study is divided into two parts. The objective of Part 1 is the evaluation of the safety and tolerability of adding oral AL3818 to standard carboplatin plus paclitaxel chemotherapy for a cycle of 21 days to determine the recommended Phase II dose (RP2D). Phase 1 / Part 1 is now complete. Part 2-The objective of Part 2 is evaluation of preliminary efficacy and the safety of adding oral AL3818 at the RP2D determined in Part 1 to carboplatin and paclitaxel chemotherapy for 6 cycles. Continuous maintenance mono therapy with 14 days on and 7 days off regimen at the RP2D will be conducted up to 12 months and is extendable beyond until disease progression. Phase I is closed and Phase 2 is closed. Phase 3: This study is currently a Phase III, multi-center, randomized trial with active control designed to evaluate the efficacy and safety of AL3818 8 mg plus background treatment (Active Arm) vs background treatment alone (Control Arm), where three background treatments, weekly paclitaxel, pegylated liposomal doxorubicin (PLD), and topotecan are utilized. Oral AL3818 8 mg may be given concurrently with background treatment or alone if the background treatment must be discontinued due to its toxicity for up to 24 cycles of therapy, in subjects with recurrent or metastatic platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. Phase 3 is open.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
The Oncology Institute of Hope and Innovation, Long Beach, California, United States
University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Baptist Health Lexington Oncology Research, Lexington, Kentucky, United States
Washington University, Saint Louis, Missouri, United States
Montefiore Medical Center, Bronx, New York, United States
AHN West Penn Hospital, Pittsburgh, Pennsylvania, United States
UTSW, Dallas, Texas, United States
University of Wisconsin Madison, Madison, Wisconsin, United States
Henan Cancer Hospital, Hefei, Henan, China
Jilin Cancer Hospital, Changchun, Jilin, China
The First Hospital of China Medical University, Shenyang, Shenyang, China
Zhongda Hospital Southeast University, Chongqing, Sichuan, China
Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, Tianjin, China
Obstetrics&Gynecology Hospital of Fudan University, Shanghai, Yangpu District, China
Beijing Cancer Hospital, Beijing, , China
Chongqing University Cancer Hospital, Chongqing, , China
Weifang People's Hospital, Weifang, , China
National Cancer Institute IRCCS "G. Pascale" Foundation, Naples, Campania, Italy
University Hospital of Bologna-IRCCS, Bologna, Emilia-Romagna, Italy
Romagnolo Institute For the Study of Tumors "Dino Amadori", Meldola (FC), Forlì-Cesena, Italy
Cannizzaro Emergency Hospital, Catania, , Italy
Complex Structure Gynecology Oncology National Cancer Institute of Milan, Milan, , Italy
Operative Unit of Oncology, Ravenna, , Italy
Agostino Gemelli University Hospital Rome, Rome, , Italy
Campus Bio Medico University Hospital Foundation, Rome, , Italy
Severance Hospital, Seoul,, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Hospital Universitario Reina Sofía, Córdoba, Andalucía, Spain
Hospital Regional Universitario de Málaga, Malaga, Andalucía, Spain
ICO Badalona, Badalona, Catalunya, Spain
Hospital Universitari Vall d'Hebrón, Barcelona, Catalunya, Spain
Hospital Clínico Universitario de Valencia, Valencia, Comunidad Valenciana, Spain
Hospital Clínic de Barcelona, Barcelona, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
HCU Virgen Arrixaca, Murcia, , Spain
Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Name: Clinical Director
Affiliation: Advenchen Laboratories, LLC
Role: STUDY_DIRECTOR
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