Abstract
ObjectivesAL 3818 is a novel, orally administered, small molecule tyrosine kinase inhibitor, that shows highly selective inhibition of fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR). The primary objective of this Phase 3 study is to evaluate the efficacy of AL3818 in combination with chemotherapy in patients with platinum resistant and refractory ovarian carcinoma.MethodsThe study is a phase 3, multi-center, randomized trial at 1:1 ratio with active control designed to evaluate the efficacy and safety of AL3818 plus background chemotherapy treatment (Active Arm) vs. background chemotherapy treatment alone (Control Arm), where one of three background treatments, weekly paclitaxel, pegylated liposomal doxorubicin (PLD), or topotecan is utilized. Patients with a diagnosis of platinum resistant or platinum refractory ovarian carcinoma requiring third line, or any further line treatment are eligible for enrollment. The regimen is a 21-day cycle with oral AL3818 at 8 mg administered on days 8–21, with days 1–7 off combining with one of the three chemotherapies in Active Arm. Maintenance monotherapy with AL3818 is an option if chemotherapy is discontinued. The primary objective of this study is to evaluate the efficacy between the Active Arm and Control Arm as measured by the primary endpoint of Progression Free Survival (PFS). The study is opening in US, UK, ES, IT and Asia. Clinical trial information: NCT02584478.ResultsThere are no available results at the time of submission.ConclusionsThere are no available results at the time of submission.
