| Accession |
PRJCA018364 |
| Title |
Efficacy and Safety of Senaparib as Maintenance Treatment in Patients with Newly Diagnosed Advanced Ovarian Cancer (FLAMES Study): A Randomized, Double-blind, Placebo-controlled, Phase 3 Trial |
| Relevance |
Medical |
| Data types |
Targeted Locus (Loci)
|
| Organisms |
Homo sapiens
|
| Description |
Senaparib (IMP4297) is a novel, high potency PARP inhibitor. The phase 3 study FLAMES is to confirm the efficacy and safety of Senaparib as a single agent in Chinese patients with newly diagnosed advanced OC as 1L maintenance therapy. Eligible patients are those with high-grade serous or endometrioid tumors classified as stage III or IV, according to the International Federation of Gynecology and Obstetrics (FIGO) criteria, who have completed 1L platinum-based chemotherapy with complete response (CR) or partial response (PR). Patients were randomized to receive senaparib or placebo 100 mg/day orally on a 28-day cycle with 2:1 ratio until disease progression, unacceptable toxicity, or completion of 2 years of treatment. Patients were stratified by CR/PR and BRCA mutation positive/negative at baseline. Primary endpoint was progression-free survival (PFS) evaluated by blinded independent central review (BICR) according to RECIST v1.1. Secondary endpoints were progression-free survival (PFS) evaluated by investigators, overall survival (OS) and treatment emergent adverse events (TEAE). |
| Sample scope |
Multiisolate |
| Release date |
2024-04-30 |
| Grants |
| Agency |
program |
Grant ID |
Grant title |
| Impact Therapeutics(shanghai) ,Inc
|
|
N/A
|
|
|
|
| Submitter |
Chuyao
Zhang (zhangchy@sysucc.org.cn)
|
| Organization |
Sun Yat-sen University Cancer Center |
| Submission date |
2023-07-14 |
