Article Text

Download PDFPDF

180 An open-label randomized active-controlled phase ii clinical study to assess efficacy and safety of afuresertib plus paclitaxel versus paclitaxel in patients with platinum-resistant ovarian cancer
  1. Y Yue1,
  2. H Shen1,
  3. C Lu1,
  4. BN Hughes2,
  5. RL Coleman3,
  6. BJ Monk4 and
  7. TJ Herzog2
  1. 1Laekna, China
  2. 2University of Cincinnati Cancer Center, USA
  3. 3U.S. Oncology, USA
  4. 4Arizona Oncology, USA


Introduction Relapse of OC within 6 months after the last dose of platinum-based therapy is defined as platinum-resistant OC (PROC). Non-platinum therapies for PROC results in a progression-free survival (PFS) of 3.5–4 months and overall-response rate (ORR) of 10–20%. Therefore, developing new therapies for PROC remains an unmet medical need. Afuresertib (GSK2110183), a new oral, small-molecule pan-AKT kinase inhibitor, can reduce AKT activity in cancers and re-sensitize tumor cells to taxanes when used as a combination therapy. In addition, afuresertib plus chemotherapy has demonstrated anti-tumor efficacy (ORR 32% with mPFS of 7.1 months) with acceptable safety profiles. Therefore, the combination of afuresertib plus weekly paclitaxel warrants investigation in PROC.

Methods This is an open-label randomized active-controlled global phase II clinical study assessing the efficacy and safety of afuresertib (125 mg PO qD) plus paclitaxel (80 mg/M2 IV D1,8,15) q3W versus paclitaxel in PROC patients. Primary endpoint is PFS ( RECIST 1.1). Secondary endpoints include: OS, ORR, DOR, DCR, CA-125 response, etc. A total of 141 patients with PROC from both USA and China will be randomized 2:1 to combination and paclitaxel only arms, respectively. Inclusion criteria is histologic/cytologic confirmed high-grade serous, endometroid, or clear cell OC with 1 to 3 prior systemic therapies. Patients must either have received or be ineligible for prior bevacizumab and/or PARP inhibitor.

Results First patient was enrolled and dosed 7/7/2020 with planned study completion in mid-2022.

Conclusion/Implications New PROC afuresertib trial is now available for enrollment in US and China (NCT04374630).

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.