Platinum-resistant Recurrent Clear Cell Ovarian Cancer Clinical Trial
Official title:
An Open-Label, Single Arm, Phase II Trial of Niraparib in Combination With Anlotinib in Patients With Platinum-Resistant Recurrent or Platinum-Refractory Clear Cell Ovarian Cancer.
According to the definition of National Comprehensive Cancer Network (NCCN), ovarian clear cell carcinoma (OCCC) is a less common subtype of epithelial ovarian cancer (EOC) . The preliminary trial ANNIE (NCT04376073) shows a promising efficacy and safety profile for the ANNIE combo (anlotinib+niraparib). There is limited progress in targeted therapy for those less common ovarian cancers. In this study (CC-ANNIE), we aim to evaluate the antitumor activity and safety of niraparib combined with anlotinib in patients with platinum-resistant or platinum-refractory OCCC.
The CC-ANNIE trial is a single-arm, single-center, exploratory phase II trial. Eligible patients (≥18 & ≤70 years) are histologically confirmed platinum-resistant recurrent OCCC and 20 subjects are planned to be enrolled. All subjects must have measurable lesions (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and are going to be treated with niraparib 200mg once daily, anlotinib 10mg on day 1-14 of each 21-day cycle thereafter until disease progression or intolerable toxicity. The primary endpoint is the objective response rate. ;