Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.
Platinum-resistant Recurrent Clear Cell Ovarian Cancer
absolute
Anlotinib
Phase 2
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.}}
Study Type : | Interventional |
Estimated Enrollment : | 6 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
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. |
Actual Study Start Date : | December 15, 2021 |
Estimated Primary Completion Date : | January 1, 2023 |
Estimated Study Completion Date : | January 1, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment group Niraparib 200mg po QD day1~21, Anlotinib 10mg po QD day1~14 |
Drug: Niraparib Drug: Anlotinib |
Ages Eligible for Study: | 18 Years to 70 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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Not yet recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000