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NCT05130515: CC-ANNIE

Anlotinib Combined With Niraparib Dual Therapy in Platinum-resistant Recurrent Ovarian Clear Cell Carcinoma.

Completed Phase 2 Last updated 31 January 2023
What this trial tests

Phase 2 trial testing Niraparib in Platinum-resistant Recurrent Clear Cell Ovarian Cancer in 6 participants. Completed in 1 January 2023.

Timeline
15 December 2021
Primary endpoint
1 January 2023
1 January 2023

Quick facts

Lead sponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment6
Start date15 December 2021
Primary completion1 January 2023
Estimated completion1 January 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Who can join

Adults 18 to 70, female only, with Platinum-resistant Recurrent Clear Cell Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Paradigm Shift: A Comprehensive Review of Ovarian Cancer Management in an Era of Advancements.
    Tavares V, Marques IS, Melo IG, Assis J, et al · · 2024 · cited 85× · PMID 38339123 · DOI 10.3390/ijms25031845
  2. Overcoming the challenges of drug development in platinum-resistant ovarian cancer.
    Eskander RN, Moore KN, Monk BJ, Herzog TJ, et al · · 2023 · cited 24× · PMID 37916177 · DOI 10.3389/fonc.2023.1258228
  3. Efficacy evaluation of multi-immunotherapy in ovarian cancer: From bench to bed.
    Hu X, Bian C, Zhao X, Yi T. · · 2022 · cited 19× · PMID 36275669 · DOI 10.3389/fimmu.2022.1034903
  4. Therapeutic Strategies Focused on Cancer-Associated Hypercoagulation for Ovarian Clear Cell Carcinoma.
    Tamura R, Yoshihara K, Enomoto T. · · 2022 · cited 13× · PMID 35565252 · DOI 10.3390/cancers14092125
  5. Remarkable Response to the Triplet Combination of Olaparib with Pembrolizumab and Bevacizumab in the Third-Line Treatment of an Ovarian Clear Cell Carcinoma Patient with an ARID1A Mutation: A Case Report.
    Zhao Y, Jiang Y. · · 2022 · cited 2× · PMID 35401005 · DOI 10.2147/ott.s362267

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