NCT05311579

Niraparib Plus Anlotinib for Recurrent Ovarian Cancer

Efficacy and Safety of Niraparib in Combination With Anlotinib Based on CA 125 Level in Newly Diagnosed Ovarian Cancer: A Open-label, Single Arm, Prospective Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Lei Li · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II trial to explore efficacy and safety of niraparib in combination with anlotinib based on CA 125 level in newly diagnosed ovarian cancer. After completion of 1st-line platinum-based chemotherapy with a normal CA-125 concentration, in patients with CA-125 increased \> 35U/ml, and with no evidence of imaging recurrence, niraparib and anlotinib are used as 1st maintenance therapy for newly diagnosed advanced ovarian cancer after achieving complete or partial remission to platinum-containing chemotherapy. The primary objective of this study is to explore the efficacy of niraparib combined with anlotinib based on CA 125 level in newly diagnosed ovarian cancer with no evidence of imaging recurrence. A total o f36 patients will be enrolled in this study.

Conditions

• Ovarian Carcinoma
• Survival Outcomes
• Adverse Events
• Niraparib
• Anlotinib
• CA125
• Chemotherapy
• Targeted Therapy
• Recurrent Ovarian Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Niraparib plus anlotinib	Niraparib QD D1-21 plus Anlotinib 10mg QD D1-14 until disease progression or intolerable toxicity 21days/cycle

Timeline

• Start date: 2022-03-27
• Primary completion: 2023-03-27
• Completion: 2024-03-27
• First posted: 2022-04-05
• Last updated: 2022-04-13

Locations

1 site across 1 country: China