Niraparib Plus Anlotinib for Recurrent Ovarian Cancer

Phase 2

• Conditions: Ovarian Carcinoma; Recurrent Ovarian Cancer; CA125; Survival Outcomes; Anlotinib; Targeted Therapy; Adverse Events; Niraparib; Chemotherapy
• Interventions: Combination Product: Niraparib plus anlotinib

• Registration Number: NCT05311579
• Lead Sponsor: Lei Li

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-27
• Study First Submitted: 2022-03-27
• Study First Submitted QC: 2022-03-27
• Status Verified: 2022-04
• Study First Posted: 2022-04-05
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-13
• Primary Completion: 2023-03-27
• Study Completion: 2024-03-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ovarian cancer patients with increased CA125	Niraparib plus anlotinib	Patients with CA125 \>35 U/ml or increased to 2 x nadir, and with no evidence of imaging recurrence after completion of 1st-line platinum-based chemotherapy

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	24 months	Progression free survival (PFS) by RECIST v 1.1

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	48 months	Overall survival (OS)
Adverse events	24 months	Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE)
Time to first subsequent therapy (TFST)	24 months	Time to first subsequent therapy (TFST)

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China