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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05311579
Other study ID # NIRAN1
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 27, 2022
Est. completion date March 27, 2024

Study information

Verified date April 2022
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone 86-139-1198-8831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


Intervention

Combination Product:
Niraparib plus anlotinib
Niraparib QD D1-21 plus Anlotinib 10mg QD D1-14 until disease progression or intolerable toxicity 21days/cycle

Locations

Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival (PFS) Progression free survival (PFS) by RECIST v 1.1 24 months
Secondary Time to first subsequent therapy (TFST) Time to first subsequent therapy (TFST) 24 months
Secondary Overall survival (OS) Overall survival (OS) 48 months
Secondary Adverse events Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE) 24 months
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