Niraparib Plus Anlotinib for Recurrent Ovarian Cancer

Sponsor
Lei Li
Study ID
NCT05311579
Phase
PHASE2
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 27, 2022
Status verified
Apr 2022
Primary completion
Mar 27, 2023
Completion
Mar 27, 2024

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ovarian cancer patients with increased CA125
    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 Measure

Progression free survival (PFS) [ Time Frame: 24 months ]

Central Contacts

Related Studies