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

Conditions

• Platinum-resistant Recurrent Clear Cell Ovarian Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Niraparib — DRUG
  Niraparib 200mg po QD, day1\~21
• Anlotinib — DRUG
  Anlotinib 10mg po QD, day1\~14, 3 weeks/cycle

Study Details

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.

Key Dates

Start date

Dec 15, 2021

Status verified

Nov 2022

Primary completion

Jan 1, 2023

Completion

Jan 1, 2023

Study Design

Enrollment

6 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment group
  Niraparib 200mg po QD day1\~21, Anlotinib 10mg po QD day1\~14

Primary Outcome Measure

Objective response rate [ Time Frame: at 6 months ]