Anlotinib and Niraparib Dual Therapy Evaluation in Platinum-resistant Recurrent Ovarian Cancer

Sponsor
Jihong Liu
Study ID
NCT04376073
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Niraparib 300mg(Body Weigh ≥77 kg)/200mg (Body Weigh \<77 kg) po QD day1\~21, Anlotinib 12mg po QD day1\~14
  • Anlotinib — DRUG
    Anlotinib 12mg po QD day1\~14. Starting dose of anlotinib changed to 10mg from 2020-11-13.

Study Details

At present, the standard treatment for platinum-resistant ovarian cancer patients is platinum-free chemotherapy, with poor efficacy and tolerance. The combination of anti-angiogenic drugs and PARPi can play a synergistic anti-tumor role and achieve good efficacy in platinum-sensitive recurrent ovarian cancer. This study intends to explore the safety and effectiveness of anlotinib and niraparib dual therapy in patients with platinum-resistant recurrent ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (ovarian cancer).

Key Dates

Start date
May 22, 2020
Status verified
Nov 2020
Primary completion
Dec 31, 2021
Completion
Mar 31, 2022

Study Design

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

Arms

  • Experimental: Treatment group
    Niraparib 300mg(Body Weigh ≥77 kg)/200mg (Body Weigh \<77 kg) po QD day1\~21, Anlotinib 12mg po QD day1\~14. Starting dose of anlotinib changed to 10mg from 2020-11-13.

Primary Outcome Measure

Objective Response Rate [ Time Frame: at 6 months ]

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