A Study of Docetaxel for Injection (Albumin-bound) in Combination With Bevacizumab in Patients With Ovarian Cancer

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study ID
NCT05325229
Phase
PHASE2
Status
Unknown

Conditions

  • Platinum-resistant Recurrent Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 78 Years
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel for injection (Albumin-bound) — DRUG
    Docetaxel for injection (Albumin-bound), by intravenous infusion，75 mg/m\^2 or 100 mg/m\^2 once every 3 weeks.
  • Bevacizumab — DRUG
    Bevacizumab, by intravenous infusion, 15 mg/kg once every 3 weeks.

Study Details

This trial is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) combined with Bevacizumab and the pharmacokinetic characteristics of Docetaxel in patients with platinum-resistant recurrent ovarian cancer.

Key Dates

First listed
Apr 13, 2022
Start date
Aug 18, 2022
Status verified
Mar 2022
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

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

Arms

  • Experimental: Docetaxel combined with Bevacizumab
    Docetaxel for Injection (Albumin-bound) will be administrated once every 3 weeks at a dose of 75 mg/m\^2 or 100 mg/m\^2; Bevacizumab will be administrated once every 3 weeks at a dose of 15mg/kg.

Primary Outcome Measure

Dose escalation trial: Incidence of adverse event(AE) [ Time Frame: Up to approximately 2 years ]

Central Contacts