Trial Title:
Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer
NCT ID:
NCT06539091
Condition:
Epithelial Ovarian Cancer
Efficacy
Safety
Bone Mineral Density
Tolerability
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Apatinib
Fluzoparib
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fluzoparib
Description:
The study treatment was followed by a 3-week treatment cycle. First day of each dosing
cycle, subjects are required to complete various examinations, including vital signs,
physical examination, laboratory examination, physical status score, and BMD testing to
evaluate the safety and tolerability of continued treatment.
Arm group label:
Fluzoparib group
Intervention type:
Drug
Intervention name:
Apatinib Mesylate
Description:
The study treatment was followed by a 3-week treatment cycle. First day of each dosing
cycle, subjects are also required to complete various examinations, including vital
signs, physical examination, laboratory examination, physical status score, and BMD
testing to evaluate the safety and tolerability of continued treatment.
Arm group label:
Apatinib Mesylate group
Summary:
This study is a single-arm, open, multicenter, exploratory clinical study to observe and
evaluate the efficacy and safety of fluazoparib combined with apatinib mesylate in the
treatment of patients with ovarian cancer.
Patients with epithelial ovarian, fallopian tube, and primary peritoneal cancers will be
selected as the study population with Progression-Free Survival (PFS) as the primary
study endpoint, and Overall Survival (OS), Duration Of Response (DOR), Quality of Life
Score QoL, Chemotherapy-Free Interval (CFI), Progression-Free Survival 2 (PFS-2), CA125
response criteria by GCGI, to access the safety、Bone Mineral Density (BMD) changes and
the tolerability of fluazoparib in combination with apatinib mesylate.
The study is planned to enroll 51 subjects, all of whom will receive study treatment
after being signed informed and screened.
Detailed description:
During the treatment period, subjects were given fluazoparib capsules orally, two
capsules/dose (50mg/capsule) twice daily, taken orally in the morning and in the evening,
as a continuous dosage. Subjects will also receive oral apatinib mesylate tablets, one
tablet/dose (250 mg/tablet), once daily, continuously. Treatment will continue until an
event occurs that meets the criteria for discontinuation of treatment.
Safety evaluations will be performed on Day 1 of each 3-week treatment cycle (vital
signs, physical examination, laboratory examination, physical status score and BMD
testing); imaging evaluations and once CA125 test will be performed every 6 weeks for the
first 24 weeks of dosing, and every 9 weeks thereafter to assess efficacy, and for 12
months or until an event occurs that meets the criteria for treatment discontinuation.
Dose suspension or downward adjustment may be made during the study period based on the
occurrence of adverse events in subjects.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ECOG PS: 0-1;
- Initially treated patients with histologically or cytologically confirmed
high-grade plasma ovarian cancer (HGSOC), fallopian tube cancer, primary
peritoneal cancer, or endometrioid carcinoma of the ovary with FIGO stage
III-IV;
- No prior maintenance therapy with PARP inhibitors; ④Final use of a
combination chemotherapy regimen of bevacizumab, paclitaxel and
carboplatin; ⑤Good function of major organs; ⑥Subjects voluntarily
enrolled in this study, signed an informed consent form, had good
compliance, and cooperated with follow-up visits; ⑦The modeled CA-125
ELIMination rate constant K (KELIM) ≥ 1.
Exclusion Criteria:
- Patients concurrently enrolled in other clinical trials;
- Previous maintenance therapy with PARP inhibitors combined with anti-angiogenic
drugs;
- Previous history of allergic reaction, hypersensitivity reaction,
intolerance to antibody-based drugs;
- Previous significant allergy to drugs or food or other substances;
- Subjects with untreated CNS metastases, previously treated with
systemic, radical brain or meningeal metastases (radiotherapy or
surgery), may be included if imaging confirms that stabilization
has been maintained for at least 1 month and systemic hormone
therapy (dose >10mg/day prednisone or other isotonic hormones)
has been discontinued for >2 weeks without clinical evidence;
- Those who are unable to swallow tablets normally, or have
abnormal gastrointestinal function that, in the judgment of
the investigator, may interfere with drug absorption;
- Have experienced clinically significant bleeding
symptoms or have a clear bleeding tendency within 3
months prior to randomization, such as peptic
bleeding, bleeding gastric ulcer or suffering from
vasculitis, etc. If the fecal occult blood is positive
at the baseline period, it can be reviewed, and if it
is still positive after review, combined with the
clinical judgment, and if necessary, gastroscopy can
be performed; ⑧The presence of currently uncontrolled
malignant pleural fluid, ascites or pericardial
effusion (defined as not effectively controlled by
diuretics or puncture, as judged by the investigator);
- Presence of uncontrolled comorbidities including,
but not limited to: active HBV or HCV infection,
known HIV infection or history of AIDS, active
syphilis, active tuberculosis, active infections,
uncontrolled hypertension, symptomatic cardiac
insufficiency, and active bleeding;
- Previous (within 5 years) or concurrent
other untreated malignant tumors, except for
cured basal cell carcinoma of the skin,
carcinoma in situ of the cervix, and breast
cancer without recurrence > 3 years after
completion of radical surgery; ⑪Women during
pregnancy or lactation; ⑫Having taken a drug
that clearly affects the study drug within
30 days or 5 half-lives (whichever is
longer) prior to enrollment; ⑬In the
judgment of the investigator, the subject
has other factors that may cause this study
to be forcibly terminated midway, such as
other serious illnesses (including
psychiatric illnesses) that require comorbid
treatment, serious laboratory test
abnormalities, accompanied by family or
social factors that would affect the
subject's safety, or the collection of data
and samples.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
October 1, 2024
Completion date:
October 1, 2026
Lead sponsor:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Source:
Anhui Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06539091
