Actively Recruiting
Fuzuloparib Plus Arsenic Trioxide in Platinum-Resistant Relapsed Ovarian Cancer
Led by Xing Xie · Updated on 2024-12-04
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Ovarian cancer is a leading cause of death among gynecologic tumors, with many patients experiencing relapses and limited response durations to current treatments. This research aims to evaluate the effectiveness and safety of combining Fuzuloparib with Arsenic trioxide therapy in patients who have relapsed with platinum-resistant ovarian cancer. The study focuses on patients who have already undergone at least two platinum-based chemotherapy treatments and seeks to improve outcomes in those with homologous recombination proficiency who currently have low response rates to PARP inhibitor therapy. Participants will receive a combination of Fuzuloparib capsules and Arsenic trioxide tablets. Arsenic trioxide is taken orally at a dose of 0.27 mg nine times daily for 21 consecutive days followed by a one-week rest, while Fuzuloparib capsules are taken twice daily at 150 mg. This combination treatment is based on preclinical studies showing stronger tumor cell growth inhibition and increased cancer cell death compared to either drug alone. The study is conducted in phases 1 and 2 to assess this combined therapy's potential benefits and safety. During the study, participants will be monitored for tumor response, progression-free survival, overall survival, and quality of life over up to 36 months. Safety will be assessed by tracking adverse reactions throughout treatment and up to 30 days after the last chemotherapy cycle. Quality of life is evaluated at baseline and before each new chemotherapy cycle up to six cycles. Researchers will use imaging and laboratory tests to measure tumor size and health status, ensuring close observation of treatment effects and participant well-being.
CONDITIONS
Brief Title
Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Diagnosis of high-grade (serous or endometrioid) epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
- Received at least two lines of platinum-containing chemotherapy with recurrence within six months after last dose or platinum-refractory after at least two cycles
- Presence of measurable disease according to RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 12 weeks
- Confirmed BRCA1/2 mutation status
- No prior treatment with PARP inhibitors
- Left ventricular ejection fraction (LVEF) of 50% or higher
- Adequate bone marrow function: absolute neutrophil count ≥1.5 × 10⁹/L, platelets ≥100 × 10⁹/L, hemoglobin ≥90 g/L
- Adequate liver and kidney function as defined by specified laboratory limits
- Women of childbearing potential must use effective contraception and have a negative pregnancy test
- Signed informed consent
You will not qualify if you...
- Prior PARP inhibitor treatment except in specific situations with no disease progression and treatment stopped over 6 months ago
- More than 20% bone marrow radiotherapy within one week
- Other malignant tumors in past 5 years except cured cervical carcinoma in situ or non-melanoma skin cancer
- Uncontrolled systemic infections requiring treatment
- Allergy or intolerance to Fuzuloparib, Arsenic trioxide, or their components
- Peripheral neuropathy grade 2 or higher
- Investigator judgment that participation is unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles with 1 week rest, up to 6 cycles
Participants receive combination therapy with Fuzuloparib Capsules and Arsenic trioxide Tablets to treat platinum-resistant relapsed ovarian cancer.
Visits on the first day of every two chemotherapy cycles and regular assessments during treatment
Duration - Up to 36 months
Participants are monitored for adverse reactions, disease progression, and quality of life after treatment ends.
Periodic visits for assessments up to 36 months
Trial Site Locations
Total: 1 location
1
Women's Hospital School Of Medicine Zhejiang University
Zhejiang, Hangzhou, China, 310006
Actively Recruiting
Research Team
Y
yuanming shen, PhD
X
xing xie, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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