Status:
RECRUITING
Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer
Lead Sponsor:
Xing Xie
Conditions:
Efficacy and Safety
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Ovarian cancer is the leading cause of death from gynecologic tumors in the western world. Most patients have relapses, and responses to subsequent therapies are generally short-lived. Currently, the ...
Detailed Description
Ovarian cancer is the leading cause of death from gynecologic tumors in the western world. Most patients have relapses, and responses to subsequent therapies are generally short-lived. Currently, the ...
Eligibility Criteria
Inclusion
- 18-70years old;
- High grade (serous or endometrioid) epithelial ovarian cancers, fallopian tube or primary peritoneal carcinoma;
- Patients received at least two lines of platinum-containing chemotherapy, with recurrence occurring within six months after the last chemotherapy dose, or were platinum-refractory patients who have undergone at least two cycles of platinum-based chemotherapy;
- Measurable disease as per RECIST 1.1
- ECOG 0-2;
- Life expectancy ≥12 weeks;
- Confirmation of BRCA1/2 mutation status;
- PARPi naive;
- LVEF ≥ 50%;
- Bone Marrow Function: ANC：≥1.5×109/L； PLT：≥100×109/L；Hb: ≥90g/L;
- Liver and renal function:Serum creatinine ≤ normal upper limit (ULN) 1.5times; aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ULN 2.5times, or \<ULN 5times in the presence of liver metastasis; total bilirubin (TBil) level≤ ULN 1.5 times, or ≤ ULN 2.5times if Gilbert's syndrome are present;
- The childbearing age subjects must agree to take effective contraceptive measures during the trial; the serum or urine pregnancy test must be negative, non-lactating;
- Signed the informed consent;
Exclusion
- Prior treatment with PARP inhibitors except under specific conditions: 1. Patients who previously received PARP inhibitor (PARPi) therapy without disease progression during treatment, but discontinued due to reasons such as treatment cost or adherence issues; 2. Patients who received only one prior PARPi therapy (excluding fuzuloparib), with maintenance therapy lasting ≥ 12 months. In both cases, the time since the last PARPi treatment must be \>6 months prior to study enrollment;
- Patients who had previously received \>20% bone marrow radiotherapy in 1 week;
- Other malignant tumors have been found in the past 5 years,except for cured cervical carcinoma in situ, non melanoma of the skin;
- Uncontrolled systemic infection requiring anti-infective treatment;
- Allergies to the Fuzuloparib or Arsenic Trioxide or their excipients or intolerant patients;
- Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03;
- Researchers think it is not suitable for enrolling.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04518501
Start Date
July 1 2020
End Date
January 1 2025
Last Update
December 4 2024
Active Locations (1)
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1
Women's Hospital School Of Medicine Zhejiang University
Zhejiang, Hangzhou, China, 310006