Combining Fuzuloparib and Arsenic Trioxide for Ovarian Cancer Treatment

Fuzuloparib Plus Arsenic Trioxide in Patients With Platinum Resistance Relapsed Ovarian Cancer

This study is testing a new combination of two drugs, Fuzuloparib and Arsenic trioxide, to see if it can help people with ovarian cancer who haven't responded to other treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Women's Hospital School Of Medicine Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Zhejiang, Hangzhou)
• Trial ID: NCT04518501 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of Fuzuloparib in combination with Arsenic trioxide for patients with platinum-resistant relapsed ovarian cancer. The study aims to improve outcomes for patients who have already undergone multiple lines of platinum-based chemotherapy and have limited treatment options. The methodology includes assessing tumor response through various assays and measuring specific biomarkers to evaluate the treatment's effectiveness. The trial targets patients with high-grade serous or endometrioid ovarian cancers who meet specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with high-grade epithelial ovarian cancers who have received at least two lines of platinum-based chemotherapy and have measurable disease.

Not a fit: Patients who have not received prior platinum-based chemotherapy or those with non-epithelial ovarian cancers may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with limited responses to existing therapies.

How similar studies have performed: While there is limited data on the combination of these specific agents, previous studies have shown promise in using PARP inhibitors in similar patient populations.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Zhejiang, Hangzhou

• Women's Hospital School Of Medicine Zhejiang University — Zhejiang, Hangzhou, China (Recruiting)

Study contacts

• Study coordinator: yuanming shen, PhD

Conditions Efficacy and Safety; PARPI; Arsenic Trioxide; High Grade Serous Carcinoma; High Grade Endometria Carcinoma; Platinum-resistant Ovarian Cancer; Fuzuloparib