NCT04518501 Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer
| NCT ID | NCT04518501 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Xing Xie |
| Condition | Efficacy and Safety |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-07-01 |
| Primary Completion | 2024-12-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2020-07-01 with a primary completion date of 2024-12-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 population that can benefit from PARPi is mainly focusing on BRCAm, then homologous-recombination deficiency patients. Limited data revealed the ORR was only 3-4% in homologous recombination proficiency patients with PARPi therapy. New treatments are urgently needed to improve patient outcomes. To explore the efficacy and safety of Fuzuloparib in combination with Arsenic trioxide therapy in platinum-resistance relapsed Ovarian cancer patients.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04518501 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Efficacy and Safety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04518501 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04518501 currently recruiting?
Yes, NCT04518501 is actively recruiting participants. Contact the research team at 13588193832@163.com for enrollment information.
Where is the NCT04518501 trial being conducted?
This trial is being conducted at Zhejiang, China.
Who is sponsoring the NCT04518501 clinical trial?
NCT04518501 is sponsored by Xing Xie. The trial plans to enroll 50 participants.