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NCT04518501RecruitingPhase 1/2

Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer

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

Source: ClinicalTrials.gov · Last updated 4 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
50 (estimated)
First submitted
16 Aug 2020
Start date
1 Jul 2020
Primary completion date
3 Dec 2024
Lead sponsor
Xing Xie
NCT number
NCT04518501

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 50
  • From 1 Jul 2020 to the primary completion date, 3 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 illness

  • 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;

Other

  • Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03;
  • Researchers think it is not suitable for enrolling.

Who the study is looking for

  • 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;

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Women's Hospital School Of Medicine Zhejiang University
Coordinator of this site? Confirm its status
ZhejiangChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.