Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer
ConditionEfficacy and Safety
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorXing Xie
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Sequential
Treatments tested in this trial
Arsenic trioxide Tablet +Fuzuloparib Capsules
DrugArsenic trioxide Tablet : 0.27\*9 tid po consecutive 21 days with 1 week rest． Fuzuloparib Capsules: 150 mg bid po
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: study groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR
ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria among patients with at least one target lesion. Activity was also described in women with nontarget lesions only and in women without any tumor lesion but with elevated CA-125 levels before starting treatment.
Time frame
From date of randomization until PD or death from any cause, assessed up to 36 months.Secondary outcomes
1
OS
overall survival
Time frame
From date of randomization until the date of death from any cause, or date of last follow-up for patients still alive, assessed up to 36 months]2
PFS
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first.
Time frame
From date of randomization until the date of first documented progression or death from any cause, whichever occurred first, or last follow-up for patients alive without progression, assessed up to approximately 36 months3
the incidence and severity of adverse reactions
Evaluate the adverse reactions rate of drugs assessed by number and severity of adverse events in the treatment.
Time frame
A summary of adverse events of each cycle,from date of administration of drugs until 30 days after the last chemotherapy or progression,whichever came first,assessed up to 36 months4
quality of life assessment
according to the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30).The basic content of life quality assessment includes: physical health, mental health, social function, disease status and overall health perception.
Time frame
It will be assessed at baseline and before the administration of drugs at each first day of every two chemotherapy cycles, up to 6 cycles,each cycle is 28days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Xing Xie
Lead sponsor
Women's Hospital School Of Medicine Zhejiang University
Sponsor institution
Source ClinicalTrials.gov