Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer

NCT04518501 | Recruiting Phase 1 DMC

• 1 other identifier: CESM023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Efficacy and Safety

Keywords

PARPI; Arsenic Trioxide; High Grade Serous Carcinoma; High Grade Endometria Carcinoma; Platinum-resistant Ovarian Cancer; Fuzuloparib

Outcome Measures

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.

  From date of randomization until PD or death from any cause, assessed up to 36 months.

Secondary Outcomes (4)

• OS

  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]

• PFS

  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 months

• the incidence and severity of adverse reactions

  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 months

• quality of life assessment

  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.

Study Arms (1)

study group

EXPERIMENTAL

Fuzuloparib Capsules plus table Arsenic Trioxide po

Drug: Arsenic trioxide Tablet +Fuzuloparib Capsules

Interventions

Arsenic trioxide Tablet +Fuzuloparib Capsules DRUG

Arsenic trioxide Tablet : 0.27\*9 tid po consecutive 21 days with 1 week rest． Fuzuloparib Capsules: 150 mg bid po

study group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xing Xie: lead

Study Sites (1)

Women's Hospital School Of Medicine Zhejiang University

Zhejiang, Hangzhou, 310006, China

RECRUITING

Central Study Contacts

yuanming shen, PhD

CONTACT

13588193832; 13588193832@163.com

xing xie, PhD

CONTACT

13606705128; xiex@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: profressor

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: August 19, 2020
• Study Start: July 1, 2020
• Primary Completion: December 3, 2024
• Study Completion: January 1, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

CN (1)