Rare Diseases

All Conditions

Oculocerebral Syndrome With Hypopigmentation

The first cycle with high-fat meal, the second cycle under fasting.

The first cycle under fasting, the second cycle with high-fat meal.

Fuzuloparib Capsules; 150mg; single dose per cycle.

Fuzuloparib

The objective of the study is to assess the effect of food on the pharmacokinetics, and safety of Fuzuloparib Capsules in healthy subject.

There will be 20 volunteers to receive the treatment, and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic and safety.

A Study of Food Effect on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects

Randomized, Open, Two Cycle, Two Sequence, Cross Reference Designed Study on the Effect of Food on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects

Jiangsu HengRui Medicine Co., Ltd.

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cystadenocarcinoma, Serous

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Arsenic Trioxide

Fuzuloparib Capsules plus table Arsenic Trioxide po

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

Arsenic trioxide Tablet +Fuzuloparib Capsules

yuanming shen, PhD

xing xie, PhD

Xing Xie, PhD

Yuanming Shen, PhD

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.

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.

The investigators' studies have shown that combination therapy with Fuzuloparib and Arsenic trioxide demonstrated a synergistic anti-tumor effect in BRCAness/HR-proficiency ovarian cancer cells:

Firstly, CCK8 and clone formation assays showed that the combination of Fuzuloparib and Arsenic trioxide produced notable tumor cell growth inhibition than either single agent in SKOV3 and CAOV3 cells.

Further, the combination therapy resulted in significantly increased level of γ-H2AX and decreased level of RAD51 by IF.The investigators also found that combination therapy could remarkably induced cell apoptosis, which is associated with induction of cleave-PARP and reduction of p-AKT, when compared with either single drug. (Data not published) Therefore, the investigators hypothesis is that for those platinum-resistance relapsed patients who have received at least twice platinum-based chemotherapy, patients with combinate therapy will get 25% of ORR. And platinum-resistance in combination with Arsenic trioxide therapy is well tolerated.

Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer

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

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.

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.

Evaluate the adverse reactions rate of drugs assessed by number and severity of adverse events in the treatment.

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.

Xing Xie

profressor

Symptoms and General Pathology

Recurrence

Adebrelimab

Yang Sun, Doctor

sun, sunyang

This is a single-arm, exploratory study. People with recurrent platinum-resistant ovarian cancer who have not received any previous systemic antitumor therapy for ovarian cancer were selected to evaluate the efficacy and safety of adebrelimab combined with fuzuloparib.

Adebrelimab Combined With Fuzuloparib in the Treatment of Patients With Recurrent Platinum-resistant Ovarian Cancer.

A Single-arm, Exploratory Study of Adebrelimab Combined With Fuzuloparib in the Treatment of Patients With Recurrent Platinum-resistant Ovarian Cancer

ORR is determined using RECIST v1.1, Defined as the optimal overall response (CR or PR) at the time point assessed from enrollment to the end of neoadjuvant therapy

Defined as the time from the enrollment to death from any cause

It is defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.

DCR is determined using RECIST v1.1, Defined as the rate of disease control (CR or PR or SD) from enrollment to the end of neoadjuvant therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Food Effect on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects	NCT05440006	Solid Tumor	Fuzuloparib	18 Years -	Jiangsu HengRui Medicine Co., Ltd.
Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer	NCT04518501	Efficacy and Sa...	Arsenic trioxid...	18 Years - 70 Years	Women's Hospital School Of Medicine Zhejiang University
Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer	NCT04518501	Efficacy and Sa...	Arsenic trioxid...	18 Years - 70 Years	Women's Hospital School Of Medicine Zhejiang University
Fuzuloparib Arsenic Trioxide Platinum Resistance Relapsed Ovarian Cancer	NCT04518501	Efficacy and Sa...	Arsenic trioxid...	18 Years - 70 Years	Women's Hospital School Of Medicine Zhejiang University
Adebrelimab Combined With Fuzuloparib in the Treatment of Patients With Recurrent Platinum-resistant Ovarian Cancer.	NCT05753826	Ovarian Neoplas... Ovarian Disease...	Adebrelimab Fuzuloparib	18 Years - 70 Years	Fujian Cancer Hospital
A Study of Food Effect on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects	NCT05440006	Solid Tumor	Fuzuloparib	18 Years -	Jiangsu HengRui Medicine Co., Ltd.

Spots Global Cancer Trial Database for fuzuloparib

Every month we try and update this database with for fuzuloparib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fuzuloparib

Every month we try and update this database with for fuzuloparib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fuzuloparib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.