A Study of Maintenance Treatment With Fluzoparib in gBRCA/PALB2 Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy

Metastatic Pancreatic Cancer Clinical Trial

Official title:

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Fluzoparib Monotherapy in Patients With gBRCA/PALB2 Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04300114
• Other study ID #: SHR3162-III-304
• Status: Terminated
• Phase: Phase 3
• Start date: August 19, 2020
• Est. completion date: February 18, 2022

Study information

• Verified date: March 2024
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is being conducted to evaluate the tolerability, safety and efficacy of maintenance Fluzoparib monotherapy in patients with gBRCA/PALB2 mutated metastatic pancreatic cancer whose disease has not progressed on first line platinum based chemotherapy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Aged = 18 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
• Expected survival = 3 months.
• Histologically or cytologically confirmed metastatic pancreas adenocarcinoma.
• Patients who have received a minimum of 16 weeks of continuous platinum treatment for metastatic disease and have no evidence of progression based on investigator's opinion.
• Patients with measurable disease and/or non-measurable or no evidence of disease assessed at baseline by CT or MRI.
• Documented mutation in germline BRCA1/2 or PALB2 that is predicted to be deleterious or suspected deleterious.
• Adequate organ performance based on laboratory blood tests.
• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
• Ability to understand and the willingness to sign a written informed consent document.

Major Exclusion Criteria:

• Previous treatment with a poly ADP-ribose polymerase (PARP) inhibitor.
• Patients who have had radiotherapy within 2 weeks or participated in another clinical trial with any investigational agents within 2 weeks prior to study screening.
• Previous treatment using CYP3A4 inducers within 3 weeks or inhibitors within 2 weeks.
• Significant cardiovascular disease such as New York Heart Associate Class III/IV, cardiac failure, myocardial infarction, unstable arrhythmia, or evidence of ischemia on ECG within 6 months prior to enrolment.
• Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
• Patients with myelodysplastic syndrome/acute myeloid leukaemia.
• Known active hepatitis B or C infection.
• History of immunodeficiency (including HIV infection) or organ transplantation.
• Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Fluzoparib
Fluzoparib capsules po. 150 mg twice daily
• Placebo
Placebo capsules po. twice daily

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Sichuan Cancer Hospital Institute	Chengdu	Sichuan
China	West China Hospital	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Sun Yat-Sen Memorial Hospital	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The 3rd Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	Shandong Cancer Hospital and Institute	Jinan	Shandon
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Changhai Hospital	Shanghai	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Huashan Hospital, Fudan University	Shanghai	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Xinhua Hospital Affilited to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS by Blinded Independent Central Review (BICR) Using RECIST v1.1	Progression-Free-Survival	up to 3 years
Secondary	ORR by BICR Using RECIST v1.1	Objective Response Rate	up to 3 years
Secondary	DCR by BICR Using RECIST v1.1	Disease Control Rate	up to 3 years
Secondary	DoR by BICR Using RECIST v1.1	Duration of Response	up to 3 years
Secondary	PFS by Investigators Using RECIST v1.1	Progression-Free-Survival	up to 3 years
Secondary	ORR by Investigators Using RECIST v1.1	Objective Response Rate	up to 3 years
Secondary	DCR by Investigators Using RECIST v1.1	Disease Control Rate	up to 3 years
Secondary	DoR by Investigators Using RECIST v1.1	Duration of Response	up to 3 years
Secondary	OS	Overall-Survival	up to 3 years
Secondary	Number of participants with treatment-emergent adverse events	The number and proportion of subjects experiencing treatment-emergent adverse events (TEAE)	From the first drug administration to within 30 days for the last drug dose