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

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

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Pancreatic Cancer
• Intervention / Treatment: Drug: Fluzoparib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital
  • Beijing
    • Beijing, Beijing, China
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China
      • Beijing Cancer hospital
    • Beijing, Beijing, China
      • Chinese PLA General Hospital
  • Chongqing
    • Chongqing, Chongqing, China
      • The First Affiliated Hospital of Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun Yat-sen University Cancer Center
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital
    • Guangzhou, Guangdong, China
      • Sun Yat-sen Memorial Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • The 3rd Affiliated Hospital of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China
      • Hubei Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Cancer Hospital
    • Nanjing, Jiangsu, China
      • Nanjing Drum Tower Hospital
  • Shandon
    • Jinan, Shandon, China
      • Shandong Cancer Hospital and Institute
  • Shanghai
    • Shanghai, Shanghai, China
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai, China
      • Ruijin Hospital, Shanghai JiaoTong University School of Medicine
    • Shanghai, Shanghai, China
      • Changhai Hospital
    • Shanghai, Shanghai, China
      • Huashan Hospital, Fudan University
    • Shanghai, Shanghai, China
      • Xinhua Hospital Affilited to Shanghai Jiao Tong University School of Medicine
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital
    • Chengdu, Sichuan, China
      • Sichuan Cancer Hospital Institute
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University Cancer Institute & Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maintenance Fluzoparib monotherapy	Drug: Fluzoparib; Fluzoparib capsules po. 150 mg twice daily; Other Names: SHR3162
Placebo Comparator: Maintenance placebo monotherapy	Drug: Placebo; Placebo capsules po. twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS by Blinded Independent Central Review (BICR) Using RECIST v1.1	Progression-Free-Survival	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR by BICR Using RECIST v1.1	Objective Response Rate	up to 3 years
DCR by BICR Using RECIST v1.1	Disease Control Rate	up to 3 years
DoR by BICR Using RECIST v1.1	Duration of Response	up to 3 years
PFS by Investigators Using RECIST v1.1	Progression-Free-Survival	up to 3 years
ORR by Investigators Using RECIST v1.1	Objective Response Rate	up to 3 years
DCR by Investigators Using RECIST v1.1	Disease Control Rate	up to 3 years
DoR by Investigators Using RECIST v1.1	Duration of Response	up to 3 years
OS	Overall-Survival	up to 3 years
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Yupei Zhao, Ph.D, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2020
• Primary Completion (Actual): February 18, 2022
• Study Completion (Actual): February 18, 2022

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Fluzoparib
• Other Study ID Numbers: SHR3162-III-304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No