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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
1 other identifier
interventional
5
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2020
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2020
CompletedFirst Posted
Study publicly available on registry
March 9, 2020
CompletedStudy Start
First participant enrolled
August 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2022
CompletedMarch 28, 2024
March 1, 2024
1.5 years
March 5, 2020
March 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
PFS by Blinded Independent Central Review (BICR) Using RECIST v1.1
Progression-Free-Survival
up to 3 years
Secondary Outcomes (9)
ORR by BICR Using RECIST v1.1
up to 3 years
DCR by BICR Using RECIST v1.1
up to 3 years
DoR by BICR Using RECIST v1.1
up to 3 years
PFS by Investigators Using RECIST v1.1
up to 3 years
ORR by Investigators Using RECIST v1.1
up to 3 years
- +4 more secondary outcomes
Study Arms (2)
Maintenance Fluzoparib monotherapy
EXPERIMENTALMaintenance placebo monotherapy
PLACEBO COMPARATORInterventions
Fluzoparib capsules po. 150 mg twice daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 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 3rd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Shandong Cancer Hospital and Institute
Jinan, Shandon, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affilited to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital Institute
Chengdu, Sichuan, China
West China Hospital
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yupei Zhao, Ph.D
Peking Union Medical College Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2020
First Posted
March 9, 2020
Study Start
August 19, 2020
Primary Completion
February 18, 2022
Study Completion
February 18, 2022
Last Updated
March 28, 2024
Record last verified: 2024-03