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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04300114
Collaborator
(none)
136
24
2
27.4
5.7
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
136 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 19, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. PFS by Blinded Independent Central Review (BICR) Using RECIST v1.1 [up to 3 years]

      Progression-Free-Survival

    Secondary Outcome Measures

    1. ORR by BICR Using RECIST v1.1 [up to 3 years]

      Objective Response Rate

    2. DCR by BICR Using RECIST v1.1 [up to 3 years]

      Disease Control Rate

    3. DoR by BICR Using RECIST v1.1 [up to 3 years]

      Duration of Response

    4. PFS by Investigators Using RECIST v1.1 [up to 3 years]

      Progression-Free-Survival

    5. ORR by Investigators Using RECIST v1.1 [up to 3 years]

      Objective Response Rate

    6. DCR by Investigators Using RECIST v1.1 [up to 3 years]

      Disease Control Rate

    7. DoR by Investigators Using RECIST v1.1 [up to 3 years]

      Duration of Response

    8. OS [up to 3 years]

      Overall-Survival

    9. Number of participants with treatment-emergent adverse events [From the first drug administration to within 30 days for the last drug dose]

      The number and proportion of subjects experiencing treatment-emergent adverse events (TEAE)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anhui Provincial Hospital Hefei Anhui China 230001
    2 Beijing Cancer Hospital Beijing Beijing China
    3 Beijing Cancer Hospital Beijing Beijing China
    4 Chinese PLA General Hospital Beijing Beijing China
    5 Peking Union Medical College Hospital Beijing Beijing China
    6 The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing China
    7 Guangdong Provincial People's Hospital Guangzhou Guangdong China
    8 Sun Yat-Sen Memorial Hospital Guangzhou Guangdong China
    9 Sun Yat-sen University Cancer Center Guangzhou Guangdong China
    10 The 3rd Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China
    11 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China
    12 Hubei Cancer Hospital Wuhan Hubei China
    13 Jiangsu Cancer Hospital Nanjing Jiangsu China 210009
    14 Nanjing Drum Tower Hospital Nanjing Jiangsu China
    15 Shandong Cancer Hospital and Institute Jinan Shandon China
    16 Changhai Hospital Shanghai Shanghai China
    17 Fudan University Shanghai Cancer Center Shanghai Shanghai China
    18 Huashan Hospital, Fudan University Shanghai Shanghai China
    19 Ruijin Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai China
    20 Xinhua Hospital Affilited to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China
    21 Sichuan Cancer Hospital Institute Chengdu Sichuan China
    22 West China Hospital Chengdu Sichuan China
    23 Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin China
    24 The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang China

    Sponsors and Collaborators

    • Jiangsu HengRui Medicine Co., Ltd.

    Investigators

    • Principal Investigator: Yupei Zhao, Ph.D, Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jiangsu HengRui Medicine Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04300114
    Other Study ID Numbers:
    • SHR3162-III-304
    First Posted:
    Mar 9, 2020
    Last Update Posted:
    Jan 11, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 11, 2021