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Metastatic Pancreatic CancerPhase 3NCT04300114

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 3 study testing Fluzoparib in people with Metastatic Pancreatic Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 23 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
Fluzoparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5 participants
Where
23 sitesChina
Study dates
19 Aug 2020to 18 Feb 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 20Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

China23 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Sichuan Cancer Hospital Institute

    Chengdu, Sichuan

  • West China Hospital

    Chengdu, Sichuan

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • Sun Yat-Sen Memorial Hospital

    Guangzhou, Guangdong

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • The 3rd Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • Shandong Cancer Hospital and Institute

    Jinan, Shandon

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

  • Changhai Hospital

    Shanghai, Shanghai Municipality

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

  • Xinhua Hospital Affilited to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

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

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.

Being tested
Fluzoparib, Placebo
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluzoparibDrug

    Also called SHR3162

    Fluzoparib capsules po. 150 mg twice daily

  • PlaceboDrug

    Placebo capsules po. twice daily

Study groups in NCT04300114
Study groupRoleWhat they receive
Maintenance Fluzoparib monotherapyExperimentalNot described
Receives: Drug: Fluzoparib
Maintenance placebo monotherapyPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS by Blinded Independent Central Review (BICR) Using RECIST v1.1

    Progression-Free-Survival

    Measured: up to 3 years

Secondary outcomes (9)

  1. ORR by BICR Using RECIST v1.1

    Objective Response Rate

    Measured: up to 3 years

  2. DCR by BICR Using RECIST v1.1

    Disease Control Rate

    Measured: up to 3 years

  3. DoR by BICR Using RECIST v1.1

    Duration of Response

    Measured: up to 3 years

  4. PFS by Investigators Using RECIST v1.1

    Progression-Free-Survival

    Measured: up to 3 years

  5. ORR by Investigators Using RECIST v1.1

    Objective Response Rate

    Measured: up to 3 years

  6. DCR by Investigators Using RECIST v1.1

    Disease Control Rate

    Measured: up to 3 years

  7. DoR by Investigators Using RECIST v1.1

    Duration of Response

    Measured: up to 3 years

  8. OS

    Overall-Survival

    Measured: up to 3 years

  9. Number of participants with treatment-emergent adverse events

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

    Measured: From the first drug administration to within 30 days for the last drug dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2020
  2. Study start19 Aug 2020
  3. Primary completion18 Feb 2022
  4. Study completion18 Feb 2022

Why it stopped: Sponsor R \& D Strategy Adjustment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04300114
Sponsor's protocol ID
SHR3162-III-304
Status last verified
Mar 2024
First submitted
5 Mar 2020
Last updated
28 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluzoparib in people with Metastatic Pancreatic Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 23 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor R \& D Strategy Adjustment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS by Blinded Independent Central Review (BICR) Using RECIST v1.1 (time frame: up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04300114.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.

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