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Advanced Pancreatic CancerPhase 1/2NCT04228601

A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Advanced Pancreatic Cancer

A Phase 1/2 study testing Fluzoparib and mFOLFIRINOX in people with Advanced Pancreatic Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is being conducted to: a) evaluate the tolerability and safety of the co-administration of Fluzoparib and mFOLFIRINOX followed by Fluzoparib Maintenance Monotherapy in patients with advanced pancreatic cancer, and establish the maximum tolerated dose and recommended phase II dose of the combination; and b)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Pancreatic Cancer
What is being tested?
Fluzoparib and mFOLFIRINOX
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
2 sitesChina
Study dates
21 Jan 2020to 15 Jan 2023
Phase
Phase 1/2
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 ≥ 6 months.
  • Histologically or cytologically confirmed local advanced/metastatic pancreas adenocarcinoma.
  • 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.
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  • Presence of at least of one measurable lesion in agreement to RECIST criteria.
  • 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.

Who cannot join

  • Patients who have received any chemotherapy for the treatment of pancreatic cancer prior to entering the study.
  • Previous treatment with any poly ADP-ribose polymerase (PARP) inhibitor.
  • Patients who have had radiotherapy or participated in another clinical trial with any investigational agents within 28 days of enrolment (Day 1 visit).
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, irinotecan, 5-Fluorouracil or other agents used in the study.
  • Previous treatment using CYP3A4 inducers within 3 weeks or inhibitors within 2 weeks of enrolment (Day 1 visit).
  • Patients with known or suspected brain metastasis.
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  • 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.
  • Patients with second primary cancer except curatively treated in-situ cancer or slowly progressing malignancy.
  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Phase Ib/II Study to Assess the Tolerability, Safety and Efficacy of Fluzoparib in Combination With mFOLFIRINOX Followed by Fluzoparib Maintenance Monotherapy in Patients With Advanced Pancreatic Cancer

The study is being conducted to: a) evaluate the tolerability and safety of the co-administration of Fluzoparib and mFOLFIRINOX followed by Fluzoparib Maintenance Monotherapy in patients with advanced pancreatic cancer, and establish the maximum tolerated dose and recommended phase II dose of the combination; and b) assess the efficacy of the co-administration of Fluzoparib and mFOLFIRINOX followed by Fluzoparib Maintenance Monotherapy in patients with advanced pancreatic cancer.

Being tested
Fluzoparib, Fluzoparib placebo, mFOLFIRINOX

What participants receive

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

  • FluzoparibDrug

    Also called SHR3162

    PARP

  • Fluzoparib placeboDrug

    Placebo

  • mFOLFIRINOXDrug

    mFOLFIRINOX

Study groups in NCT04228601
Study groupRoleWhat they receive
Fluzoparib+mFOLFIRINOXExperimentalFluzoparib+mFOLFIRINOX followed by Fluzoparib maintenance monotherapy
Receives: Drug: Fluzoparib; Drug: mFOLFIRINOX
Placebo+mFOLFIRINOXPlacebo comparatorPlacebo+mFOLFIRINOX followed by placebo maintenance monotherapy
Receives: Drug: Fluzoparib placebo; Drug: mFOLFIRINOX

What is being measured

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

  1. Phase Ib：Number of Participants With a Dose Limited Toxicity

    Number of Participants With a Dose Limited Toxicity

    Measured: Within 28 Days after The First Dose

  2. Phase Ib：Maximum Tolerated Dose

    Maximum Tolerated Dose

    Measured: Up to 8 months

  3. Phase Ib：Recommended Phase 2 Dose

    Recommended Phase 2 Dose

    Measured: Up to 2 years

  4. Phase II：Objective Response Rate

    Objective response rate according to RECIST 1.1

    Measured: From Week 9 until documented disease progression or study discontinuation (approximately up to 24 months)

Secondary outcomes (8)

  1. Adverse events evaluated by NCI CTCAE v5.0

    Incidence of adverse events and associated dose of Fluzoparib

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

  2. Disease Control Rate

    Disease control rate according to RECIST 1.1

    Measured: From Week 9 until documented disease progression or study discontinuation (approximately up to 24 months)

  3. Duration of Response

    Duration of Response

    Measured: Up to 2 years

  4. Progression-Free-Survival

    Time from randomisation until the date of objective radiological disease progression according to RECIST v1.1 or death

    Measured: Up to 2 years

  5. Overall-Survival

    Time from the date of randomization until death due to any cause

    Measured: Up to 2 years

  6. Area under the curve (AUC)

    Area under the plasma concentration time curve from 0 to 24 hours for Fluroparib

    Measured: 1 year

  7. Maximum concentration (Cmax)

    Maximum observed plasma concentration for Fluzoparib

    Measured: 1 year

  8. Time to maximum concentration (Tmax)

    Time to maximum plasma concentration for Fluzoparib

    Measured: 1 year

Timeline

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

  1. First posted14 Jan 2020
  2. Study start21 Jan 2020
  3. Primary completion10 Aug 2022
  4. Study completion15 Jan 2023

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04228601
Sponsor's protocol ID
SHR3162-Ib/II-112
Status last verified
Aug 2024
First submitted
9 Jan 2020
Last updated
16 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wei M, Liu R, Xu Y, Chen X, Liu C, Bai X, Zhang X, Gao S, Li J, Sheng Z, Lian J, Wang W, Zhang J, Shi S, Xu J, Yu X. Phase 1b study of first-line fuzuloparib combined with modified FOLFIRINOX followed by fuzuloparib maintenance monotherapy in pancreatic adenocarcinoma. BMC Med. 2024 Sep 4;22(1):365. doi: 10.1186/s12916-024-03581-y.

    PubMed 39232761

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Fluzoparib and mFOLFIRINOX in people with Advanced Pancreatic Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 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 9 inclusion and 13 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: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Phase Ib：Number of Participants With a Dose Limited Toxicity (time frame: Within 28 Days after The First Dose). The study lists 4 primary outcomes in all. 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 NCT04228601, which also lists 1 linked publication.

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 16 Aug 2024.

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