Pancreatic CancerPhase 1NCT04425876
A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Resectable Pancreatic Cancer
A Phase 1 study testing Fluzoparib in people with Pancreatic Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to: a) evaluate the tolerability and safety of the co-administration of Fluzoparib and FOLFIRINOX in patients with resectable pancreatic cancer, and establish a maximum tolerated dose and recommended phase II dose of the combination and b) assess the efficacy of the co-administration of… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Fluzoparib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2020to 1 Sep 2023
- Phase
- Phase 1
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-79 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Expected survival ≥ 6 months.
- Histologically or cytologically confirmed pancreas adenocarcinoma.
- Resectable or borderline resectable pancreatic cancer.
- 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.
- Ability to understand and the willingness to receive a needle biopsy.
- 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 had any chemotherapy or radiotherapy prior to entering the study.
- Patients with metastasis disease.
- Previous treatment with a poly ADP-ribose polymerase (PARP) inhibitor.
- 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.
- 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.
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- 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
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Boyong Shen, M.D.
About this study
Official title: A Phase I Study to Assess the Tolerability, Safety and Efficacy of Fluzoparib in Combination With mFOLFIRINOX as Neoadjuvant and Adjuvant Therapy in Patients With Resectable Pancreatic Cancer
The study is being conducted to: a) evaluate the tolerability and safety of the co-administration of Fluzoparib and FOLFIRINOX in patients with resectable pancreatic cancer, and establish a maximum tolerated dose and recommended phase II dose of the combination and b) assess the efficacy of the co-administration of Fluzoparib and FOLFIRINOX in patients with resectable pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- Fluzoparib
- 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 combined with mFOLFIRINOX followed by maintenance Fluzoparib monotherapy
| Study group | Role | What they receive |
|---|---|---|
| Fluzoparib+mFOLFIRINOX | Experimental | Fluzoparib combined with FOLFIRINOX followed by maintenance Fluzoparib monotherapy Receives: Drug: Fluzoparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a dose limited toxicity
Number of participants with a dose limited toxicity
Measured: 28 Days (first and second cycle)
Maximum tolerated dose
Maximum tolerated dose
Measured: Up to 8 months
RP2D
Recommended Phase 2 Dose
Measured: Up to 8 months
R0 resection rate
R0 resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer
Measured: Up to 2 years
Secondary outcomes (8)
AEs
Incidence of adverse events and associated dose of Fluzoparib
Measured: From the first drug administration to within 30 days for the last drug dose
Resection Rate
Resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer
Measured: Up to 2 years
MPR Rate
Major pathological response rate based on central review
Measured: Up to 2 years
Objective response rate
Objective response rate
Measured: Up to 2 years
Disease-free-survival
Disease-free-survival
Measured: Up to 2 years
Event-Free-Survival
Event-Free-Survival
Measured: Up to 2 years
Overall-Survival
Overall-Survival
Measured: Up to 2 years
Minimum concentration (Cmin)
Minimum observed plasma concentration for Fluzoparib
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start17 Dec 2020
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boyong Shen, M.D., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425876
- Sponsor's protocol ID
- SHR3162-I-116
- Status last verified
- Dec 2020
- First submitted
- 4 Jun 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess the Tolerability, Safety and Efficacy of Fluzoparib in Combination With mFOLFIRINOX as Neoadjuvant and Adjuvant Therapy in Patients With Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04425876
- Acronym / sponsor ID
- SHR3162-I-116
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to: a) evaluate the tolerability and safety of the co-administration of Fluzoparib and FOLFIRINOX in patients with resectable pancreatic cancer, and establish a maximum tolerated dose and recommended phase II dose of the combination and b) assess the efficacy of the co-administration of Fluzoparib and FOLFIRINOX in patients with resectable pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluzoparib+mFOLFIRINOX | Experimental | Drug: FluzoparibFluzoparib combined with FOLFIRINOX followed by maintenance Fluzoparib monotherapy |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18-79 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Expected survival ≥ 6 months.
- Histologically or cytologically confirmed pancreas adenocarcinoma.
- Resectable or borderline resectable pancreatic cancer.
Key exclusion criteria (12 listed)
- Patients who have had any chemotherapy or radiotherapy prior to entering the study.
- Patients with metastasis disease.
- Previous treatment with a poly ADP-ribose polymerase (PARP) inhibitor.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluzoparibAlso: SHR3162Fluzoparib combined with mFOLFIRINOX followed by maintenance Fluzoparib monotherapy | Drug | Fluzoparib+mFOLFIRINOX |
Primary outcome
Number of participants with a dose limited toxicity
Time frame: 28 Days (first and second cycle)
Number of participants with a dose limited toxicity
Maximum tolerated dose
Time frame: Up to 8 months
Maximum tolerated dose
RP2D
Time frame: Up to 8 months
Recommended Phase 2 Dose
R0 resection rate
Time frame: Up to 2 years
R0 resection rate of Fluzoparib in combination with FOLFIRINOX as neoadjuvant therapy in patients with resectable pancreatic cancer
8 secondary outcomes
AEs
Time frame: From the first drug administration to within 30 days for the last drug dose
Resection Rate
Time frame: Up to 2 years
MPR Rate
Time frame: Up to 2 years
Objective response rate
Time frame: Up to 2 years
Disease-free-survival
Time frame: Up to 2 years
Event-Free-Survival
Time frame: Up to 2 years
Overall-Survival
Time frame: Up to 2 years
Minimum concentration (Cmin)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boyong Shen, M.D. principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fluzoparib in people with Pancreatic Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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 10 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunlei Jin, Ph.D (86-021-23511999, jinchunlei@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a dose limited toxicity (time frame: 28 Days (first and second cycle)). 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?
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 31 Dec 2020.