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

Advanced Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04228601
• Other study ID #: SHR3162-Ib/II-112
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 21, 2020
• Est. completion date: February 1, 2023

Study information

• Verified date: May 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Chunlei Jin, Ph.D
• Phone: 86-021-23511999
• Email: jinchunlei[@]hrglobe.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) assess the efficacy of the co-administration of Fluzoparib and mFOLFIRINOX followed by Fluzoparib Maintenance Monotherapy in patients with advanced pancreatic cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: February 1, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Advanced Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Fluzoparib
PARP
• Fluzoparib placebo
Placebo
• mFOLFIRINOX
mFOLFIRINOX

Locations

Country	Name	City	State
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Dose Limited Toxicity	Number of Participants With a Dose Limited Toxicity	Within 28 Days after The First Dose
Primary	Maximum Tolerated Dose	Maximum Tolerated Dose	Time Frame: Up to 8 months
Primary	Objective Response Rate	Objective response rate according to RECIST 1.1	From Week 9 until documented disease progression or study discontinuation (approximately up to 24 months)
Secondary	Adverse events evaluated by NCI CTCAE v5.0	Incidence of adverse events and associated dose of Fluzoparib	From the first drug administration to within 30 days for the last drug dose
Secondary	Disease Control Rate	Disease control rate according to RECIST 1.1	From Week 9 until documented disease progression or study discontinuation (approximately up to 24 months)
Secondary	Duration of Response	Duration of Response	Up to 2 years
Secondary	Progression-Free-Survival	Time from randomisation until the date of objective radiological disease progression according to RECIST v1.1 or death	Up to 2 years
Secondary	Overall-Survival	Time from the date of randomization until death due to any cause	Up to 2 years
Secondary	Area under the curve (AUC)	Area under the plasma concentration time curve from 0 to 24 hours for Fluroparib	1 year
Secondary	Maximum concentration (Cmax)	Maximum observed plasma concentration for Fluzoparib	1 year
Secondary	Time to maximum concentration (Tmax)	Time to maximum plasma concentration for Fluzoparib	1 year