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

NCT04228601 | Completed Phase 1

• 1 other identifier: SHR3162-Ib/II-112
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (4)

• Phase Ib：Number of Participants With a Dose Limited Toxicity

  Number of Participants With a Dose Limited Toxicity

  Within 28 Days after The First Dose

• Phase Ib：Maximum Tolerated Dose

  Maximum Tolerated Dose

  Up to 8 months

• Phase Ib：Recommended Phase 2 Dose

  Recommended Phase 2 Dose

  Up to 2 years

• Phase II：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 Outcomes (8)

• Adverse events evaluated by NCI CTCAE v5.0

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

• Disease Control Rate

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

• Duration of Response

  Up to 2 years

• Progression-Free-Survival

  Up to 2 years

• Overall-Survival

  Up to 2 years

Study Arms (2)

Fluzoparib+mFOLFIRINOX

EXPERIMENTAL

Fluzoparib+mFOLFIRINOX followed by Fluzoparib maintenance monotherapy

Drug: Fluzoparib; Drug: mFOLFIRINOX

Placebo+mFOLFIRINOX

PLACEBO COMPARATOR

Placebo+mFOLFIRINOX followed by placebo maintenance monotherapy

Drug: Fluzoparib placebo; Drug: mFOLFIRINOX

Interventions

Fluzoparib DRUG

PARP

Also known as: SHR3162

Fluzoparib+mFOLFIRINOX

Fluzoparib placebo DRUG

Placebo

Placebo+mFOLFIRINOX

mFOLFIRINOX DRUG

mFOLFIRINOX

Fluzoparib+mFOLFIRINOX; Placebo+mFOLFIRINOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• 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.

  PMID: 39232761 DERIVED

MeSH Terms

Interventions

fluzoparib

Study Officials

• Xianjun Yu, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 14, 2020
• Study Start: January 21, 2020
• Primary Completion: August 10, 2022
• Study Completion: January 15, 2023
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

CN (2)