Clinical trial · Interventional
A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Resectable Pancreatic Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluzoparib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fluzoparib+mFOLFIRINOX
- description
- Fluzoparib combined with FOLFIRINOX followed by maintenance Fluzoparib monotherapy
- interventionNames
- Drug: Fluzoparib
Primary outcomes (4)
- measure
- Number of participants with a dose limited toxicity
- timeFrame
- 28 Days (first and second cycle)
- description
- Number of participants with a dose limited toxicity
- measure
- Maximum tolerated dose
- timeFrame
- Up to 8 months
- description
- Maximum tolerated dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.
References
Publications (0)
Data not yet available