Clinical trial · Interventional
A Study of Maintenance Treatment With Fluzoparib in gBRCA/PALB2 Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Fluzoparib Monotherapy in Patients With gBRCA/PALB2 Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor R \& D Strategy Adjustment
Summary
Brief summary (as posted)
The study is being conducted to evaluate the tolerability, safety and efficacy of maintenance Fluzoparib monotherapy in patients with gBRCA/PALB2 mutated metastatic pancreatic cancer whose disease has not progressed on first line platinum based chemotherapy.
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 |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluzoparib | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Maintenance Fluzoparib monotherapy
- interventionNames
- Drug: Fluzoparib
- type
- PLACEBO_COMPARATOR
- label
- Maintenance placebo monotherapy
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- PFS by Blinded Independent Central Review (BICR) Using RECIST v1.1
- timeFrame
- up to 3 years
- description
- Progression-Free-Survival
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Aged ≥ 18 years. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 * Expected survival ≥ 3 months. * Histologically or cytologically confirmed metastatic pancreas adenocarcinoma. * Patients who have received a minimum of 16 weeks of continuous platinum treatment for metastatic disease and have no evidence of progression based on investigator's opinion. * Patients with measurable disease and/or non-measurable or no evidence of disease assessed at baseline by CT or MRI. * 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. * 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. Major Exclusion Criteria: * Previous treatment with a poly ADP-ribose polymerase (PARP) inhibitor. * Patients who have had radiotherapy within 2 weeks or participated in another clinical trial with any investigational agents within 2 weeks prior to study screening. * 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. * 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