Trials / Completed
CompletedNCT04228601
A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Advanced Pancreatic Cancer
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fluzoparib | PARP |
| DRUG | Fluzoparib placebo | Placebo |
| DRUG | mFOLFIRINOX | mFOLFIRINOX |
Timeline
- Start date
- 2020-01-21
- Primary completion
- 2022-08-10
- Completion
- 2023-01-15
- First posted
- 2020-01-14
- Last updated
- 2024-08-16
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04228601. Inclusion in this directory is not an endorsement.