Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzoparib+mFOLFIRINOX | Experimental | Fluzoparib+mFOLFIRINOX followed by Fluzoparib maintenance monotherapy |
|
| Placebo+mFOLFIRINOX | Placebo Comparator | Placebo+mFOLFIRINOX followed by placebo maintenance monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | PARP |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Disease Control Rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xianjun Yu, M.D. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | China | |||
| Zhejiang Provincial People's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39232761 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000722917 | fluzoparib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fluzoparib placebo | Drug | Placebo |
|
| mFOLFIRINOX | Drug | mFOLFIRINOX |
|
Disease control rate according to RECIST 1.1
| From Week 9 until documented disease progression or study discontinuation (approximately up to 24 months) |
| Duration of Response | Duration of Response | Up to 2 years |
| 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 |
| Overall-Survival | Time from the date of randomization until death due to any cause | Up to 2 years |
| Area under the curve (AUC) | Area under the plasma concentration time curve from 0 to 24 hours for Fluroparib | 1 year |
| Maximum concentration (Cmax) | Maximum observed plasma concentration for Fluzoparib | 1 year |
| Time to maximum concentration (Tmax) | Time to maximum plasma concentration for Fluzoparib | 1 year |
| Hangzhou |
| Zhejiang |
| China |