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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
5
Fluzoparib capsules po. 150 mg twice daily
Placebo capsules po. twice daily
Anhui Provincial Hospital
Hefei, Anhui, China
PFS by Blinded Independent Central Review (BICR) Using RECIST v1.1
Progression-Free-Survival
Time frame: up to 3 years
ORR by BICR Using RECIST v1.1
Objective Response Rate
Time frame: up to 3 years
DCR by BICR Using RECIST v1.1
Disease Control Rate
Time frame: up to 3 years
DoR by BICR Using RECIST v1.1
Duration of Response
Time frame: up to 3 years
PFS by Investigators Using RECIST v1.1
Progression-Free-Survival
Time frame: up to 3 years
ORR by Investigators Using RECIST v1.1
Objective Response Rate
Time frame: up to 3 years
DCR by Investigators Using RECIST v1.1
Disease Control Rate
Time frame: up to 3 years
DoR by Investigators Using RECIST v1.1
Duration of Response
Time frame: up to 3 years
OS
Overall-Survival
Time frame: up to 3 years
Number of participants with treatment-emergent adverse events
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The 3rd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
...and 13 more locations
The number and proportion of subjects experiencing treatment-emergent adverse events (TEAE)
Time frame: From the first drug administration to within 30 days for the last drug dose