This open-label, dose finding phase Ib trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together as second-line treatment of patients with extensive stage small cell lung cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.
The degree of malignancy of small cell lung cancer is extremely high. About 60% to 70% of patients are diagnosed as extensive. The median survival time of the disease is only 9 to 10 months, and the 2-year survival rate is less than 10%. Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor. Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibitor.This open-label, dose finding phase Ib trial studies the tolerability and the best dose of fluzoparib in combination with apatinib as second-line treatment of patients with extensive stage small cell lung cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Take Fluzoparib orally(either at 50,100mg bid)until disease progression or appearance of unbearable toxicity
Take apatinib orally (either at 375mg、500mg、750mg qd)until disease progression or appearance of unbearable toxicity
Tianjin Medical University Second Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGPhase Ⅰb: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib with Apatinib
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability and efficacy data collected during the dose escalation portion of the study
Time frame: Up to 28 days after the first dose of Fluzoparib and Apatinib combination therapy
PhaseⅠb: Incidence of Adverse Events [safety and tolerability]
Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v5.0
Time frame: From screening up to 28 days after end of treatment
Phase Ⅱ: Objective Response Rate(ORR) as Assessed by the Investigator according to RECIST v1.1
Objective Response Rate(Complete response + Partial response (CR+PR)), determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points.
Time frame: up to approximately 2 Years
Progression Free Survival(PFS)
Progression Free Survival, defined as first assessment of disease progression or death, whichever is earlier.
Time frame: Up to approximately 2 Years
Overall survival(OS)
Overall survival is the time from intervention to death due to any reason or lost of follow-up
Time frame: Up to approximately 2 Years
Duration of Response(DoR)
Duration of Response, determined using RECIST v1.1 criteria.
Time frame: Up to approximately 2 Years
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Adverse Event Rate(AER)
Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v5.0
Time frame: Up to approximately 2 Years
Biomarker Detection
Evaluation of TP53 gene status through next-generation sequencing technology
Time frame: Up to approximately 2 Years