A Study of Fluzoparib Combined With Apatinib as Second-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer（FA-ES-SCLC）
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|ClinicalTrials.gov Identifier: NCT04659785|
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : December 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer Extensive Stage||Drug: Fluzoparib Drug: Apatinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Arm,Single-Center, Phase Ib/II Clinical Study of Fluzoparib (SHR-3162) Combined With Apatinib as Second-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer（SCLC）|
|Actual Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Fluzoparib + Apatinib
Fluzoparib and apatinib will be administered continuously and orally in combination, 28 days per cycle, until disease progression or unacceptable toxicity.
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
Other Name: Apatinib mesylate
- Phase Ⅰb: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib with Apatinib [ Time Frame: Up to 28 days after the first dose of Fluzoparib and Apatinib combination therapy ]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
- PhaseⅠb: Incidence of Adverse Events [safety and tolerability] [ Time Frame: From screening up to 28 days after end of treatment ]Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v5.0
- Phase Ⅱ: Objective Response Rate(ORR) as Assessed by the Investigator according to RECIST v1.1 [ Time Frame: up to approximately 2 Years ]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.
- Progression Free Survival（PFS） [ Time Frame: Up to approximately 2 Years ]Progression Free Survival, defined as first assessment of disease progression or death, whichever is earlier.
- Overall survival（OS） [ Time Frame: Up to approximately 2 Years ]Overall survival is the time from intervention to death due to any reason or lost of follow-up
- Duration of Response（DoR） [ Time Frame: Up to approximately 2 Years ]Duration of Response, determined using RECIST v1.1 criteria.
- Adverse Event Rate（AER） [ Time Frame: Up to approximately 2 Years ]Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v5.0
- Biomarker Detection [ Time Frame: Up to approximately 2 Years ]Evaluation of TP53 gene status through next-generation sequencing technology
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04659785
|Contact: Haitao Wang, MDemail@example.com|
|Contact: Li Zang, MDfirstname.lastname@example.org|
|Principal Investigator:||Haitao Wang||Tianjin Medical University Second Hospital|