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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03201146
Other study ID # 2009L03464
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received June 25, 2017
Last updated November 16, 2017
Start date June 27, 2017
Est. completion date August 1, 2020

Study information

Verified date November 2017
Source West China Hospital
Contact You Lu, MD
Phone 86-028-85422114
Email radyoulu@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and clinical activity of Apatinib in combination with AP(Pemetrexed/Carboplatin) or AC(Pemetrexed/Carboplatin) as first-line chemotherapy in subjects with advanced EGFR wild type non-squamous non-small cell lung cancer(NSCLC).


Description:

Apatinib, an oral highly potent tyrosine-kinase inhibitor targeting VEGFR-2, has demonstrated improved survival in previously treated patients with advanced non-small-cell lung cancer(NSCLC).

The phase I study is conducted to explore the safety, tolerability, dose-limiting toxicities(DLT), Maximum Tolerable Dose(MTD), and preliminary anti-tumor activity of Apatinib combined with platinum-based doublet chemotherapy(PB-DC) in first-line advanced EGFR wild type non-squamous non-small cell lung cancer. This will use a dose reduction trial design. A cohort of 3~6 subjects will be enrolled at each dose level, If 0 of 3 or ≤ 1 of 6 subjects experience a DLT, the phase I trial will stop and the current dose will be considered the MTD. If 1 of 6 or more subjects experiences a DLT, dose reduce to the next dose will occur.

Following completion of the dose de-escalation trial and determination of MTD, A randomized controlled trial(RCT) including 30 subjects may be enrolled to further evaluate safety, tolerability, and preliminary anti-tumor activity of Apatinib in combination with platinum‐based doublet chemotherapy(PB-DC) in the same target population.


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Study Design


Intervention

Drug:
Apatinib
Doses to be determined following the completion of Phase I of the study.
AP or AC
Pemetrexed(A) 500mg/m2, IV, Day 1; Cisplatin(P) 25mg/m2,IV,Day 1-3 or Carboplatin(C) area under curve(AUC)=5, IV, Day 1; AP or AC will be administered every 21 days starting on Day 1.
Apatinib 250mg
250mg/d,q.d.,p.o.every 21 days.
Apatinib 500mg
500mg/d,q.d.,p.o.every 21 days.
Apatinib 750mg
750mg/d,q.d.,p.o.every 21 days.

Locations

Country Name City State
China West China Hospital, Sichuan University Chengdu Sichuan

Sponsors (2)

Lead Sponsor Collaborator
West China Hospital Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

Li J, Zhao X, Chen L, Guo H, Lv F, Jia K, Yv K, Wang F, Li C, Qian J, Zheng C, Zuo Y. Safety and pharmacokinetics of novel selective vascular endothelial growth factor receptor-2 inhibitor YN968D1 in patients with advanced malignancies. BMC Cancer. 2010 O — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response rate(ORR) To determine ORR of Apatinib in combination with AP or AC in subjects with advanced EGFR wild type non-squamous non-small cell lung cancer. ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 Up to 36 months
Secondary Progression-free survival (PFS) PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause. Up to 36 months
Secondary Disease Control Rate (DCR) Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1. Up to 36 months
Secondary median Overall Survival median Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival. Up to 36 months
Secondary One-year Overall Survival Rate Kaplan Meier methods were used to estimate the 1-year survival probabilities for time to death from any cause. Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. Up to 36 months
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