The Efficacy and Safety of Apatinib in Heavily Pretreated Advanced Non-squamous Non-small Cell Lung Cancer

NCT02515435 | Unknown Phase 2 DMC

• 1 other identifier: FK1405
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer treatments. Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2) and also represents mild inhibition to PDGFR, c-Kit and c-src tyrosine kinases. It is an orally bioavailable, small molecule agent which is thought to inhibit VEGF-mediated endothelial cell migration and proliferation thus blocking blood vessel formation in tumor tissues. Previous studies have identified that apatinib was well tolerated at doses below 750mg daily. In phase I/II study, investigators reported an objective response rate of 68%. In a phase III trial conducted in advanced pretreated gastric cancer, the median overall survival was significantly prolonged in the apatinib group compared with placebo group. Thus, in this trial, the investigators aim to investigate the efficacy and safety of apatinib in previously treated advanced non-squamous non-small cell lung cancer.

Conditions

Non-Small Cell Lung Cancer

Keywords

apatinib; NSCLC; safety; efficacy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  To evaluate Objective response rate every 6-8 weeks after the initiation of apatinib.

  tumor assessment every 2 cycles after the initiation of apatinib，up to 24 months

Secondary Outcomes (1)

• Progression free survival

  12 months

Other Outcomes (3)

• Overall survival

  12 months

• side effects

  12 months

• Quality of life

  12 months

Study Arms (1)

apatinib single agent

EXPERIMENTAL

apatinib, single agent, 500mg or 750mg Qd po, continue until disease progression

Drug: apatinib single agent

Interventions

apatinib single agent DRUG

For those heavily treated non-squamous non-small cell lung cancer, treat with apatinib single agent, 500mg or 750mg Qd, p.o based on the status of patient, continue until disease progression, dose reduction was admitted

Also known as: YN968D1

apatinib single agent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obtain of informed consent.
• Aged 18 years and over.
• Histologically or cytologically confirmed non-squamous non-small cell lung cancer.
• World Health Organization (WHO) performance status (PS) of 0 to 2.
• Measurable lesions as defined by RECIST criteria.
• Life expectancy ≥12 weeks.
• Progressed after at least two lines systemic treatment, or were not amendable to receive the current standard therapy
• \. Organ functions normal, as defined below, within two weeks of randomization: Hb≥90g/L Absolute neutrophils count(ANC)≥1.5×109/L Platelets≥80×109/L Serum bilirubin≤2×ULN; Aspartate transaminase(AST) and alanine transaminase (ALT)≤2.5×ULN(≤5×ULN if liver metastases) Creatinine clearance≥45ml/min or Cr≤1.25×ULN 8. Females of child-bearing potential must have negative serum pregnancy test. Sexually active males and females (of childbearing potential) willing to practice contraception during the study.

You may not qualify if:

• Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer.
• Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
• Tumor invade big vessels or close to big vessels (less than 5mm)
• Obvious cavity or necrosis formed in the tumor
• Uncontrolled hypertension
• Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
• Abnormal coagulation (INR\>1.5 or PT\>ULN+4, or APTT\>1.5 ULN), bleeding tendency or receiving coagulation therapy
• Hemoptysis, more than 2.5ml daily
• Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
• Unhealed bone fracture or wound for long time
• Received big surgery, had bone fracture or ulcer in 4 weeks.
• Urine protein≥++, or urine protein in 24 hours≥1.0g
• Pregnant or lactating woman.

Sponsors & Collaborators

• Tongji University: lead

Study Sites (1)

Department of Oncology, Shanghai pulmonary hospital

Shanghai, 200433, China

Location

Related Publications (1)

• Wu F, Zhang S, Xiong A, Gao G, Li W, Cai W, Su C, Chen X, Zhou F, Zhao J, Ren S, Zhou C. A Phase II Clinical Trial of Apatinib in Pretreated Advanced Non-squamous Non-small-cell Lung Cancer. Clin Lung Cancer. 2018 Nov;19(6):e831-e842. doi: 10.1016/j.cllc.2018.06.002. Epub 2018 Jun 27.

  PMID: 30026059 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

apatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• caicun zhou, MD,PhD

  Shanghai Pulmonary Hospital, Tongji University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pro, Dr

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 4, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

CN (1)