Apatinib in Combination With Docetaxel for Patients With Advanced NSCLC

NCT03411967 | Unknown Phase 2

• 1 other identifier: APTN-L201712
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

In order to explore a new treatment strategy for patients with failed NSCLC platinum-containing double-drug therapy, this study was to investigate the clinical efficacy of apatinib in combination with docetaxel for patients with advanced NSCLC after failure of platinum-based regime

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  6 month

Secondary Outcomes (1)

• PFS

  12 month

Study Arms (1)

apatinib combine with docetaxel

EXPERIMENTAL

Docetaxel, 60 mg / m2, d1, iv + apatinib 500mg, po, qd

Drug: Apatinib; Drug: Docetaxel

Interventions

Apatinib DRUG

apatinib mesylate tablets 500mg, po, qd, continued until the next cycle, taking on an empty stomach (daily taken at the same time), every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment, apatinib has been taken until the disease progresses, intolerable toxicity.

Also known as: Aitan

apatinib combine with docetaxel

Docetaxel DRUG

Docetaxel, 60 mg / m2, d1, iv ,every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment

apatinib combine with docetaxel

Eligibility Criteria

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

You may qualify if:

• ECOG 0-2;
• Expected survival of not less than 12 weeks;
• The first line of platinum-containing chemotherapy, pathologically confirmed IIIB, IV non-small cell lung cancer, with measurable lesions (according to the RECIST 1.1 standard, CT lesion tumor diameter ≥ 10mm, lymph node lesion CT scan diameter ≥ 15mm, measurable lesions have not received radiotherapy, local treatment such as freezing)
• The main organs function properly
• Women of childbearing age must have had reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and are willing to take appropriate measures 8 weeks after and during the last administration of the test drug contraception. In the case of males, consent is to be given to contraception or surgical sterilization 8 weeks after and during the last administration of the test drug;
• Participants volunteered to join the study and signed informed consent form, with good compliance and follow-up.

You may not qualify if:

• Imaging (CT or MRI) showed tumor lesions away from the large blood vessels ≤ 5mm, or the presence of invasive central local blood vessels of the central tumor; or showed the presence of significant lung empty or necrotic tumors;
• Uncontrolled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal drug therapy);
• Has the following cardiovascular disease: Myocardial ischemia or myocardial infarction with grade II or higher, poorly controlled arrhythmia (including QTc intercourse men ≥ 450ms, women ≥ 470ms); NYHA class III-IV cardiomyopathy, Or cardiac ultrasound examination prompted left ventricular ejection fraction (LVEF) \<50%;
• Hemoptysis (INR\> 1.5 or Prothrombin Time (PT)\> ULN + 4 seconds or APTT\> 1.5ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
• In the first 2 months before enrollment, there is obvious slightly blood, or daily hemoptysis volume of 2.5ml or more;
• Within 3 months prior to enrollment, significant clinically significant bleeding symptoms or definite bleeding tendencies such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ at baseline, and above, or vasculitis;
• Incidence of arterial / venous thrombosis within the first 12 months of enrollment such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
• Known hereditary or acquired bleeding and thrombophilia (eg hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc);
• Factors that significantly affect the absorption of oral drugs, such as non-swallowing, chronic diarrhea and intestinal obstruction;
• Urine routine urinary protein ≥ ++, or confirmed 24-hour urinary protein content ≥ 2.0g;
• Previous or concurrent with other unhealed malignancies, except for those having had a cure for cutaneous basal cell carcinoma, carcinoma of the cervix, and superficial bladder cancer;
• Pregnant or lactating women; Reproductive patients who are unwilling or unable to take effective contraception;
• The investigators determine other situations that may affect clinical research and outcome decisions.

Sponsors & Collaborators

• Zigong No.1 Peoples Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

MeSH Terms

Conditions

Lung Neoplasms

Interventions

apatinib; Docetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• 132100694 132100694, M.D.

  Zigong No.1 People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Yan, M.D.

CONTACT

868132100694; 13210069400@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: January 26, 2018
• Study Start: February 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: January 26, 2018

Record last verified: 2018-01