Apatinib Plus Docetaxel in Advanced Non-squamous Non-small Cell Lung Cancer(NSCLC)

NCT ID: NCT03416231

Last Updated: 2018-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2020-01-01

Brief Summary

The purpose of this study was to evaluate the effectiveness and safety of apatinib combined with docetaxel in NSCLC.

Conditions

NSCLC

Keywords

apatinib; Docetaxel

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

apatinib plus docetaxel

apatinib combine with docetaxel， 4\~6 cycles

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

apatinib, at a dose of 250 mg daily,Treatment was continued until disease progression.

Docetaxel

Intervention Type: DRUG

Docetaxel, at a dose of 75mg/m2 on days 1 and 22, repeat every 4 weeks for 4\~6 cycles.

Interventions

Apatinib

apatinib, at a dose of 250 mg daily,Treatment was continued until disease progression.

Intervention Type: DRUG

Docetaxel

Docetaxel, at a dose of 75mg/m2 on days 1 and 22, repeat every 4 weeks for 4\~6 cycles.

Intervention Type: DRUG

Other Intervention Names

Aitan

Eligibility Criteria

Inclusion Criteria

• 1. Male or female patients, age: ≥ 18 years of age;
• 2. Pathologically diagnosed late (stage IIIB, stage IV, see Annex 1) non-squamous non-small cell lung cancer with measurable lesions (CT scan of tumor lesion longer than 10 mm in diameter, shorter than 15 CT scan of lymph nodes mm, the scanning layer thickness is not more than 5 mm;
• 3. Previous drug treatment consisted of a platinum-based chemotherapy regimen (> 1 chemotherapy regimen) for relapse or failure of treatment.
• 4. The main organs function properly, that is, within 14 days prior to the relevant indicators meet the following requirements:(1) a. Hemoglobin (HB) ≥90 g / L; (no blood transfusion within 14 days):b. neutrophil count (ANC) ≥ 1.5 × 109 / L; c. Platelet count (PLT) ≥80 × 109 / L;(2) biochemical tests to meet the following criteria:a. Total bilirubin (TBIL) <1.5?ULN (upper limit of normal);b. Blood alanine aminotransferase (ALT) and aspartate aminotransferase (AST).

5. Sign the inform consent form with good compliance.

Exclusion Criteria

• 1. Squamous cell carcinoma (including adenosquamous carcinoma); Small cell lung carcinoma (including small cell carcinoma and non-small cell mixed lung carcinoma)
• 2. Patients who had previously received docetaxel treatment were excluded
• 3. Patients with active brain metastasis, carcinomatous meningitis, or spinal compression, or disease of brain or pia mater according to the screening test, imaging, CT or MRI tests (patients who have completed the treatment and in a stable condition 21 days before screening could be included, but brain MRI, CT or venography is required to confirm that there are no brain hemorrhage symptoms).
• 4. Patients with uncontrollable hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, despite optimal drug therapy).
• 5. Patients with with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms).
• 6. According to NYHA standard, grade Ⅲ ~ Ⅳ heart failure, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) <50%.
• 7. Coagulation dysfunction (INR> 1.5, PT> ULN +4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment.
• 8. Patients treated with anticoagulation agents or Vitamin K antagonist such as Warfarin, heparin, or other similar drugs.
• 9. Patients who had obvious hemoptysis within 2 months before screening, or experienced daily hemoptysis with a volume more than half a tea spoon (2.5ml) or above.
• 10. Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc.
• 11. Patients who manifested arterial/venous thrombus events, e.g. cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening.
• 12. Known genetic or acquired bleeding or bleeding tendency (such as hemophilia, blood coagulation dysfunction, thrombocytopenia, and hypersplenism, etc.).
• 13. Patients who have unhealed wounds or fractures for a long time.
• 14. Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening.
• 15. Patients with obvious factors affecting absorption of oral drugs, such as difficulties in swallowing, chronic diarrhea and intestinal obstruction, etc.
• 16. Occurrence of abdominal fistula, gastrointestinal perforation, or intraperitoneal abscess within 6 months before screening.
• 17. Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g.
• 18. Patients with active hepatitis B virus or hepatitis c virus infection.
• 19. Active infection requiring antimicrobial treatment, such as antibacterial, antifungal, or antiviral therapy.
• 20. Patients with clinical symptoms, or dropsy of serous cavity requiring surgical treatment (including hydrothorax, ascites, and hydropericardium).
• 21. Patients who have a history of psychotropic drug abuse and are unable to break the habit, or who have a psychogeny.
• 22. Patients who have taken part in other drug clinical tests within 4 weeks before screening.
• 23. Prior VEGFR inhibitor treatment.
• 24. Patients who formerly suffered from or currently are complicated with other uncured malignant tumors, except basal cell carcinoma, carcinoma in situ of cervix and superficial bladder cancer that have been cured.
• 25. Patients who received the treatment with potent CYP3A4 inhibitors within 7 days before screening, or potent CYP3A4 inducers within 12 days before being included.
• 26. Pregnant or lactating women, fertile patients who are unwilling or unable to take effective contraceptive measures.
• 27. Conditions determined by investigators to possibly affect the clinical study or determination of the study results.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Affiliated Hospital of North Sichuan Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daiyuan Ma, M.D

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of North Sichuan Medical College

xin hu, M.D.

Role: STUDY_DIRECTOR

Nanchong Central Hospital

xiangdong fang, M.d.

Role: STUDY_DIRECTOR

Dazhou Central Hospital

Locations

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Daiyuan Ma, M.D

Role: CONTACT

Phone: 868172246171

Email: angenpn@gmail.com

Facility Contacts

Daiyuan Ma, M.D

Role: primary

References

Jiang Q, Zhang NL, Ma DY, Tan BX, Hu X, Fang XD. Efficacy and safety of apatinib plus docetaxel as the second or above line treatment in advanced nonsquamous NSCLC: A multi center prospective study. Medicine (Baltimore). 2019 Jun;98(26):e16065. doi: 10.1097/MD.0000000000016065.

Reference Type: DERIVED

PMID: 31261514 (View on PubMed)

Other Identifiers

APTN-ANSCLC-2017-001

Identifier Type: -

Identifier Source: org_study_id