NCT03416231

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

2.1 years

First QC Date

January 24, 2018

Last Update Submit

January 24, 2018

Conditions

NSCLC

Keywords

apatinibDocetaxel

Outcome Measures

Primary Outcomes (1)

  • objective response rate (ORR)

    Proportion of patients with reduction in tumor burden of a predefined amount

    6 month

Secondary Outcomes (3)

  • progression free survival (PFS)

    12 month

  • disease control rate (DCR)

    6 month

  • 6-month overall survival rate

    6 month

Study Arms (1)

apatinib plus docetaxel

EXPERIMENTAL

apatinib combine with docetaxel， 4\~6 cycles

Drug: ApatinibDrug: Docetaxel

Interventions

ApatinibDRUG

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

Also known as: Aitan
apatinib plus docetaxel
DocetaxelDRUG

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

apatinib plus docetaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Male or female patients, age: ≥ 18 years of age;
  • \. 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;
  • \. Previous drug treatment consisted of a platinum-based chemotherapy regimen (\> 1 chemotherapy regimen) for relapse or failure of treatment.
  • \. 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).
  • \. Sign the inform consent form with good compliance.

You may not qualify if:

  • \. Squamous cell carcinoma (including adenosquamous carcinoma); Small cell lung carcinoma (including small cell carcinoma and non-small cell mixed lung carcinoma)
  • \. Patients who had previously received docetaxel treatment were excluded
  • \. 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).
  • \. Patients with uncontrollable hypertension (systolic blood pressure\> 140 mmHg, diastolic blood pressure\> 90 mmHg, despite optimal drug therapy).
  • \. Patients with with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms).
  • \. According to NYHA standard, grade Ⅲ \~ Ⅳ heart failure, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) \<50%.
  • \. Coagulation dysfunction (INR\> 1.5, PT\> ULN +4s or APTT\> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment.
  • \. Patients treated with anticoagulation agents or Vitamin K antagonist such as Warfarin, heparin, or other similar drugs.
  • \. 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.
  • \. 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.
  • \. 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.
  • \. Known genetic or acquired bleeding or bleeding tendency (such as hemophilia, blood coagulation dysfunction, thrombocytopenia, and hypersplenism, etc.).
  • \. Patients who have unhealed wounds or fractures for a long time.
  • \. Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening.
  • \. Patients with obvious factors affecting absorption of oral drugs, such as difficulties in swallowing, chronic diarrhea and intestinal obstruction, etc.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, 600000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31261514DERIVED

MeSH Terms

Interventions

apatinibDocetaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Daiyuan Ma, M.D

    Affiliated Hospital of North Sichuan Medical College

    PRINCIPAL INVESTIGATOR

  • xin hu, M.D.

    Nanchong Central Hospital

    STUDY DIRECTOR

  • xiangdong fang, M.d.

    Dazhou Central Hospital

    STUDY DIRECTOR

Central Study Contacts

Daiyuan Ma, M.D

CONTACT

868172246171angenpn@gmail.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 24, 2018

First Posted

January 31, 2018

Study Start

November 30, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

January 31, 2018

Record last verified: 2018-01

Locations

CN(1)