NCT02780778

Brief Summary

The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）with docetaxel (60 mg/m²) in advanced Non-squamous Non-small cell lung cancer after failure of first line chemotherapy.

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 nonsmall-cell-lung-cancer

Timeline
Completed

Started May 2016

Shorter than P25 for phase_2 nonsmall-cell-lung-cancer

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

May 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 23, 2016

Status Verified

April 1, 2016

Enrollment Period

1.6 years

First QC Date

May 3, 2016

Last Update Submit

May 19, 2016

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • progression-free survival

    1 Day

Secondary Outcomes (3)

  • objective remission rate

    1 Day

  • disease control rate

    1 Day

  • Quality of life score

    1 Day

Study Arms (1)

Treatment group

EXPERIMENTAL

Apatinib：500 mg，po，qd； Docetaxel：60mg/m²，vein input 1hour，every 3w

Drug: ApatinibDrug: Docetaxel

Interventions

ApatinibDRUG

Targeted therapy Apatinib：500 mg，po，qd

Also known as: YN968D1
Treatment group
DocetaxelDRUG

chemotherapy Docetaxel：60mg/m²，vein input 1hour，every 3w

Also known as: Taxotere
Treatment group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 and ≤ 75 years of age
  • Histologically or cytologic confirmed advanced non-squamous and non-small cell lung cancer.
  • EGFR mutation testing negative of sensitive mutations
  • At least one measurable lesion which has not received radiotherapy (larger than 10 mm in diameter by spiral CT scan)
  • Have failed for 1 lines of chemotherapy
  • ECOG performance scale 0 - 1.
  • Life expectancy of more than 3 months.
  • Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
  • More than 4 weeks after operation or radiotherapy
  • More than 4 weeks for cytotoxic agents
  • Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10\^9/L, neutrophils ≥ 1.5×10\^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min,
  • Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

You may not qualify if:

  • Received more than one kind of chemotherapy regimens
  • NSCLC received other VEGFR inhibitors (except beacizumab) or docetaxel chemotherapy
  • Existing therapy related toxicity of prior chemotherapy and/or radiation therapy
  • Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
  • Any factors that influence the usage of oral administration
  • The center of the tumor invaded local large blood vessels
  • Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3).
  • Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.
  • Less than 4 weeks from the last clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

apatinibDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Zhanyu Pan, Master

    National Clinical Research Center for Cancer of China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhanyu Pan, Master

CONTACT

86-13752570372wangcongalex@126.com

Study Design

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

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 23, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 23, 2016

Record last verified: 2016-04

Locations

CN(1)