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Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer

This study is currently recruiting participants.
Verified April 2016 by Tianjin Medical University Cancer Institute and Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02780778
First Posted: May 23, 2016
Last Update Posted: May 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
  Purpose
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.

Condition Intervention Phase
Non-small Cell Lung Cancer Drug: Apatinib Drug: Docetaxel Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: 1 Day ]

Secondary Outcome Measures:
  • objective remission rate [ Time Frame: 1 Day ]
  • disease control rate [ Time Frame: 1 Day ]
  • Quality of life score [ Time Frame: 1 Day ]

Estimated Enrollment: 20
Study Start Date: May 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group
Apatinib:500 mg,po,qd; Docetaxel:60mg/m²,vein input 1hour,every 3w
Drug: Apatinib
Targeted therapy Apatinib:500 mg,po,qd
Other Name: YN968D1
Drug: Docetaxel
chemotherapy Docetaxel:60mg/m²,vein input 1hour,every 3w
Other Name: Taxotere

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780778


Contacts
Contact: Zhanyu Pan, Master 86-13752570372 wangcongalex@126.com

Locations
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Zhanyu Pan, Master    86-13752570372    wangcongalex@126.com   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Principal Investigator: Zhanyu Pan, Master National Clinical Research Center for Cancer of China
  More Information

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT02780778     History of Changes
Other Study ID Numbers: AHEAD-HBL0001
First Submitted: May 3, 2016
First Posted: May 23, 2016
Last Update Posted: May 23, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action