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Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02974933
Recruitment Status : Unknown
Verified February 2017 by Wuling Ou, Hubei Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : November 29, 2016
Last Update Posted : February 17, 2017
Sponsor:
Collaborators:
Jiangsu HengRui Medicine Co., Ltd.
Hubei Clinical Research Collaboration Group
Information provided by (Responsible Party):
Wuling Ou, Hubei Cancer Hospital

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy of apatinib mesylate combined with pemetrexed alone in advanced non-small cell lung cancer patients in the second or second line of treatment of progression-free survival

Condition or disease Intervention/treatment Phase
Nonsmall Cell Lung Cancer Drug: Apatinib combined with pemetrexed Phase 2

Detailed Description:
It is a one-arm study. The progression-free survival will be evaluated.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer ：Single Arm Exploratory Study
Actual Study Start Date : November 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: apatinib
combined with pemetrexed
 Drug: Apatinib combined with pemetrexed
For those pretreated non-squamous non-small cell lung cancer, treat with apatinib 500mg Qd, po.combined with pemetrexed continue until disease progression


Outcome Measures
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Primary Outcome Measures :
  1. progression free survival [ Time Frame: 4 weeks ]
    evaluation per 28 days


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 4 weeks ]
    evaluation per 28 days

  2. disease control rate [ Time Frame: 4 weeks ]
    evaluation per 28 days

  3. objective response rate [ Time Frame: 4 weeks ]
    evaluation per 28 days

  4. Adverse Event [ Time Frame: 4 weeks ]
    evaluation per 28 days


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged from 18 years to 70years.
  2. Histologically or cytologically confirmed non-squamous non-small cell lung cancer(stage IIIB/IV).
  3. Measurable lesions as defined by RECIST criteria.
  4. Locally advanced lung cancer cannot treat with surgery, recurrent or metastatic lung cancer
  5. ECOG performance status (PS) of 0 to 1.
  6. Life expectancy ≥3 months.
  7. Informed consent.

Exclusion Criteria:

  1. Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer.
  2. Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
  3. Tumor invade big vessels or close to big vessels (less than 5mm)
  4. Obvious cavity or necrosis formed in the tumor
  5. Uncontrolled hypertension
  6. Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
  7. Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy
  8. The active HBV or HCV infection
  9. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.
  10. Hemoptysis, more than 2.5ml daily
  11. Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
  12. Unhealed bone fracture or wound for long time
  13. Received big surgery, had bone fracture or ulcer in 4 weeks.
  14. Urine protein≥++, or urine protein in 24 hours≥1.0g
  15. Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment
  16. Have received prior treatment with VEGFR TKI (Bevacizumab is permitted).
  17. Pregnant or lactating woman, or woman unwilling to practice contraception during the study.
Contacts and Locations
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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): NCT02974933


Contacts
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Contact: Ou Wu Ling, MD 609700817@qq.com

Locations
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China, Hubei
Ou wuling Recruiting
Wuhan, Hubei, China, 430079
Contact: Ou Wu ling, 40    13469989766 ext 86    609700817@qq.com   
Sponsors and Collaborators
Wuling Ou
Jiangsu HengRui Medicine Co., Ltd.
Hubei Clinical Research Collaboration Group
More Information
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Responsible Party: Wuling Ou, Deputy Chief Physician, Hubei Cancer Hospital
ClinicalTrials.gov Identifier: NCT02974933    
Other Study ID Numbers: HubeiCH
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wuling Ou, Hubei Cancer Hospital:
apatinib
pemetrexed
NSCLC
Additional relevant MeSH terms:
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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
Pemetrexed
Apatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors