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Study of Apatinib as the Maintenance Therapy in Advanced Lung Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT03376737
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Henan Cancer Hospital

Brief Summary:
The purpose of this study is to confirm the safety and efficacy of Apatinib plus Pemetrexed as the Maintenance Therapy in Advanced Lung Adenocarcinoma.

Condition or disease Intervention/treatment Phase
Lung Adenocarcinoma Drug: Apatinib Phase 2

Detailed Description:
Lung adenocarcinoma is the most common NSCLC,most patient were diagnosed to advanced stage. Maintenance treatment is the continuation of treatment after first-line treatment and before the disease progresses. We consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients. We designed the study to explore the possibility of apatinib for maintenance.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm Phase II Clinical Trial of Apatinib as the Maintenance Therapy in Advanced Lung Adenocarcinoma
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Apatinib + Pemetrexed
Apatinib + Pemetrexed
Drug: Apatinib
Apatinib (250 mg/d) + Pemetrexed (500 mg/m2)
Other Name: Pemetrexed



Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: up to 2 year ]
    From date of randomization until the date of first documented progression or date of death from any cause


Secondary Outcome Measures :
  1. Overall survival(OS) [ Time Frame: up to 2 year ]
    From date of randomization until the date of death from any cause

  2. Objective Response Rate (ORR) [ Time Frame: up to 1 year ]
    From date of randomization until the date of death from any cause



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

Inclusion Criteria:

  1. Histologically or cytologically confirmed of lung adenocarcinoma, EGFR wild-type or known drug-resistant mutation, stage IV or irradiative stage IIIB.
  2. Age ≥ 18 years;
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1;
  4. Patients had previously received at least 4 cycles of first-line, double chemotherapy and had no disease progression at baseline screening compared with baseline imaging prior to first-line chemotherapy;
  5. Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 100×109/L, HB ≥ 90 g/L, TBIL ≤ 1.5×ULN, ALT or AST ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1×ULN, Cr clearance ≥ 45 mL/min;

Exclusion Criteria:

  1. Active brain metastases, meningococcal meningitis, patients with spinal cord compression, or imaging at CT or MRI examination revealed brain or pia mater disease(Patients who have completed treatment and whose symptoms are stable in the first 21 days of randomization may be enrolled in the study but may be diagnosed as having no intracerebral hemorrhage by MRI, CT or venography);
  2. Imaging (CT or MRI) showed that the tumor lesions were ≤ 5 mm from the major vessels or there was a central tumor invading local macrovascular;
  3. Imaging (CT or MRI) showed significant cavitary or necrotic lung tumors, uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal medical therapy), grade II The above myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc interval male ≥ 450 ms, female ≥ 470 ms); NYHA standards, Ⅲ ~ Ⅳ grade cardiac insufficiency, or cardiac ultrasound examination prompted left ventricular ejection Score (LVEF) <50%;
  4. 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 anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like;
  5. 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;
  6. 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.
  7. Patients who manifested arterial/venous thrombus events, e.g. cerebrovascular accident (Including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening(Such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism and so on);
  8. Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g;
  9. Confirmed ALK gene fusion;
  10. Anti-angiogenic drugs were used during first-line chemotherapy。

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): NCT03376737


Contacts
Contact: Guowei Zhang 13949109625 dugu4986@126.com

Locations
China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450008
Contact: Guowei Zhang       dugu4986@126.com   
Sponsors and Collaborators
Henan Cancer Hospital
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Principal Investigator: Zhiyong Ma Henan Cancer Hospital

Responsible Party: Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT03376737     History of Changes
Other Study ID Numbers: AHEAD-HNP012
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors