Apatinib in Combination With Docetaxel for Patients With Advanced NSCLC

• ClinicalTrials.gov Identifier: NCT03411967
• Recruitment Status: Unknown
• First Posted: January 26, 2018
• Last Update Posted: January 26, 2018
• Sponsor: Zigong No.1 Peoples Hospital
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.
• Information provided by (Responsible Party): Zigong No.1 Peoples Hospital

Study Description

Brief Summary:

In order to explore a new treatment strategy for patients with failed NSCLC platinum-containing double-drug therapy, this study was to investigate the clinical efficacy of apatinib in combination with docetaxel for patients with advanced NSCLC after failure of platinum-based regime

Condition or disease	Intervention/treatment	Phase
Lung Cancer	Drug: Apatinib; Drug: Docetaxel	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Study of Apatinib in Combination With Docetaxel for Patients With Advanced NSCLC After Failure of Platinum-based Double-drug Therapy
• Estimated Study Start Date: February 1, 2018
• Estimated Primary Completion Date: December 1, 2020
• Estimated Study Completion Date: December 1, 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: apatinib combine with docetaxel; Docetaxel, 60 mg / m2, d1, iv + apatinib 500mg, po, qd

Drug: Apatinib; apatinib mesylate tablets 500mg, po, qd, continued until the next cycle, taking on an empty stomach (daily taken at the same time), every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment, apatinib has been taken until the disease progresses, intolerable toxicity.; Other Name: Aitan; Drug: Docetaxel; Docetaxel, 60 mg / m2, d1, iv ,every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment

Outcome Measures

Primary Outcome Measures :

1. ORR [ Time Frame: 6 month ]
   Objective Response Rate

Secondary Outcome Measures :

1. PFS [ Time Frame: 12 month ]
   Progress-Free Survival

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. ECOG 0-2;
2. Expected survival of not less than 12 weeks;
3. The first line of platinum-containing chemotherapy, pathologically confirmed IIIB, IV non-small cell lung cancer, with measurable lesions (according to the RECIST 1.1 standard, CT lesion tumor diameter ≥ 10mm, lymph node lesion CT scan diameter ≥ 15mm, measurable lesions have not received radiotherapy, local treatment such as freezing)
4. The main organs function properly
5. Women of childbearing age must have had reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and are willing to take appropriate measures 8 weeks after and during the last administration of the test drug contraception. In the case of males, consent is to be given to contraception or surgical sterilization 8 weeks after and during the last administration of the test drug;
6. Participants volunteered to join the study and signed informed consent form, with good compliance and follow-up.

Exclusion Criteria:

1. Imaging (CT or MRI) showed tumor lesions away from the large blood vessels ≤ 5mm, or the presence of invasive central local blood vessels of the central tumor; or showed the presence of significant lung empty or necrotic tumors;
2. Uncontrolled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal drug therapy);
3. Has the following cardiovascular disease: Myocardial ischemia or myocardial infarction with grade II or higher, poorly controlled arrhythmia (including QTc intercourse men ≥ 450ms, women ≥ 470ms); NYHA class III-IV cardiomyopathy, Or cardiac ultrasound examination prompted left ventricular ejection fraction (LVEF) <50%;
4. Hemoptysis (INR> 1.5 or Prothrombin Time (PT)> ULN + 4 seconds or APTT> 1.5ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
5. In the first 2 months before enrollment, there is obvious slightly blood, or daily hemoptysis volume of 2.5ml or more;
6. Within 3 months prior to enrollment, significant clinically significant bleeding symptoms or definite bleeding tendencies such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ at baseline, and above, or vasculitis;
7. Incidence of arterial / venous thrombosis within the first 12 months of enrollment such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
8. Known hereditary or acquired bleeding and thrombophilia (eg hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc);
9. Factors that significantly affect the absorption of oral drugs, such as non-swallowing, chronic diarrhea and intestinal obstruction;
10. Urine routine urinary protein ≥ ++, or confirmed 24-hour urinary protein content ≥ 2.0g;
11. Previous or concurrent with other unhealed malignancies, except for those having had a cure for cutaneous basal cell carcinoma, carcinoma of the cervix, and superficial bladder cancer;
12. Pregnant or lactating women; Reproductive patients who are unwilling or unable to take effective contraception;
13. The investigators determine other situations that may affect clinical research and outcome decisions.

Contacts and Locations

Contacts

Contact: Jun Yan, M.D.; 868132100694; 13210069400@163.com

Sponsors and Collaborators

Zigong No.1 Peoples Hospital

Jiangsu HengRui Medicine Co., Ltd.

Investigators

• Principal Investigator: 132100694 132100694, M.D.; Zigong No.1 People's Hospital

More Information

• Responsible Party: Zigong No.1 Peoples Hospital
• ClinicalTrials.gov Identifier: NCT03411967
• Other Study ID Numbers: APTN-L201712
• First Posted: January 26, 2018
• Last Update Posted: January 26, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:

Docetaxel; Apatinib; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Protein Kinase Inhibitors; Enzyme Inhibitors