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Maintenance Treatment of Apatinib in Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT03130270
Recruitment Status : Active, not recruiting
First Posted : April 26, 2017
Last Update Posted : May 16, 2018
Sponsor:
Collaborators:
Wuzhou Red Cross Hospital
Guangxi Naxishan Hospital
National Hospital of Guangxi Zhuang Autonomous Region
Information provided by (Responsible Party):
Wei Jiang, Guilin Medical University, China

Tracking Information
First Submitted Date  ICMJE April 21, 2017
First Posted Date  ICMJE April 26, 2017
Last Update Posted Date May 16, 2018
Actual Study Start Date  ICMJE January 1, 2017
Estimated Primary Completion Date April 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
Objective Response Rate (ORR) after Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma [ Time Frame: up to 24 months ]
To evaluate ORR every 6-8 weeks after initiation of apatinib.
Original Primary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
Disease-free survival (DFS) after Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma [ Time Frame: up to 2 years ]
The time from the first day of therapy to locoregional relapse, distant relapse again or tumor-related death.
Change History Complete list of historical versions of study NCT03130270 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
  • Disease-free survival (DFS) [ Time Frame: up to 24 months ]
    The time from the first day of therapy to locoregional relapse, distant relapse again or tumor-related death.
  • Overall survival (OS) [ Time Frame: up to 24 months ]
    The time from the first day of therapy to death or last follow-up.
  • Toxicity evaluation [ Time Frame: up to 24 months ]
    Related toxicities were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
  • Overall survival (OS) [ Time Frame: up to 2 years ]
    The time from the first day of therapy to death or last follow-up.
  • Toxicity evaluation [ Time Frame: up to 2 years ]
    Related toxicities were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maintenance Treatment of Apatinib in Nasopharyngeal Carcinoma
Official Title  ICMJE Phase II Trial of Maintenance Apatinib After Second-Line Treatment for Locally Recurrent or Metastatic Nasopharyngeal Carcinoma
Brief Summary The study is to evaluate the efficacy and safety of Apatinib for later treatment of patients(after second-line treatment for locally recurrent or metastatic nasopharyngeal carcinoma), including overall survival (OS), distant metastasis-free survival (DMFS) and locoregional relapse-free survival (LRRFS); the relationship between EBV DNA copy number and survival after radiotherapy or radiochemotherapy; Quality of life score (QoL); evaluation of drug safety.
Detailed Description In locally advanced nasopharyngeal carcinoma(NPC), although fist-line therapy with radiotherapy and chemotherapy (Cisplatin/Docetaxel/5-Fu) and second-line therapy with chemotherapy has been given, patients still locally recurrence and distant metastasis. There is no standard treatment recommendation for locally recurrent or metastatic NPC who failed to second-line therapy. Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III studies of liver cancer, non small cell lung cancer and other tumors also showed apatinib has less toxicities and better tolerance. However, the clinical application of apatinib in nasopharyngeal carcinoma is still lack of evidence-based medicine. And this trial is designed to investigate the efficacy and safety of apatinib in locally recurrent or metastatic NPC.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE Drug: Apatinib mesylate tablet

Patients with locally recurrent or metastatic nasopharyngeal carcinoma (NPC) after second-line treatment are assigned to receive apatinib mesylate tablet. A treatment cycle was defined as 28 days (4 weeks). The starting dose was 500 mg, orally, qd; tolerance assessment for a cycle, patients with poorly tolerance were treated with low dose (500 mg, qd), and patients with well tolerance were treated with high dose (750 mg, qd). All patients continuous treatment until progression disease or non-tolerated toxicity.

Note: good tolerance was defined that no grade 3/4 hematology or/and non hematologic side effects occurred within 4 weeks after initiation treatment; poor tolerance was defined that grade 3/4 hematology or/and non hematologic side effects appeared within 4 weeks after initiation treatment.

Other Name: No.
Study Arms  ICMJE Experimental: Apatinib group
Apatinib mesylate tablet:the starting dose was 500 mg, orally, qd; tolerance assessment for a cycle, patients with poorly tolerance were treated with low dose (500 mg, qd), and patients with well tolerance were treated with high dose (750 mg, qd).
Intervention: Drug: Apatinib mesylate tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 10, 2018)
29
Original Estimated Enrollment  ICMJE
 (submitted: April 21, 2017)
25
Estimated Study Completion Date  ICMJE December 8, 2019
Estimated Primary Completion Date April 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female patients aged ranging from 18 to 70 years old.
  2. Patients with newly histologically proven nasopharyngeal carcinoma (NPC).
  3. Local recurrent NPC patients after comprehensive treatment, including clinical examination found a clear local area residue: electronic nasopharyngoscope found clear residual or enlarged cervical lymph nodes.
  4. Distant metastatic NPC patients after comprehensive treatment, including liver B ultrasound, chest X-ray, bone scan or other clinicians consider appropriate tests such as CT, MRI or PET/CT found distant metastases.
  5. Comprehensive treatment of local recurrence or distant metastasis after line or second-line therapy found progressive disease.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
  7. Patient who has the expected survival time more than 3 months.
  8. Adequate hematological function: hemoglobin >80 g/L (no transfusion within 14 days), neutrophil count > 1.5×109/L, platelet count 80×109/L.
  9. Adequate liver function (serum total bilirubin ≤ 1.5 mg/dL, serum transminase ≤ 2.5 times higher than upper limit).
  10. Adequate renal function (creatinine clearance ≥ 50 mL/min).
  11. Participants volunteered to participate in this study, signed informed consent, good compliance and cooperated with us to complete the follow-up.

Exclusion Criteria:

  1. Before treatment, MRI showed that the tumor might be an important risk factor (for example, wrapping around the internal carotid artery / vein); or researchers judged that the tumor is a high risk of serious blood vessel bleeding during the treatment.
  2. Patient who has serious hemorrhages, any serious bleeding events classification at 3 degree or more (according to CTCAE4.0) within the last 4 weeks.
  3. Patient who has high blood pressure can not be controlled by a single antihypertensive drug treatment (Systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); any unstable angina pectoris; with a history of angina pectoris were newly diagnosed with angina pectoris within 3 months before screening; any myocardial infarction events occurred within 6 months before screening; arrhythmia (including QTcF: male ≥ 450ms, female ≥ 470 ms) need long time use of antiarrhythmic drugs and heart function insufficiency ≥II according to New York Heart Association class.
  4. Patient who has positive urine protein.
  5. Patient who has abnormal coagulation and bleeding tendency (signed informed consent before 14 days, and must be satisfied: INR is in the normal range without the use of anticoagulants); Application of anticoagulants or vitamin K antagonists such as Hua Falin, heparin or its analogues, with international normalized ratio (INR) is less than 1.5, allows the use of small dose Hua Falin (1 mg orally, once daily) or small dose aspirin (total dose ≤ 100 mg daily).
  6. Medical history of arteriovenous thrombosis event within the past year, such as cerebral vascular accident (including transient ischemic attack) and deep venous thrombosis (venous catheter thrombosis caused by chemotherapy and investigator judged that the patient had recovered, these patients should be except) and pulmonary embolism.
  7. A healed wound for long time or incomplete fracture.
  8. Any factors that affect the oral drug, such as the inability to swallow, diarrhea and intestinal obstruction.
  9. For females: patients should be surgical sterilization or postmenopausal patients, or willing to receive a medical approved contraception during treatment and 6 months after the end of the treatment; serum or urine pregnancy test must be negative, and must be non lactating period within 7 days before study; for males: patients should be treated with surgical sterilization or willing to receive a medical approved contraception during treatment and 6 months after the end of the treatment.
  10. History of psychotropic substance abuse and can not be removed or psychiatric disorders.
  11. Medical history of immunodeficiency, or other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  12. Any serious harm to the subject's safety or evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03130270
Other Study ID Numbers  ICMJE GLMU-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wei Jiang, Guilin Medical University, China
Study Sponsor  ICMJE Guilin Medical University, China
Collaborators  ICMJE
  • Wuzhou Red Cross Hospital
  • Guangxi Naxishan Hospital
  • National Hospital of Guangxi Zhuang Autonomous Region
Investigators  ICMJE
Principal Investigator: Wei Jiang Guilin Medical University
PRS Account Guilin Medical University, China
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP