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Study on the Adverse Drug Reactions (ADRs) of Apatinib and Their Biomarker Correlations

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.
 
ClinicalTrials.gov Identifier: NCT03475589
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Hao Long, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE March 18, 2018
First Posted Date  ICMJE March 23, 2018
Last Update Posted Date May 12, 2020
Actual Study Start Date  ICMJE February 26, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2018)
metastasis [ Time Frame: eight weeks ]
The patient was diagnosed as recurrence or metastasis according to the computed tomography (CT) scan
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on the Adverse Drug Reactions (ADRs) of Apatinib and Their Biomarker Correlations
Official Title  ICMJE A Clinical Study Investigating Adverse Drug Reactions and Their Biomarker Correlations in Stage IV Cancer Patients Following Individualized Therapy of Apatinib
Brief Summary The tolerability of apatinib, an effective antiangiogenic agent, varies greatly in patients with stage IV cancer during treatment. This study will include patients with advanced (stage IV) gastric cancer, non-small-cell lung cancer (NSCLC), breast cancer or ovarian cancer, who will be administered apatinib treatment starting from 250 mg Qd and closely monitored for ADRs during the period of apatinib treatment. Meanwhile, relevant assay technologies will be used to precisely detect changes of various biomarkers in the patients treated by apatinib, with the aim of identifying biomarkers related to their prognosis and relevant complications so as to screen out the favored population, establish the drug's indication(s) and reduce relevant side effects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Stage IV Cancer
Intervention  ICMJE Drug: apatinib
Patients with advanced (stage IV) gastric cancer, non-small-cell lung cancer (NSCLC), breast cancer or ovarian cancer will be included in this study to receive apatinib treaetment starting from 250 mg Qd and closely monitored for ADRs during apatinib treatment, with dosage adjustment performed as needed to make the treatment tolerable to the patients.
Study Arms  ICMJE single group
Intervention: Drug: apatinib
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2018)
217
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age of 18 and over, male or female;
  2. Patients with histologically confirmed advanced (stage IV) gastric cancer, NSCLC, breast cancer or ovarian cancer, who choose monotherapy of oral vascular targeting drug (apatinib) due to intolerability or inappropriateness of other therapies;
  3. Presence of measurable lesions (≥10mm on spiral CT scan) subject to RECIST 1.1;
  4. Blood pressured controlled at 150/100 mHg following drug administration;
  5. An ECOG PS score of between 0 and 1;
  6. Findings of hematology and laboratory tests at the baseline that meet the following criteria:

    Hemoglobin ≥80g/L; Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelets ≥90×10^9/L; ALT/AST ≤ 2.5×ULN; or ALT/AST ≤ 5×ULN for patients with hepatic metastases; Serum total bilirubin ≤1.5×ULN; Serum urea nitrogen and creatinine ≤ 1.5×ULN; Serum albumin ≥30g/L; Coagulation function (INR≤1.5, APTT≤1.5 ULN);

  7. A life expectancy of at least 3 months;
  8. Subjects who volunteer to participate in this study and have signed the Informed Consent Form (ICF), with good compliance with treatment and follow-up.

Exclusion Criteria:

  1. Confirmed allergy to apatinin and or its excipients;
  2. Hypertension (high blood pressure) that can not be controlled by drugs;
  3. A history of active hemorragge, ulcer, intestinal perforation, intestinal obstruction, or major surgery no older than 30 days;
  4. NYHA III-IV heart function, or severe hepatic or renal insufficiency (Grade 4);
  5. Presence of multiple factors that affect oral medications, such as difficulty swallowing, nausea, vomiting, chronic diarrhea and intestinal obstruction;
  6. Pregnant or lactating women, or women of child-bearing potential who have planned a pregnancy, or male and female patients who do not agree to practice adequate contraception during this study;
  7. Patients who have a history of psychotropics abuse and can not quit, or who have mental disorders;
  8. Participation in other drug clinical trial within the last 4 weeks;
  9. Prior therapy with VEGFR inhibitors such as sorafenib and sunitinib;
  10. Presence of comorbidities that seriously affect the patient's safety or ability to complete the study, in the investigator's judgment;
  11. Patients who can not tolerate apatinib treatment as judged by the investigator depending on the their medical history;
  12. Patients that are considered ineligible for this study by the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hao Long, Prof +86 2087343261 longhao@sysucc.org.cn
Contact: Ruping Xing +86 2087343736 xingrp@sysucc.org.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03475589
Other Study ID Numbers  ICMJE A2018-002
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 Not Provided
Responsible Party Hao Long, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Yat-sen University
Verification Date May 2020

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