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

  • STATUS
    Recruiting
  • End date
    Dec 24, 2021
  • participants needed
    217
  • sponsor
    Sun Yat-sen University
Updated on 24 January 2021

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.

Details
Condition Stage IV Cancer
Treatment apatinib
Clinical Study IdentifierNCT03475589
SponsorSun Yat-sen University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Stage IV Cancer?
Do you have any of these conditions: Do you have Stage IV Cancer??
Age of 18 and over, male or female
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
Presence of measurable lesions (10mm on spiral CT scan) subject to RECIST 1.1
Blood pressured controlled at 150/100 mHg following drug administration
An ECOG PS score of between 0 and 1
Findings of hematology and laboratory tests at the baseline that meet the following
criteria
Hemoglobin 80g/L; Absolute neutrophil count (ANC) 1.510^9/L; Platelets
^9/L; ALT/AST 2.5ULN; or ALT/AST 5ULN for patients with hepatic
metastases; Serum total bilirubin 1.5ULN; Serum urea nitrogen and creatinine
5ULN; Serum albumin 30g/L; Coagulation function (INR1.5, APTT1.5 ULN)
\. A life expectancy of at least 3 months
\. 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

Confirmed allergy to apatinin and or its excipients
Hypertension (high blood pressure) that can not be controlled by drugs
A history of active hemorragge, ulcer, intestinal perforation, intestinal obstruction, or major surgery no older than 30 days
NYHA III-IV heart function, or severe hepatic or renal insufficiency (Grade 4)
Presence of multiple factors that affect oral medications, such as difficulty swallowing, nausea, vomiting, chronic diarrhea and intestinal obstruction
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
Patients who have a history of psychotropics abuse and can not quit, or who have mental disorders
Participation in other drug clinical trial within the last 4 weeks
Prior therapy with VEGFR inhibitors such as sorafenib and sunitinib
Presence of comorbidities that seriously affect the patient's safety or ability to complete the study, in the investigator's judgment
Patients who can not tolerate apatinib treatment as judged by the investigator depending on the their medical history
Patients that are considered ineligible for this study by the investigator
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