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

NCT03475589 | Unknown Phase 4

• 1 other identifier: A2018-002
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IV Cancer

Keywords

apatinib； Adverse drug reactions； gastric cancer; non-small cell lung cancer;breast cancer; ovarian cancer

Outcome Measures

Primary Outcomes (1)

• metastasis

  The patient was diagnosed as recurrence or metastasis according to the computed tomography (CT) scan

  eight weeks

Study Arms (1)

single group

OTHER

Drug: apatinib

Interventions

apatinib DRUG

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.

single group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) ≥1.5×10\^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);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Ovarian Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Hao Long, Prof

CONTACT

+86 2087343261; longhao@sysucc.org.cn

Ruping Xing

CONTACT

+86 2087343736; xingrp@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sun Yat-sen University cancer center

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: March 23, 2018
• Study Start: February 26, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

CN (1)