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

Primary Purpose

Stage IV Cancer

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

apatinib

About this trial

This is an interventional other trial for Stage IV Cancer focused on measuring apatinib； Adverse drug reactions； gastric cancer; non-small cell lung cancer;breast cancer; ovarian cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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.

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

single group

Arm Description

Outcomes

Primary Outcome Measures

metastasis

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03475589

First Posted

March 18, 2018

Last Updated

May 9, 2020

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03475589

Brief Title

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

Official Title

A Clinical Study Investigating Adverse Drug Reactions and Their Biomarker Correlations in Stage IV Cancer Patients Following Individualized Therapy of Apatinib

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 26, 2018 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage IV Cancer

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

217 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

single group

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

apatinib

Intervention Description

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.

Primary Outcome Measure Information:

Title

metastasis

Description

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

Time Frame

eight weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hao Long, Prof

Phone

+86 2087343261

longhao@sysucc.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Ruping Xing

Phone

+86 2087343736

xingrp@sysucc.org.cn

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

GuangZhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hao Long, professor

Phone

+86-20-87343314

longhao@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Ruping Xing

Phone

+86-20-87343736

xingrp@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Hao Long, professor

12. IPD Sharing Statement

Learn more about this trial

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

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