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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 : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Hao Long, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Stage IV Cancer Drug: apatinib Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 217 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Clinical Study Investigating Adverse Drug Reactions and Their Biomarker Correlations in Stage IV Cancer Patients Following Individualized Therapy of Apatinib
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
single group 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.




Primary Outcome Measures :
  1. metastasis [ Time Frame: eight weeks ]
    The patient was diagnosed as recurrence or metastasis according to the computed tomography (CT) scan



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475589


Contacts
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Contact: Hao Long, Prof +86 2087343261 longhao@sysucc.org.cn
Contact: Ruping Xing +86 2087343736 xingrp@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
GuangZhou, Guangdong, China, 510060
Contact: Hao Long, professor    +86-20-87343314    longhao@sysucc.org.cn   
Contact: Ruping Xing    +86-20-87343736    xingrp@sysucc.org.cn   
Principal Investigator: Hao Long, professor         
Sponsors and Collaborators
Sun Yat-sen University

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Responsible Party: Hao Long, Sun Yat-sen University cancer center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03475589    
Other Study ID Numbers: A2018-002
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hao Long, Sun Yat-sen University:
apatinib; Adverse drug reactions; gastric cancer; non-small cell lung cancer;breast cancer; ovarian cancer
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action