- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03475589
Study on the Adverse Drug Reactions (ADRs) of Apatinib and Their Biomarker Correlations
A Clinical Study Investigating Adverse Drug Reactions and Their Biomarker Correlations in Stage IV Cancer Patients Following Individualized Therapy of Apatinib
Studieoversigt
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Guangdong
-
GuangZhou, Guangdong, Kina, 510060
- Rekruttering
- Sun Yat-sen University Cancer Center
-
Kontakt:
- Hao Long, professor
- Telefonnummer: +86-20-87343314
- E-mail: longhao@sysucc.org.cn
-
Kontakt:
- Ruping Xing
- Telefonnummer: +86-20-87343736
- E-mail: xingrp@sysucc.org.cn
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: enkelt gruppe
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
metastasis
Tidsramme: eight weeks
|
The patient was diagnosed as recurrence or metastasis according to the computed tomography (CT) scan
|
eight weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A2018-002
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Fase IV Kræft
-
Jerome Canady, M.D.Aktiv, ikke rekrutterendeStadie IV lungekræft | Stadie IV blærekræft | Stadie IV Bugspytkirtelkræft | Tilbagevendende malignt fast neoplasma | Stadie IV brystkræft | Stadie IV nyrecellekræft | Stadie IV prostatakræft | Fase IV tyktarmskræft | Stadie IV endetarmskræft | Fase IV Mavekræft | Stadie IV Ikke-småcellet lungekræft | Fase IV Kolorektal... og andre forholdForenede Stater
-
Peter SzmukLuminex Corporation; Outcomes Research ConsortiumAfsluttetIV kanyleringForenede Stater
-
Centre Francois BaclesseRoche Pharma AGAfsluttet
-
Maastricht Radiation OncologyAmsterdam UMC, location VUmcAfsluttet
-
Fondazione Policlinico Universitario Agostino Gemelli...Afsluttet
-
Spanish Lung Cancer GroupAfsluttet
-
Queen's UniversityUkendt
-
HealthPartners InstituteAfsluttetSvær IV AdgangForenede Stater
-
ivWatch, LLCAfsluttet
-
Phoenix Children's HospitalAfsluttetIV Stofbrug | Usikker sexForenede Stater
Kliniske forsøg med apatinib
-
Elevar TherapeuticsAfsluttetAdenoid cystisk karcinomForenede Stater, Korea, Republikken
-
Shanghai Jiao Tong University Affiliated Sixth...UkendtBlødt vævssarkom
-
Tianjin Medical University Cancer Institute and...Ukendt
-
Peking University Cancer Hospital & InstituteRekruttering
-
Tianjin Medical University Second HospitalJiangsu HengRui Medicine Co., Ltd.Ukendt
-
Lei LiAfsluttetKemoterapi | Tilbagevendende cervikal karcinom | Apatinib | Målrettet terapi | Vedvarende avanceret cervikal karcinom | Vaskulær endothelial vækstfaktor 2-hæmmerKina
-
The First Affiliated Hospital of Zhengzhou UniversityRekrutteringEsophageal Cancer af AJCC V8 StageKina
-
Peking UniversityJiangsu HengRui Medicine Co., Ltd.Rekruttering
-
The First Affiliated Hospital of Zhengzhou UniversityRekruttering
-
Peking Union Medical College HospitalAfsluttetKræft i skjoldbruskkirtlenKina