- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Studietype
Registrering (Forventet)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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Guangdong
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GuangZhou, Guangdong, Kina, 510060
- Rekruttering
- Sun Yat-sen University Cancer Center
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Ta kontakt med:
- Hao Long, professor
- Telefonnummer: +86-20-87343314
- E-post: longhao@sysucc.org.cn
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Ta kontakt med:
- Ruping Xing
- Telefonnummer: +86-20-87343736
- E-post: xingrp@sysucc.org.cn
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: enkelt gruppe
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
metastasis
Tidsramme: eight weeks
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The patient was diagnosed as recurrence or metastasis according to the computed tomography (CT) scan
|
eight weeks
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- A2018-002
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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