- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05131841
Cipterbin Combined With Vinorelbine in the Treatment of HER2-positive MBC
11. november 2021 oppdatert av: wangxiaojia, Zhejiang Cancer Hospital
A Multi-center, Randomized, Open-label Study on Pharmacokinetics, Safety, Efficacy, and Immunogenicity of Cipterbin Combined With Vinorelbine Injection Every Week or Every Three Weeks in the Treatment of Patients With HER2-positive Metastatic Breast Cancer
To compare pharmacokinetics Index of Cipterbin combined with Vinorelbine Injection every week or every three weeks in the treatment of patients with HER2-positive metastatic breast cancer
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
A multi-center, randomized, open-label study on pharmacokinetics, safety, efficacy, and immunogenicity of Cipterbin combined with Vinorelbine Injection every week or every three weeks in the treatment of patients with HER2-positive metastatic breast cancer.
The main purpose was to compare pharmacokinetics Index between two groups, secondly to observe safety, efficacy, and immunogenicity
Studietype
Intervensjonell
Registrering (Forventet)
60
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310000
- Rekruttering
- Zhejiang Cancer Hospital
-
Ta kontakt med:
- Xiaojia Wang
- Telefonnummer: +86 13906500190
- E-post: wxiaojia0803@163.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Age ≥18 and ≤70 years old, female.
- BMI index in the range of 19.0~28.0
- ECOG≤1, and the expected os ≥3 months
- Unresectable metastatic breast cancer diagnosed by histology or pathology that has received one or more chemotherapy regimens.
- HER2 overexpression is +++ by immunohistochemistry (IHC) or + by fluorescence hybridization FISH.
- At least one measurable lesion.
- Sufficient organ function
- Voluntarily signed an informed consent form.
- Subjects with good compliance
Exclusion Criteria:
- Rapid disease progression or threaten important organs and require urgent replacement therapy.
- Undergone surgery within 28 days before treatment (except for biopsy)
- Received radiotherapy within 21 days before the first study drug treatment or the side effects of radiotherapy have not recovered to 0 or 1
- Suffer from other serious uncontrolled diseases (such as epilepsy, liver failure, kidney failure, etc.)
- Suffered from other malignant tumors within 5 years before receiving the first study drug treatment or at the same time.
- Severely infected
- Clear history of mental illness, or have a history of alcoholism or drug abuse.
- Central nervous system metastasis or meningeal metastasis with clinical symptoms
- Cardiac function left ventricular ejection fraction < 50%
- Obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, severe heart valve Membrane disease patients
- Poorly controlled hypertension
- Patients with coagulopathy: INR or APTT ≥1.5×ULN
- Allergic to the test drug or its excipients in the study treatment, or have a severe allergic reaction to other monoclonal antibody drugs in the past
- Pregnant or breastfeeding, or cannot take reliable contraceptive measures during the trial and within 6 months after the end of the medication Giver
- Have received a certain test drug in other interventional clinical trials, the interval is less than 28 days or less than 5 half lives of the drug (whichever is longer)
- Have used a monoclonal antibody within 6 months before receiving the first study drug treatment
- Have received other drugs that may affect the pharmacokinetic results of the study drug, the interval is less than 28 days or less than 5 half lives of the drug (whichever is longer)
- Have received organ transplants (including autologous/allologous stem cell transplants) in the past
- Other conditions judged by the investigator to be inappropriate for participating in this trial
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: One-week group
Cipterbin combined with Vinorelbine Injection every week in the treatment of patients with HER2-positive metastatic breast cancer
|
|
Eksperimentell: Three-week group
Cipterbin combined with Vinorelbine Injection every three weeks in the treatment of patients with HER2-positive metastatic breast cancer
|
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Cmax
Tidsramme: From enrollment to 21 days after the last dose administrate
|
Cmax after the last administration
|
From enrollment to 21 days after the last dose administrate
|
Cmin
Tidsramme: From enrollment to 21 days after the last dose administrate
|
Cmin after the last administration
|
From enrollment to 21 days after the last dose administrate
|
AUC0-t
Tidsramme: From enrollment to 21 days after the last dose administrate
|
AUC0-t after the last administration
|
From enrollment to 21 days after the last dose administrate
|
AUCtau
Tidsramme: From enrollment to 21 days after the last dose administrate
|
AUCtau after the last administration
|
From enrollment to 21 days after the last dose administrate
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Multiple sets of Cmax
Tidsramme: From enrollment to 21 days after the last dose administrate
|
Cmax after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
|
From enrollment to 21 days after the last dose administrate
|
Multiple sets of Cmin
Tidsramme: From enrollment to 21 days after the last dose administrate
|
Cmin after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
|
From enrollment to 21 days after the last dose administrate
|
Multiple sets of AUC0-t
Tidsramme: From enrollment to 21 days after the last dose administrate
|
AUC0-t after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
|
From enrollment to 21 days after the last dose administrate
|
Multiple sets of AUCtau
Tidsramme: From enrollment to 21 days after the last dose administrate
|
AUCtau after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
|
From enrollment to 21 days after the last dose administrate
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Multiple sets of Tmax
Tidsramme: From enrollment to 21 days after the last dose administrate
|
Tmax after the first administration and the third administration in the three-week administration group and the seventh administration in the one-week administration group.
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From enrollment to 21 days after the last dose administrate
|
Safety index
Tidsramme: From enrollment to 30 days after the last dose administrate
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Adverse Events during the test
|
From enrollment to 30 days after the last dose administrate
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BOR
Tidsramme: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
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Record the proportion of CR and PR in all subjects
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From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
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DCR
Tidsramme: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
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CR/PR/SD accounted for the proportion of all subjects
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From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
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OS
Tidsramme: From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
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Overall Survival of all subjects
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From enrollment to death(for any reason),Until 24 months after the last subject left the administration group
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Immunogenicity index
Tidsramme: From enrollment to 21 days after the last dose administrate
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ADA
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From enrollment to 21 days after the last dose administrate
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
4. januar 2021
Primær fullføring (Forventet)
30. desember 2022
Studiet fullført (Forventet)
30. desember 2022
Datoer for studieregistrering
Først innsendt
3. september 2021
Først innsendt som oppfylte QC-kriteriene
11. november 2021
Først lagt ut (Faktiske)
23. november 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. november 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. november 2021
Sist bekreftet
1. november 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SSGJ-302H-mBC-IIT-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
The data will be shared from the trial begin for 10 years
IPD-delingstidsramme
From the trial begin for 10 years
Tilgangskriterier for IPD-deling
Every one
IPD-deling Støtteinformasjonstype
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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