A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression
23. juli 2014 oppdatert av: Hoffmann-La Roche
An Open-label Pilot Study of Herceptin Monotherapy on Objective Treatment Response in Patients With Metastatic or Locally Advanced Gastric Cancer Who Had Disease Progression During Platinum-based or 5-fluoropyrimidine-based Chemotherapy
This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or advanced gastric cancer with disease progression during platinum-based or 5-fluoropyrimidine-based chemotherapy.
The anticipated time on study treatment is until disease progression.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
6
Fase
- Fase 2
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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Dresden, Tyskland, 01307
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Erlangen, Tyskland, 91054
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Essen, Tyskland, 45122
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Grenzach-wyhlen, Tyskland, 79639
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Halle, Tyskland, 06120
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Kassel, Tyskland, 34125
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Kiel, Tyskland, 24105
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Mannheim, Tyskland, 68167
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München, Tyskland, 81675
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München, Tyskland, 81377
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Oldenburg, Tyskland, 26133
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Wien, Østerrike, 1090
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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 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- adult patients 18-75 years of age;
- metastatic or advanced gastric cancer;
- disease progression under or after 1 prior platinum-based or 5-fluoropyrimidine-based chemotherapy for metastatic disease;
- >=4 weeks from last platinum-based or fluoropyrimidine-based chemotherapy;
- >=1 measurable lesion;
- HER2 overexpression (IHC [2+] or [3+]).
Exclusion Criteria:
- concurrent chemotherapy or immunotherapy;
- brain or meningeal metastases;
- clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
- co-existing malignancies or malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ;
- women who are pregnant or breastfeeding.
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: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Trastuzumab Monotherapy
Initial dose of 4 milligrams (mg) per (/) kilogram (kg) by body weight (BW), followed by 2 mg/kg BW at each subsequent visit
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4 mg/kg initial dose, followed by 2 mg/kg
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category
Tidsramme: Weekly throughout study
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Tumor response assessed according to RECIST.
Complete response (CR): complete disappearance of all target and non-target lesions, with exception of nodal disease.
All nodes, both target and non-target, must decrease to normal (short axis less than [<]10 millimeters [mm]); no new lesions.
Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of sum of diameters of all target lesions.
Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.
Stable disease (SD): not qualifying for CR, PR, or progressive disease (PD).
Participants who could not be classified per RECIST were allocated as follows: early death from malignant disease (death due to cancer), early death because of other cause (death not related to toxicity or cancer disease), and unknown (for not fitting into the above categories).
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Weekly throughout study
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Percentage of Participants With Clinical Benefit
Tidsramme: Weekly throughout the study
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Participants were classified as having a clinical benefit if they had a best overall tumor response of CR, PR, or SD.
Tumor response assessed according to RECIST.
CR: complete disappearance of all target and non-target lesions, with exception of nodal disease.
All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions.
PR: ≥30% decrease under baseline of sum of diameters of all target lesions.
Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.
Stable SD: not qualifying for CR, PR, or PD.
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Weekly throughout the study
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Percentage of Participants With a Best Overall Response of CR or PR
Tidsramme: Weekly throughout the study
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Tumor response assessed according to RECIST.
CR: complete disappearance of all target and non-target lesions, with exception of nodal disease.
All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions.
PR: ≥30% decrease under baseline of sum of diameters of all target lesions.
Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.
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Weekly throughout the study
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Overall Survival - Number of Participants Who Died
Tidsramme: Weekly throughout the study
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OS was defined as the time, in months, from the date of study entry to the date of the death due to any cause.
If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
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Weekly throughout the study
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Overall Survival
Tidsramme: Weekly throughout the study
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Overall survival (OS) was defined as the time, in months, from the date of study entry to the date of the death due to any cause.
If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
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Weekly throughout the study
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Time to Progression - Number of Participants With an Event
Tidsramme: Weekly throughout the study
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Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause.
If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
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Weekly throughout the study
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Time to Progression
Tidsramme: Weekly throughout the study
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Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause.
If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
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Weekly throughout the study
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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
1. januar 2004
Primær fullføring (Faktiske)
1. februar 2008
Studiet fullført (Faktiske)
1. februar 2008
Datoer for studieregistrering
Først innsendt
4. desember 2013
Først innsendt som oppfylte QC-kriteriene
4. desember 2013
Først lagt ut (Anslag)
9. desember 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. august 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juli 2014
Sist bekreftet
1. juli 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Patologiske prosesser
- Neoplasmer
- Neoplasmer etter nettsted
- Sykdomsattributter
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Magesykdommer
- Sykdomsprogresjon
- Neoplasmer i magen
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Trastuzumab
Andre studie-ID-numre
- ML17263
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. .