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INHIBITOR: Retrospective Study Of Patients With Renal Cell Carcinoma And Mantle Cell Lymphoma Treated With Temsirolimus

25. mars 2016 oppdatert av: Pfizer

Inhibitor - Estudio Retrospectivo De Casos Clinicos De Pacientes Con Carcinoma De Celulas Renales Y Con Linforma De Celulas Del Manto Tratados Con Temsirolimus

The principal objective of the study is to evaluate the efficacy and safety of temsirolimus use in patients with Renal Cell Carcinoma and Mantle Cell Lymphoma.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

There is not sampling method

Studietype

Observasjonsmessig

Registrering (Faktiske)

243

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
      • A Coruña, Spania, 15006
        • Complexo Hospitalario Universitario A Coruña
      • Avila, Spania, 05004
        • Complejo AAsistencial de Avilla
      • Barcelona, Spania, 08035
        • Hospital Vall d'hebrón
      • Barcelona, Spania, 08025
        • Hospital de La Santa Creu i Sant Pau
      • Barcelona, Spania, 8940
        • Hospital Del Mar
      • La Coruña, Spania, 15006
        • Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera
      • Madrid, Spania, 28046
        • Hospital Universitario La Paz
      • Madrid, Spania, 28007
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spania, 28033
        • MD Anderson Cancer Center
      • Madrid, Spania, 28050
        • Hospital de Madrid Norte - Sanchinarro
    • Asturias
      • Oviedo, Asturias, Spania, 33006
        • Hospital Universitario Central de Asturias
    • Gijon
      • Cabueñes, Gijon, Spania, 33394
        • Hospital de Cabueñes
    • La Coruña
      • Santiago de Compostela, La Coruña, Spania, 15706
        • Hospital Clinico Universitario
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spania, 35016
        • Complejo Hospitalario Materno-Infantil Insular de Las Palmas
    • Navarra
      • Pamplona, Navarra, Spania, 31008
        • Hospital de Navarra
    • Valencia
      • Castellon, Valencia, Spania, 12002
        • Hospital Provincial de Castellon

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.

Beskrivelse

Inclusion Criteria:

Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.

Exclusion Criteria:

Patients that do not have a minimum (pre-specified) of data in their clinical record.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Patients that received treatment with Temsirolimus
Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.
Annen: Temsirolimus (Non-Interventional Study)
There is not any intervention in this study.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-free Survival (PFS)
Tidsramme: From initiation of treatment up to disease progression (up to 80 months)
Progression-free survival: interval between start of treatment to first day when progressive disease (PD) was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) for participants with RCC and Cheson criteria for participants with MCL, or death due to any cause. RECIST criteria: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Appearance of one or more new lesions also considered progression. Cheson criteria: appearance of any new sites of lymphoma OR at least 50% increase in product of longest perpendicular dimensions of any previously identified lymph node mass (LNM) OR at least 50% increase in longest dimension of any previously identified LNM greater than 1 cm in longest transverse dimension OR at least 50% increase in size of any previously involved site of lymphoma.
From initiation of treatment up to disease progression (up to 80 months)
Percentage of Participants With Objective Response
Tidsramme: From initiation of treatment up to disease progression (up to 80 months)
Objective response: percentage of participants who achieved complete remission (CR) or partial response (PR). RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. RECIST criteria (CR: disappearance of all target lesions, any pathological lymph nodes(target or non-target) reduced in short axis to <10 mm, PR: at least 30% decrease in sum of diameters of target lesions). Cheson criteria (CR: all lymph node masses regressed to normal size, each lymph node mass that was >1.5 cm in longest transverse dimension regressed to <=1.5 cm, lymph node mass that was 1.1-1.5 cm regressed to <=1 cm, complete disappearance of all radiographic evidence of disease, PR: at least 50% decrease in sum of products of the longest perpendicular dimensions of the previously identified dominant lymph node masses, no increase in size of other lymph nodes.)
From initiation of treatment up to disease progression (up to 80 months)
Duration of Response (DOR)
Tidsramme: From initiation of treatment up to disease progression (up to 80 months)
Duration of response (DOR) was defined as the interval from the date the response was documented to the first date that progression of disease (PD) was observed in participants with PR or CR. RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. PD, CR and PR are defined in primary outcome 1 and 2.
From initiation of treatment up to disease progression (up to 80 months)
Overall Survival (OS)
Tidsramme: From initiation of treatment untill death (up to 80 months)
Overall survival (OS) was defined as the interval from the day of the start of the treatment to death, or censored to the last date when the participant was identified to be alive.
From initiation of treatment untill death (up to 80 months)
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline to the 28 calendar days after the last administration of study drug (upto 80 months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events (Non-SAEs).
Baseline to the 28 calendar days after the last administration of study drug (upto 80 months)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

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 2011

Primær fullføring (Faktiske)

1. april 2015

Studiet fullført (Faktiske)

1. april 2015

Datoer for studieregistrering

Først innsendt

3. juni 2011

Først innsendt som oppfylte QC-kriteriene

6. juni 2011

Først lagt ut (Anslag)

7. juni 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

27. april 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. mars 2016

Sist bekreftet

1. mars 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • B1771017
  • INHIBITOR (Annen identifikator: Alias Study Number)

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