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A Rollover Study for Patients Who Participated in Other Romidepsin Protocols

14. november 2019 oppdatert av: Celgene

An Open Label, Single-Arm Rollover Study for Subjects Who Participated In Other Romidepsin Protocols

This study is intended to provide access to Romidepsin for participants who received Romidepsin in other trials sponsored by Gloucester Pharmaceuticals or Celgene Corporation and for participants whom the investigator feels may benefit from continuing treatment with Romidepsin.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Participants must have previously participated in a Romidepsin study sponsored by Gloucester Pharmaceuticals or Celgene Corporation.

Studietype

Intervensjonell

Registrering (Faktiske)

19

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Florida
      • Sarasota, Florida, Forente stater, 34232
        • Florida Cancer Specialists
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37203
        • Sarah Cannon Research Institute
  • Storbritannia
      • London, Storbritannia, W1G6AD
        • Sarah Cannon Research UK

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

Beskrivelse

Inclusion Criteria

  1. Previously participated in and fulfilled the inclusion and exclusion criteria in one of the romidepsin clinical trials: ROMI-ADVM-001 (NCT01324310), ROMI-ADVM-002 (NCT01324323). Additional studies added at the discretion of the medical monitor of the study
  2. Physician believes continued romidepsin treatment is of benefit to participant.
  3. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
  4. Able to adhere to the study visit schedule and other protocol requirements.
  5. Negative urine or serum pregnancy test for females of child bearing potential; and
  6. All females of child bearing potential must use an effective method of contraception (an intrauterine contraceptive device [IUCD] or double contraceptive method using condoms and a diaphragm plus spermicide) during the treatment period and for at least 1 month thereafter. Male participants should use contraception during the treatment period and for at least 3 months thereafter. Female participants should avoid the use of estrogen-containing contraceptives, since romidepsin may reduce the effectiveness of estrogen-containing contraceptives. An in vitro binding assay determined that romidepsin competes with β-estradiol for binding to estrogen receptors.

Exclusion Criteria

  1. Concomitant use of drugs that may cause a significant prolongation of the corrected measurement of the time between the start of cardiac Q wave and the end of the T wave (QTc) .
  2. Concomitant use of Cytochrome P 450 3A4 (CYP3A4) strong inhibitors within 1 week of trial medications.
  3. Concomitant use of therapeutic warfarin due to a potential drug interaction. Use of a low dose of warfarin or another anticoagulant to maintain patency of venous access port and cannulas is permitted.
  4. Prior chemotherapy or radiotherapy or any investigational agent after the last dose of romidepsin from the preceding romidepsin study.
  5. Participants who are pregnant or breast-feeding.

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Romidepsin
This study is an open-label, single-arm study. The study is divided into the Screening Period, Treatment Period, and Follow-up Period.
Legemiddel: Romidepsin
The participants will generally continue at the same dose, infusion time and frequency used for the last dose of romidepsin given in the preceding romidepsin study. If the participant entered this rollover study in the middle of a cycle, then the cycle number and cycle day will be carried over from the preceding romidepsin study.
Andre navn:
  • Istodax®, ROMI

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
Tidsramme: All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug; maximum drug exposure was 231 days
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4: On the following is the scale: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.
All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug; maximum drug exposure was 231 days

Samarbeidspartnere og etterforskere

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

Sponsor

Celgene

Samarbeidspartnere

Celgene Corporation

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)

1. mai 2011

Primær fullføring (Faktiske)

5. september 2012

Studiet fullført (Faktiske)

5. september 2012

Datoer for studieregistrering

Først innsendt

12. mai 2011

Først innsendt som oppfylte QC-kriteriene

13. mai 2011

Først lagt ut (Anslag)

16. mai 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. november 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. november 2019

Sist bekreftet

1. november 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ROMI-ADVM-004
  • 2010-023040-32 (EudraCT-nummer)

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. .

Abonnere