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Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme

17. november 2017 opdateret af: AbbVie

A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme

This study is evaluating the safety and pharmacokinetics of ABT-414 in subjects with glioblastoma multiforme.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

202

Fase

  • Fase 1

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Glioblastoma Multiforme (GBM)
  2. 70 or above on Karnofsky Performance Status
  3. Adequate bone marrow function
  4. Recurrent GBM per RANO criteria
  5. Subjects must have confirmed EGFR amplification by central lab

Exclusion Criteria:

  1. For Subjects with recurrent GBM in Arm B, subject has received prior treatment with bevacizumab, nitrosourea, or has secondary GBM
  2. For Subjects with recurrent GBM in Arm C, subject has received prior treatment with bevacizumab, or has secondary GBM
  3. Allergies to temozolomide, dacarbazine, IgG containing agents
  4. Anti-cancer treatment 28 days prior to study Day 1, except in Arm B expanded cohort temozolomide therapy is allowed
  5. Subjects that have had more than one disease recurrence

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A
ABT-414 in combination with radiation and temozolomide
Medicin: ABT-414
ABT-414 vil blive administreret ved intravenøs infusion
Andre navne:
  • Depatuxizumab Mafodotin
Medicin: Temozolomide
Temozolomide will be administered per label and local prescribing regulations.
Stråling: Whole Brain Radiation
Whole Brain radiation will be administered in 30 fractions.
Eksperimentel: Arm B
ABT-414 in combination with temozolomide
Medicin: ABT-414
ABT-414 vil blive administreret ved intravenøs infusion
Andre navne:
  • Depatuxizumab Mafodotin
Medicin: Temozolomide
Temozolomide will be administered per label and local prescribing regulations.
Eksperimentel: Arm C
ABT-414 monotherapy
Medicin: ABT-414
ABT-414 vil blive administreret ved intravenøs infusion
Andre navne:
  • Depatuxizumab Mafodotin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number and percentage of participants with adverse events
Tidsramme: Every week for an expected average of 34 weeks
Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)
Every week for an expected average of 34 weeks
Maximum concentration of ABT-414
Tidsramme: Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Measurement of the maximum concentration of ABT- 414 in the blood
Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Number of Dose Limiting Toxicities
Tidsramme: Every week for an expected average of 34 weeks
Measurement by clinical lab results, vital signs, physical exam, and electrocardiogram (ECG)
Every week for an expected average of 34 weeks
Minimum Concentration of ABT-414
Tidsramme: Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Measurement of the minimum concentration of ABT-414 in the blood
Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Half-life of ABT-414
Tidsramme: Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks
Measurement of the clearance of ABT-414
Multiple time points in Cycles 1, 2, and 3 (4 weeks each) and Day 1 of remaining cycles until end of treatment, an expected average of 34 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Biomarker EGFR expression
Tidsramme: At screening and post-study
Assessment of tumor biomarkers that may correlate with efficacy.
At screening and post-study
Progression Free Survival
Tidsramme: Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or the participant becomes lost to follow up, or study termination.
Progression Free Survival per RANO criteria is the length of time during and after the treatment of a disease, that the participant lives with the disease but does not get worse.
Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or the participant becomes lost to follow up, or study termination.
Overall Survival
Tidsramme: Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or participant becomes lost to follow up, or study termination
The overall response rate will be evaluated every 8 weeks at each assessment of disease according to RANO criteria, up to 28 months
Multiple time points in each cycle, throughout study, and survival information monthly until 1 year after last visit, or participant becomes lost to follow up, or study termination

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AbbVie

Efterforskere

  • Studieleder: Earle Bain, MD, AbbVie

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. april 2013

Primær færdiggørelse (Faktiske)

19. juni 2017

Studieafslutning (Faktiske)

19. juni 2017

Datoer for studieregistrering

Først indsendt

5. februar 2013

Først indsendt, der opfyldte QC-kriterier

26. februar 2013

Først opslået (Skøn)

28. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. november 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • M12-356
  • 2012-003884-23 (EudraCT nummer)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Glioblastoma Multiforme

Kliniske forsøg med ABT-414

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Paraguay

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner