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A Phase I Study of ABT-888 in Combination With Conventional Whole Brain Radiation Therapy (WBRT) in Cancer Patients With Brain Metastases

17. november 2017 opdateret af: AbbVie (prior sponsor, Abbott)

A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of ABT-888 in Combination With Whole Brain Radiation Therapy in Subjects With Brain Metastases

This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given together with Whole Brain Radiation Therapy (WBRT) in treating patients with brain metastases.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a Phase 1, multicenter, dose-escalation study evaluating the safety, tolerability and pharmacokinetics of the PARP inhibitor ABT-888 in combination with conventional whole brain radiation therapy (WBRT) in the treatment of subjects with solid tumors metastatic to the brain.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

80

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
      • Toronto, Canada, M5G 2M9
        • Site Reference ID/Investigator# 18542
  • Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Site Reference ID/Investigator# 8334
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Site Reference ID/Investigator# 52462
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Site Reference ID/Investigator# 24483
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21231-2410
        • Site Reference ID/Investigator# 7180
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202-2689
        • Site Reference ID/Investigator# 19021
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19111
        • Site Reference ID/Investigator# 6344
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • Site Reference ID/Investigator# 6653
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Site Reference ID/Investigator# 46322

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:

  • Age is greater than or equal to 18 years.
  • Histologically or cytologically confirmed non-CNS primary solid malignancy.
  • Pathologically or radiographically confirmed metastatic disease in the brain. Subjects with non-measurable lesions, including leptomeningeal carcinomatosis, are eligible.
  • WBRT is clinically indicated, with the exception of prophylactic treatment.
  • Karnofsky Performance Status (KPS) greater than or equal to a score of 70.
  • Adequate hematology, renal and hepatic function.

  • Both men and women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and up to 2 months following completion of protocol therapy.

    • Total abstinence from sexual intercourse (minimum one complete menstrual cycle)
    • A vasectomized partner * Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration
    • Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream)
  • Subject is capable of understanding and complying with parameters as outlined in the protocol.
  • Subject or the subject's legally acceptable representative has voluntarily signed and dated the informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria:

  • Brain metastases secondary to germ cell tumor or lymphoma malignancy.
  • Primary central nervous system (CNS) neoplasm.

  • Prior or concurrent administration of the following therapies or treatments:

    • Prior treatment with WBRT
    • SRS performed less than 14 days prior to WBRT D1, or is scheduled to occur within 30 days of the last WBRT session
    • Last dose of chemotherapy, immunotherapy, biologic therapy, or investigational therapy was less than 14 days prior to WBRT D1. Bisphosphonates, hormone modification therapy, and trastuzumab are permitted without restriction
  • Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment.
  • Known seizure disorder (status epileptics) that is uncontrolled, or seizures occurring greater than or equal to 3 times a week over the past month.
  • If female, subject is pregnant or breast-feeding.

  • Clinically significant and uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or neurological/psychiatric disease or disorder, including but not limited to:

    • Active uncontrolled infection
    • Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
    • Any other illness condition(s) that could exacerbate potential toxicities, confound safety assessments, require excluded therapy for management, or limit compliance with study requirements
  • Unable to swallow and retain oral medications.

  • Known contraindication to enhanced MRI and CT, including but not limited to:

    • Presence of metal objects within the body such as a cardiac pacemaker, implanted cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or shrapnel
    • History of immediate or delayed hypersensitivity reaction or other contraindication to contrast agents including but not limited to gadolinium and iodine
  • Previous enrollment in this study or another study involving the investigation of ABT-888, with the exception of receiving a single dose of study drug.
  • Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-888 and/or WBRT.

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: 1

This is an open label study; therefore, there are no numbered/labeled study arms.

This is a dose escalation study, ABT-888 dose will be escalated in conjunction with two schedules of whole brain radiation therapy (WBRT). Subjects may be treated WBRT for 3 weeks (15 days) or 2 weeks (10 days).
Medicin: ABT-888
Oral Capsules
Andre navne:
  • veliparib
Stråling: Whole Brain Radiation Therapy
15 fractions of 2.5 Gy over 3 weeks to a total dose of 37.5 GY or 10 fractions of 3.0 Gy over 2 weeks to a total dose of 30 Gy
Andre navne:
  • WBRT

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Determine the maximum tolerated dose of ABT-888 in combination with whole brain radiation therapy
Tidsramme: ABT-888 will be dose escalated until the largest dose is reached that is felt to be safe based on safety information from all subjects.
ABT-888 will be dose escalated until the largest dose is reached that is felt to be safe based on safety information from all subjects.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety Assessment Physical and Neurological Exam
Tidsramme: be performed at all study visits, final and follow-up visit
be performed at all study visits, final and follow-up visit
Safety Assessment Mini-Mental State Examination
Tidsramme: be performed at all study visits, final and follow-up visit
be performed at all study visits, final and follow-up visit
Safety Assessment Laboratory testing
Tidsramme: be performed at all study visits, final and follow-up visit
Chemistry and Hematology labs will be collected
be performed at all study visits, final and follow-up visit

Samarbejdspartnere og efterforskere

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

Sponsor

AbbVie (prior sponsor, Abbott)

Efterforskere

  • Studieleder: Shepherd L Stacie, 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

1. marts 2008

Primær færdiggørelse (Faktiske)

1. marts 2013

Studieafslutning (Faktiske)

1. marts 2013

Datoer for studieregistrering

Først indsendt

28. marts 2008

Først indsendt, der opfyldte QC-kriterier

28. marts 2008

Først opslået (Skøn)

1. april 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. november 2017

Sidst verificeret

1. maj 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • M10-128

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 .

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