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D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours

25. august 2017 opdateret af: AstraZeneca

A Two-part, Randomised, Open-label, Multicentre, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of Olaparib Following Single 400 mg Doses of the Capsule Formulation in Patients With Advanced Solid Tumours.

This is a 2 part study for patients with solid tumours. The purpose of Part A is to measure the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after eating 3 different breakfasts (high calorie, regular and none). In Part B Patients can take olaparib capsules daily and study assessments will be recorded for 6 months (minimum). Treatment can continue for as long as the patient is benefitting. Throughout the study patients will be monitored for any side effects.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

32

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Edegem, Belgien, 2650
        • Research Site
      • Leuven, Belgien, 3000
        • Research Site
      • Wilrijk, Belgien, 2610
        • Research Site
  • Det Forenede Kongerige
      • Glasgow, Det Forenede Kongerige, G12 0YN
        • Research Site
      • Manchester, Det Forenede Kongerige, M20 4BX
        • Research Site
  • Holland
      • Amsterdam, Holland, 1081 HV
        • Research Site
      • Maastricht, Holland, 6202 AZ
        • Research Site

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 130 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients aged ≥18 years, male and female
  • Able to eat a high-fat breakfast within a 30-minute period, as provided by the study site
  • Histologically or, where appropriate, cytologically confirmed malignant solid tumour refractory or resistant to standard therapy and for which no suitable effective standard therapy exists
  • ECOG performance status ≤2
  • Normal organ and bone marrow function measured within 28 days prior to administration of IP as defined in protocol

Exclusion Criteria:

  • Participation in another clinical study with an IP during the last 14 days (or a longer period depending on the defined characteristics of the agents used)
  • Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 2 weeks prior to study treatment (or a longer period depending on the defined characteristics of the agents used).
  • Toxicities (≥CTCAE Grade 2) caused by previous cancer therapy, excluding alopecia
  • Patients unable to fast for up to 14 hours or who have type I or type II diabetes
  • Patients who have gastric, gastro-oesophageal or oesophageal cancer

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Fasted
Olaparib capsules following no breakfast
Medicin: Olaparib
400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.
Andet: Dietary Fasted
Allocated breakfast prior to dosing with 400mg olaparib capsules
Andet: Standard meal
Olaparib capsules after standard breakfast
Medicin: Olaparib
400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.
Andet: Dietary standard
Allocated breakfast prior to dosing with 400mg olaparib capsules
Andet: High Fat
Olaparib capsules after high fat breakfast
Medicin: Olaparib
400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.
Andet: Dietary High Fat
Allocated breakfast prior to dosing with 400mg olaparib capsules

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pharmacokinetics of Olaparib (Cmax and tmax)
Tidsramme: Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose
Rate and extent of absorption of olaparib following single-dose olaparib by assessment of maximum plasma olaparib concentration (Cmax) and time to reach maximum plasma concentration (tmax)
Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose
Pharmacokinetics of Olaparib (AUC0-t)
Tidsramme: Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose.
Rate and extent of absorption of olaparib following single-dose olaparib by assessment of area under the plasma concentration time curve from zero to the last measurable time point (AUC0-t)
Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose.
Pharmacokinetics of Olaparib (AUC)
Tidsramme: Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose
Rate and extent of absorption of olaparib following single-dose olaparib by assessment of area under the plasma concentration time curve from zero to infinity (AUC)
Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose
Pharmacokinetics of Olaparib Pharmacokinetics of Olaparib (CL/F, Vz/F, λz and t½)
Tidsramme: Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose.
Rate and extent of absorption of olaparib following single-dose olaparib by assessment of apparent clearance following oral administration (CL/F), apparent volume of distribution (Vz/F), terminal rate constant (λz), and terminal half-life (t½)
Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety monitoring of Olaparib
Tidsramme: AEs will be collected from signed informed consent up to 30-day post last dose in Part A. For patients in Part B, AE's will be collected until the final patient has completed 6 months in Part B, including 30 day follow up for those who discontinue
Assessment of adverse events (AEs), graded by CTCAE (v4.0), physical examination, vital signs (including BP and pulse), standard 12-lead ECG and evaluation of laboratory parameters (clinical chemistry, haematology, and urinalysis). Assessment of physical examination, vital signs, ECG and evaluation of laboratory parameters will occur at screening, on the day before dosing in each treatment period and 30 days after last dose.
AEs will be collected from signed informed consent up to 30-day post last dose in Part A. For patients in Part B, AE's will be collected until the final patient has completed 6 months in Part B, including 30 day follow up for those who discontinue

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

Efterforskere

  • Studieleder: Anitra Fielding, AstraZeneca Senior Research Physician
  • Ledende efterforsker: Christian Rolfo, UZ Antwerpen
  • Studiestol: Wendy Bannister, AstraZeneca Study Statistician

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.

Hjælpsomme links

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)

4. juli 2013

Primær færdiggørelse (Faktiske)

18. oktober 2013

Studieafslutning (Faktiske)

6. juni 2017

Datoer for studieregistrering

Først indsendt

8. maj 2013

Først indsendt, der opfyldte QC-kriterier

8. maj 2013

Først opslået (Skøn)

10. maj 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. august 2017

Sidst verificeret

1. august 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D081AC00001
  • 2013-001255-13 (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 Faste tumorer

Kliniske forsøg med Olaparib

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Brazil

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner