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D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours

25. august 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

32

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiesteder

  • Belgia
      • Edegem, Belgia, 2650
        • Research Site
      • Leuven, Belgia, 3000
        • Research Site
      • Wilrijk, Belgia, 2610
        • Research Site
  • Nederland
      • Amsterdam, Nederland, 1081 HV
        • Research Site
      • Maastricht, Nederland, 6202 AZ
        • Research Site
  • Storbritannia
      • Glasgow, Storbritannia, G12 0YN
        • Research Site
      • Manchester, Storbritannia, M20 4BX
        • Research Site

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 til 130 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

AstraZeneca

Etterforskere

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

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 (Faktiske)

4. juli 2013

Primær fullføring (Faktiske)

18. oktober 2013

Studiet fullført (Faktiske)

6. juni 2017

Datoer for studieregistrering

Først innsendt

8. mai 2013

Først innsendt som oppfylte QC-kriteriene

8. mai 2013

Først lagt ut (Anslag)

10. mai 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. august 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2017

Sist bekreftet

1. august 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D081AC00001
  • 2013-001255-13 (EudraCT-nummer)

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