A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer
30. juli 2019 oppdatert av: Eli Lilly and Company
Disposition of [¹⁴C]LY2606368 Following Intravenous Administration in Patients With Advanced and/or Metastatic Solid Tumours
The main purpose of this study is to evaluate the safety of the study drug known as Prexasertib (LY2606368) in participants with advanced cancer or cancer that has spread to other parts of the body.
This study will involve a single dose of ¹⁴C radiolabelled Prexasertib .
This means that a radioactive substance, carbon 14, will be incorporated into the study drug.
This will provide information about the study drug and its breakdown products and will help determine how much passes from the blood into urine, feces and expired air.
After a minimum 14-day washout period following the [¹⁴C] Prexasertib dose, participants will be allowed to receive continued access to Prexasertib as outpatients.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
6
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Liverpool, Storbritannia
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
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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:
- Have a histological or cytological diagnosis of cancer (solid tumour), with clinical or radiologic evidence of locally advanced and/or metastatic disease, for which no life-prolonging therapy exists
- Have the presence of measurable and/or nonmeasurable disease as defined by the Response Evaluation Criteria In Solid Tumours
- Have Body Surface Area (BSA) greater than or equal to (≥)1.62 meter squared (m²) and less than or equal to (≤) 1.90 m²
- Have adequate organ function
- Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have an estimated life expectancy, in the judgment of the investigator, that will permit the participant to complete 1 full cycle of treatment (beyond the initial [¹⁴C]prexasertib dose)
Exclusion Criteria:
- Have received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device
- Have serious pre-existing medical conditions (left to the discretion of the investigator)
- Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required)
- Have current haematologic malignancies or acute or chronic leukaemia
- Have an active fungal, bacterial, and/or known viral infection
- Have participated in a ¹⁴C (carbon) study within the last 6 months prior to screening for this study
- Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: [¹⁴C]Prexasertib
170 milligrams (mg) of prexasertib containing approximately 50 μCi [¹⁴C] prexasertib radiotracer administered intravenously (IV) as a 1 hour continuous IV infusion.
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Administered IV Infusion
Andre navn:
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Eksperimentell: Prexasertib
105 milligrams per square meter (mg/m²) of prexasertib administered IV as a 1 hour continuous IV infusion once every 14 days (14 day cycles). Treatment may continue until discontinuation criteria are met. Treatment for this arm was administered after ¹⁴C administration (¹⁴C was administered during first phase of the study) |
Administered IV Infusion
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Urinary Excretion of LY2606368 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Tidsramme: Baseline through 120 hours after administration of study drug
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Baseline through 120 hours after administration of study drug
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Fecal Excretion of LY2606368 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Tidsramme: Baseline through 120 hours after administration of study drug
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Baseline through 120 hours after administration of study drug
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LY2606368 Radioactivity in Expired Air Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Tidsramme: Baseline through 120 hours after administration of study drug
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Baseline through 120 hours after administration of study drug
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Pharmacokinetics: Maximum Concentration (Cmax) of LY2606368 and Radioactivity
Tidsramme: Predose through 120 hours after administration of study drug
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Predose through 120 hours after administration of study drug
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Pharmacokinetics: Area Under the Concentration Time Curve from Time Zero to the Last Measured Concentration (AUC0-tlast) of LY2606368 and Radioactivity
Tidsramme: Predose through 120 hours after administration of study drug
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Predose through 120 hours after administration of study drug
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Pharmacokinetics: Area Under the Concentration Time Curve from Time Zero to Infinity (AUC0-∞) of LY2606368 and Radioactivity
Tidsramme: Predose through 120 hours after administration of study drug
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Predose through 120 hours after administration of study drug
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Relative Abundance of LY2606368 As Measured by Percentage of Radioactivity in Feces and Urine
Tidsramme: Baseline through 120 hours after administration of study drug
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Baseline through 120 hours after administration of study drug
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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.
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
22. september 2016
Primær fullføring (Faktiske)
29. april 2017
Studiet fullført (Faktiske)
27. juli 2017
Datoer for studieregistrering
Først innsendt
18. mai 2016
Først innsendt som oppfylte QC-kriteriene
18. mai 2016
Først lagt ut (Anslag)
19. mai 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. august 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. juli 2019
Sist bekreftet
1. juli 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 15556
- I4D-EW-JTJG (Annen identifikator: Eli Lilly and Company)
- 2015-003126-13 (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. .