A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer
30. juli 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
6
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Liverpool, Det Forenede Kongerige
- 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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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: [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 navne:
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Eksperimentel: 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 navne:
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Hvad måler undersøgelsen?
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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.
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
22. september 2016
Primær færdiggørelse (Faktiske)
29. april 2017
Studieafslutning (Faktiske)
27. juli 2017
Datoer for studieregistrering
Først indsendt
18. maj 2016
Først indsendt, der opfyldte QC-kriterier
18. maj 2016
Først opslået (Skøn)
19. maj 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. august 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. juli 2019
Sidst verificeret
1. juli 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 15556
- I4D-EW-JTJG (Anden identifikator: Eli Lilly and Company)
- 2015-003126-13 (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 .