- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02536586
A Study of LY3023414 in Japanese Participants With Advanced Cancer
20. juli 2018 opdateret af: Eli Lilly and Company
A Phase 1 Study of LY3023414 in Japanese Patients With Advanced Malignancies
The main purpose of this study is to evaluate the tolerability of an investigational drug known as LY3023414 in Japanese participants with advanced cancer or cancer that has spread to another part(s) of the body.
The study will also explore the safety of the drug.
It will measure how much of the drug gets into the blood steam and how long the body takes to get rid of it.
It will investigate anti-cancer activity.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
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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Chiba, Japan, 277 8577
- 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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Tokyo, Japan, 104-0045,
- 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
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria
- Have histological or cytological evidence of a diagnosis of solid tumor that is advanced and/or metastatic and must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed or for whom standard therapy would not be appropriate.
- Have the presence of measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Have adequate organ and coagulation function.
- Have discontinued all previous cancer therapies, and any agents that have not received regulatory approval for any indication, for at least 21 days or 5 half-lives prior to study treatment, whichever is shorter, and recovered from the acute effects of therapy. Participants must have discontinued mitomycin-C or nitrosourea therapy for at least 42 days.
- Are able to swallow capsules.
- Males must agree to use medically approved barrier contraceptive precautions during the study and for 3 months following the last dose of study drug.
- Females with childbearing potential: Must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug, must have had a negative serum or urine pregnancy test ≤7 days before the first dose of study drug.
- A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, breastfeeding must cease from the day of the first study drug administration until at least 3 months after the last administration.
Exclusion Criteria
- Have serious pre-existing medical conditions.
- Have symptomatic central nervous system malignancy or metastasis.
- Have known acute or chronic leukemia or current hematologic malignancies that, in the judgment of the investigator and sponsor, may affect the interpretation of results.
- Have a known active fungal, bacterial, and/or known viral infection.
- Intolerance to any previous treatment with any phosphatidylinositol 3-kinase (PI3K)/AKT/mammalian target of rapamycin (mTOR) inhibitor. Treatment with any PI3K/AKT/mTOR inhibitor must have discontinued for at least 21 days or 5 half-lives prior to first study drug administration, whichever is shorter, and participants must have recovered from the acute effects of therapy.
- Have a second primary malignancy that, in the judgment of the investigator, and sponsor may affect the interpretation of results.
- Participants with active alcohol abuse, as determined by the investigator.
- Have a history of heart failure according to New York Heart Association Class ≥3.
- Have corrected QT (QTc) interval of >470 milliseconds (msec) on screening electrocardiogram (ECG).
- Have insulin-dependent diabetes mellitus or a history of gestational diabetes mellitus.
- Have any evidence of clinically active interstitial lung disease (ILD).
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: LY3023414
LY3023414 administered orally, twice daily in 21-day cycles.
Treatment will continue until disease progression, development of unacceptable toxicity, or other discontinuation criteria are met.
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LY3023414 administered orally.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Number of Participants with LY3023414 Dose-Limiting Toxicities (DLT)
Tidsramme: Cycle 1 (21 days)
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Cycle 1 (21 days)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve (AUC) of LY3023414
Tidsramme: Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.)
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Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.)
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Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3023414
Tidsramme: Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.)
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Predose Cycle 1 through predose Cycle 3. (Cycle = 21 days.)
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Proportion of Participants With Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR])
Tidsramme: Baseline through study completion (estimated as up to five months)
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Baseline through study completion (estimated as up to five months)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. september 2015
Primær færdiggørelse (Faktiske)
9. februar 2017
Studieafslutning (Faktiske)
9. februar 2017
Datoer for studieregistrering
Først indsendt
28. august 2015
Først indsendt, der opfyldte QC-kriterier
28. august 2015
Først opslået (Skøn)
1. september 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juli 2018
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 15838
- I6A-JE-CBBH (Anden identifikator: Eli Lilly and Company)
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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