- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02536586
A Study of LY3023414 in Japanese Participants With Advanced Cancer
20 juli 2018 uppdaterad av: 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.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
12
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Number of Participants with LY3023414 Dose-Limiting Toxicities (DLT)
Tidsram: Cycle 1 (21 days)
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Cycle 1 (21 days)
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Sekundära resultatmått
Resultatmått |
Tidsram |
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Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve (AUC) of LY3023414
Tidsram: 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
Tidsram: 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])
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2015
Primärt slutförande (Faktisk)
9 februari 2017
Avslutad studie (Faktisk)
9 februari 2017
Studieregistreringsdatum
Först inskickad
28 augusti 2015
Först inskickad som uppfyllde QC-kriterierna
28 augusti 2015
Första postat (Uppskatta)
1 september 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 juli 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 juli 2018
Senast verifierad
1 juli 2018
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 15838
- I6A-JE-CBBH (Annan identifierare: Eli Lilly and Company)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .