- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01874938
A Study of LY2875358 in Participants With MET Positive, Advanced Gastric Cancer
7 januari 2015 uppdaterad av: Eli Lilly and Company
A Non-Randomized, Open-Label, Single-Arm, Phase 2 Study of LY2875358 in Patients With MET Diagnostic Positive, Advanced Gastric Cancer
The main purpose of this study is to evaluate the effectiveness of LY2875358 in participants with MET diagnostic positive (+), advanced gastric or gastroesophageal junction (GEJ) cancer.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
15
Fas
- Fas 2
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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Aichi, Japan, 464-8681
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Osaka, Japan, 565-0871
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Seoul, Korea, Republiken av, 135 720
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 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 a diagnosis of a histopathologically or cytologically confirmed local and/or advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma which is unresectable
- Have received 2 regimens of prior chemotherapies for gastric or GEJ adenocarcinoma
- Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- Have consent to provide a tissue sample for pre-screening
- Determined to be MET diagnostic positive based upon testing of a tumor sample obtained at any time before enrollment
- Have discontinued all previous treatments for cancer, including chemotherapy and radiotherapy, for at least 3 weeks before enrollment and have recovered from the acute effects of therapy
- Have adequate organ function
- Male participants: must agree to use a reliable method of birth control and to not donate sperm during the study and for at least 4 months following last dose of study drug or country requirements, whichever is longer
- Female participants: are women of child-bearing potential who test negative for pregnancy ≤14 days before enrollment based on a serum pregnancy test and agree to use a reliable method of birth control during the study and for 4 months following the last dose of the study drug and must also not be breastfeeding
- Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have an estimated life expectancy, in the judgment of the investigator, of at least 12 weeks
Exclusion Criteria:
- Are currently enrolled in, or discontinued within the last 21 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have previously completed or withdrawn from this study or any other study investigating LY2875358
- Have an active fungal, bacterial, and/or known viral infection
- Have a history of New York Heart Association class ≥3, unstable angina, myocardial infarction (MI) in 6 months prior to study drug administration
- Have symptomatic central nervous system (CNS) malignancy or metastasis
- Have previous or concurrent malignancies
- Have received a liver transplant, or have liver cirrhosis with a Child-Pugh Stage of B or C
- Have corrected QT interval (QTc) of >470 millisecond (msec) on screening electrocardiogram (ECG)
- Have received previous treatment with any hepatocyte growth factor (HGF)/MET targeting therapeutics
- Have a history of radiation therapy involving more than 25% of the bone marrow. Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation
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: LY2875358
LY2875358 will be administered intravenously (IV) at 2000 milligram (mg) bi-weekly in 28 day Cycle.
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Administreras IV
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Progression Free Survival (PFS) Rate
Tidsram: 8 Weeks
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8 Weeks
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Sekundära resultatmått
Resultatmått |
Tidsram |
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Proportion of Participants who Exhibit Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Tidsram: Baseline to Confirmed CR or PR (Estimated up to 4 Months)
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Baseline to Confirmed CR or PR (Estimated up to 4 Months)
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Proportion of Participants who Exhibit Stable Disease (SD) or Confirmed CR or PR (Disease Control Rate [DCR])
Tidsram: Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
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Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
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Duration of Response
Tidsram: Date of CR or PR to Date of Measured Recurrent or Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
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Date of CR or PR to Date of Measured Recurrent or Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
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Overall Survival (OS)
Tidsram: Baseline to Death from Any Cause (Estimated up to 6 Months)
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Baseline to Death from Any Cause (Estimated up to 6 Months)
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Pharmacokinetics (PK): Systemic Clearance (CL) of LY287358
Tidsram: Baseline to Study Completion (Estimated up to 4 Months)
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Baseline to Study Completion (Estimated up to 4 Months)
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Pharmacokinetics (PK): Volume of distribution (V) of LY287358
Tidsram: Baseline to Study Completion (Estimated up to 4 Months)
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Baseline to Study Completion (Estimated up to 4 Months)
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PFS
Tidsram: Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 6 Months)
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Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 6 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 augusti 2013
Primärt slutförande (Faktisk)
1 augusti 2014
Avslutad studie (Faktisk)
1 december 2014
Studieregistreringsdatum
Först inskickad
22 maj 2013
Först inskickad som uppfyllde QC-kriterierna
7 juni 2013
Första postat (Uppskatta)
11 juni 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 januari 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 januari 2015
Senast verifierad
1 januari 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 15007
- I4C-JE-JTBE (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 .