- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01874938
A Study of LY2875358 in Participants With MET Positive, Advanced Gastric Cancer
7 janvier 2015 mis à jour par: 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.
Aperçu de l'étude
Type d'étude
Interventionnel
Inscription (Réel)
15
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Seoul, Corée, République de, 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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Aichi, Japon, 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, Japon, 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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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: LY2875358
LY2875358 will be administered intravenously (IV) at 2000 milligram (mg) bi-weekly in 28 day Cycle.
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Administré IV
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Progression Free Survival (PFS) Rate
Délai: 8 Weeks
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8 Weeks
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Proportion of Participants who Exhibit Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Délai: 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])
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 août 2013
Achèvement primaire (Réel)
1 août 2014
Achèvement de l'étude (Réel)
1 décembre 2014
Dates d'inscription aux études
Première soumission
22 mai 2013
Première soumission répondant aux critères de contrôle qualité
7 juin 2013
Première publication (Estimation)
11 juin 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
16 janvier 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 janvier 2015
Dernière vérification
1 janvier 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 15007
- I4C-JE-JTBE (Autre identifiant: Eli Lilly and Company)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .