A Study of LY2875358 in Participants With MET Positive, Advanced Gastric Cancer
A Non-Randomized, Open-Label, Single-Arm, Phase 2 Study of LY2875358 in Patients With MET Diagnostic Positive, Advanced Gastric Cancer
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Faza
Faza
- Faza 2
Kontakty i lokalizacje
Lokalizacje studiów
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Aichi, Japonia, 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, Japonia, 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, Republika Korei, 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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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: LY2875358
LY2875358 will be administered intravenously (IV) at 2000 milligram (mg) bi-weekly in 28 day Cycle.
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Administrowany IV
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
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Progression Free Survival (PFS) Rate
Ramy czasowe: 8 Weeks
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8 Weeks
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
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Proportion of Participants who Exhibit Confirmed Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
Ramy czasowe: 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])
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 15007
- I4C-JE-JTBE (Inny identyfikator: Eli Lilly and Company)
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