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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

Status

Avslutad

Betingelser

Intervention / Behandling

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

      • 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.
      • 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.
      • 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.

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
Experimentell: LY2875358
LY2875358 will be administered intravenously (IV) at 2000 milligram (mg) bi-weekly in 28 day Cycle.
Administreras IV

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Progression Free Survival (PFS) Rate
Tidsram: 8 Weeks
8 Weeks

Sekundära resultatmått

Resultatmått
Tidsram
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)
Baseline to Confirmed CR or PR (Estimated up to 4 Months)
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)
Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
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)
Date of CR or PR to Date of Measured Recurrent or Progressive Disease or Death from Any Cause (Estimated up to 4 Months)
Overall Survival (OS)
Tidsram: Baseline to Death from Any Cause (Estimated up to 6 Months)
Baseline to Death from Any Cause (Estimated up to 6 Months)
Pharmacokinetics (PK): Systemic Clearance (CL) of LY287358
Tidsram: Baseline to Study Completion (Estimated up to 4 Months)
Baseline to Study Completion (Estimated up to 4 Months)
Pharmacokinetics (PK): Volume of distribution (V) of LY287358
Tidsram: Baseline to Study Completion (Estimated up to 4 Months)
Baseline to Study Completion (Estimated up to 4 Months)
PFS
Tidsram: Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 6 Months)
Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 6 Months)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

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

Andra studie-ID-nummer

  • 15007
  • I4C-JE-JTBE (Annan identifierare: Eli Lilly and Company)

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