ensemble ami

ensemble ami

Sponsorer

Hovedsponsor: Amgen

Kilde Amgen
Kort resumé

ensemble ami

Samlet status Rekruttering
Start dato 2018-08-27
Afslutningsdato 2025-02-24
Primær afslutningsdato 2025-02-24
Fase Fase 1 / fase 2
Undersøgelsestype Interventionel
Primært resultat
Måle Tidsramme
Primary: Number of subjects with treatment-emergent adverse events 24 Months
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami Baseline til 24 måneder
ensemble ami Baseline til 24 måneder
ensemble ami Baseline til 24 måneder
ensemble ami Baseline til 24 måneder
ensemble ami 21 dage
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
Sekundært resultat
Måle Tidsramme
Secondary: Plasma concentration (Cmax) of AMG 510 24 Months
ensemble ami 16 dage
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 16 dage
ensemble ami 16 dage
ensemble ami 16 dage
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami Baseline til 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 6 måneder
ensemble ami 12 måneder
ensemble ami 12 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami 24 måneder
ensemble ami Baseline til 24 måneder
Tilmelding 733
Tilstand
Intervention

Interventionstype: Drug

Interventionens navn: AMG 510

Beskrivelse: Characterize the pharmacokinetics (PK) of AMG 510 following administration as an oral Tablet formulation

Interventionstype: Medicin

Interventionens navn: ensemble ami

Beskrivelse: ensemble ami

Arm Group-etiket: ensemble ami

Interventionstype: Medicin

Interventionens navn: Midazolam

Beskrivelse: ensemble ami

Arm Group-etiket: ensemble ami

Støtteberettigelse

Kriterier:

ensemble ami

Køn:

Alle

Minimumsalder:

18 år

Maksimal alder:

100 år

Sunde frivillige:

절차 (비 복강경 수술 흉부, 심장, 복부 또는 혈관 수술) 동안, 대상은 1 차 표준의 기존 수술 지혈 방법이 효과가 있고 비실용적 인 더 많은 후 대상 부위 출혈에 경증에서 중도의 연조직, 혈관 실질이 있습니다. . 사용 지침에 따라 Surgicel을 적용해야합니다.

Samlet officiel
Efternavn Rolle tilknytning
MD Study Director Amgen
Samlet kontakt

Efternavn: Amgen Call Center

telefon: 866-572-6436

E-mail: [email protected]

Beliggenhed
Anlæg: Status:
City of Hope National Medical Center | Duarte, California, 91010, United States Recruiting
University of California Los Angeles | Los Angeles, California, 90095, United States Recruiting
University of California at SF | San Francisco, California, 94115, United States Recruiting
Sarcoma Oncology Research Center LLC | Santa Monica, California, 90403, United States Recruiting
Rocky Mountain Cancer Centers | Denver, Colorado, 80218, United States Recruiting
Sarah Cannon Research Institute at HealthONE | Denver, Colorado, 80218, United States Recruiting
Smilow Cancer Hospital at Yale New Haven | New Haven, Connecticut, 06510, United States Recruiting
Medical Oncology Hematology Consultants Helen F Graham Cancer Center | Newark, Delaware, 19713, United States Recruiting
University of Florida Health | Gainesville, Florida, 32610, United States Recruiting
AdventHealth Orlando Infusion Center | Orlando, Florida, 32804, United States Recruiting
Moffitt Cancer Center | Tampa, Florida, 33612, United States Recruiting
Winship Cancer Institute | Atlanta, Georgia, 30322, United States Recruiting
Indiana University | Indianapolis, Indiana, 46202, United States Recruiting
American Oncology Partners of Maryland, PA | Bethesda, Maryland, 20817, United States Recruiting
Massachusetts General Hospital | Boston, Massachusetts, 02114, United States Recruiting
Dana Farber Cancer Institute | Boston, Massachusetts, 02215, United States Recruiting
University of Michigan | Ann Arbor, Michigan, 48109, United States Recruiting
Henry Ford Health System | Detroit, Michigan, 48202, United States Recruiting
Washington University | Saint Louis, Missouri, 63110-1093, United States Recruiting
Roswell Park Cancer Institute | Buffalo, New York, 14263, United States Recruiting
Laura and Isaac Perlmutter Cancer Center at New York University Langone | New York, New York, 10016, United States Recruiting
Memorial Sloan Kettering Cancer Center | New York, New York, 10065, United States Recruiting
Duke University Medical Center, Morris Cancer Clinic | Durham, North Carolina, 27710, United States Recruiting
University Hospitals Cleveland Medical Center | Cleveland, Ohio, 44106, United States Recruiting
Cleveland Clinic | Cleveland, Ohio, 44195, United States Recruiting
University of Pennsylvania | Philadelphia, Pennsylvania, 19104, United States Recruiting
Fox Chase Cancer Center | Philadelphia, Pennsylvania, 19111, United States Recruiting
University of Pittsburgh Medical Center Cancer Pavillion | Pittsburgh, Pennsylvania, 15232, United States Recruiting
Gibbs Cancer Center and Research Institute - Spartanburg | Spartanburg, South Carolina, 29303, United States Recruiting
Vanderbilt University Ingram Cancer Center | Nashville, Tennessee, 37232, United States Recruiting
Texas Oncology Austin Central | Austin, Texas, 78731, United States Recruiting
Baylor Charles A Sammons Cancer Center | Dallas, Texas, 75246, United States Recruiting
University of Texas Southwestern Medical Center | Dallas, Texas, 75390, United States Recruiting
University of Texas MD Anderson Cancer Center | Houston, Texas, 77030, United States Recruiting
Huntsman Cancer Institute | Salt Lake City, Utah, 84112, United States Recruiting
US Oncology Research Investigational Products Center | Fairfax, Virginia, 22031, United States Recruiting
Virginia Cancer Specialists PC | Fairfax, Virginia, 22031, United States Recruiting
Blue Ridge Cancer Care | Salem, Virginia, 24153, United States Recruiting
Seattle Cancer Care Alliance | Seattle, Washington, 98109, United States Recruiting
Scientia Clinical Research Ltd | Randwick, New South Wales, 2031, Australia Recruiting
Princess Alexandra Hospital | Woolloongabba, Queensland, 4102, Australia Recruiting
The Queen Elizabeth Hospital | Woodville South, South Australia, 5011, Australia Recruiting
Peter MacCallum Cancer Centre | Parkville, Victoria, 3050, Australia Recruiting
Medizinische Universitaet Graz | Graz, 8036, Austria Recruiting
Medizinische Universitaet Innsbruck | Innsbruck, 6020, Austria Recruiting
Universitaetsklinikum Krems | Krems, 3500, Austria Recruiting
Universitaetsklinikum Allgemeines Krankenhaus Wien | Wien, 1090, Austria Recruiting
Institut Jules Bordet | Bruxelles, 1000, Belgium Recruiting
Universitair Ziekenhuis Antwerpen | Edegem, 2650, Belgium Recruiting
Universitair Ziekenhuis Gent | Gent, 9000, Belgium Recruiting
Universitair Ziekenhuis Leuven - Campus Gasthuisberg | Leuven, 3000, Belgium Recruiting
Irmandade da Santa Casa de Misericordia de Porto Alegre, Nucleo de Novos Tratamentos em Cancer | Porto Alegre, Rio Grande Do Sul, 90050-170, Brazil Recruiting
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul | Porto Alegre, Rio Grande Do Sul, 90610-000, Brazil Recruiting
Sociedade Beneficente de Senhoras Hospital Sirio Libanes | Sao Paulo, São Paulo, 01308-050, Brazil Recruiting
Oncologia Rede D´Or | Sao Paulo, São Paulo, 04501-000, Brazil Recruiting
Hospital de Base de Sao Jose do Rio Preto | São José do Rio Preto, São Paulo, 15090-000, Brazil Recruiting
Instituto Coi | Rio de Janeiro, 22793-080, Brazil Recruiting
Tom Baker Cancer Centre | Calgary, Alberta, T2N 4N2, Canada Recruiting
Cross Cancer Institute | Edmonton, Alberta, T6G 1Z2, Canada Recruiting
London Regional Cancer Program, London Health Sciences Centre | London, Ontario, N6A 5W9, Canada Recruiting
The Ottawa Hospital Cancer Centre | Ottawa, Ontario, K1H 8L6, Canada Recruiting
Princess Margaret Cancer Centre | Toronto, Ontario, M5G 2M9, Canada Recruiting
Institut Bergonie | Bordeaux, 33076, France Recruiting
Centre Hospitalier Intercommunal de Créteil | Créteil, 94010, France Recruiting
Hopital de la Timone | Marseille cedex 5, 13385, France Recruiting
Institut Curie | Paris, 75005, France Recruiting
Institut Claudius Regaud | Toulouse cedex 9, 31059, France Recruiting
Gustave Roussy | Villejuif, 94805, France Recruiting
Universitätsklinikum Essen | Essen, 45147, Germany Recruiting
Universitatsklinikum Koln | Köln, 50937, Germany Recruiting
Klinikum der Universität München Campus Großhadern | München, 81377, Germany Recruiting
Aichi Cancer Center Hospital | Nagoya-shi, Aichi, 464-8681, Japan Recruiting
National Cancer Center Hospital East | Kashiwa-shi, Chiba, 277-8577, Japan Recruiting
National Hospital Organization Shikoku Cancer Center | Matsuyama-shi, Ehime, 791-0280, Japan Recruiting
National Hospital Organization Kyushu Cancer Center | Fukuoka-shi, Fukuoka, 811-1395, Japan Recruiting
St Marianna University School of Medicine Hospital | Kawasaki-shi, Kanagawa, 216-8511, Japan Recruiting
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center | Yokohama-shi, Kanagawa, 241-8515, Japan Recruiting
Sendai Kousei Hospital | Sendai-shi, Miyagi, 980-0873, Japan Recruiting
Kansai Medical University Hospital | Hirakata-shi, Osaka, 573-1191, Japan Recruiting
Osaka International Cancer Institute | Osaka-shi, Osaka, 541-8567, Japan Recruiting
Shizuoka Cancer Center | Sunto-gun, Shizuoka, 411-8777, Japan Recruiting
Cancer Institute Hospital of Japanese Foundation for Cancer Research | Koto-ku, Tokyo, 135-8550, Japan Recruiting
Wakayama Medical University Hospital | Wakayama-shi, Wakayama, 641-8510, Japan Recruiting
Seoul National University Hospital | Seoul, 03080, Korea, Republic of Recruiting
Severance Hospital Yonsei University Health System | Seoul, 03722, Korea, Republic of Recruiting
Asan Medical Center | Seoul, 05505, Korea, Republic of Recruiting
Samsung Medical Center | Seoul, 06351, Korea, Republic of Recruiting
The Catholic University of Korea Seoul St Marys Hospital | Seoul, 06591, Korea, Republic of Recruiting
Universitaetsspital Basel | Basel, 4031, Switzerland Recruiting
Hopitaux Universitaires de Geneve | Geneve, 1211, Switzerland Recruiting
Universitaetsspital Zuerich | Zurich, 8091, Switzerland Recruiting
Placeringslande

Australia

Austria

Belgium

Brazil

Canada

France

Germany

Japan

Korea, Republic of

Switzerland

United States

Verifikationsdato

2021-06-01

Ansvarlig part

Type: 절차 (비 복강경 수술 흉부, 심장, 복부 또는 혈관 수술) 동안, 대상은 1 차 표준의 기존 수술 지혈 방법이 효과가 있고 비실용적 인 더 많은 후 대상 부위 출혈에 경증에서 중도의 연조직, 혈관 실질이 있습니다. . 사용 지침에 따라 Surgicel을 적용해야합니다.

Har udvidet adgang Ja
Antal våben 6
Arm Group

Etiket: Phase 1 Dose Exploration Part 1 monotherapy

Type: Experimental

Beskrivelse: Cohorts with food effect and alternative dosing regimens Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 2-4 subjects treated at the lowest planned dose level of 180 mg. If no DLT is observed, dose escalation will continue to the next planned dose cohort

Etiket: ensemble ami

Type: 절차 (비 복강경 수술 흉부, 심장, 복부 또는 혈관 수술) 동안, 대상은 1 차 표준의 기존 수술 지혈 방법이 효과가 있고 비실용적 인 더 많은 후 대상 부위 출혈에 경증에서 중도의 연조직, 혈관 실질이 있습니다. . 사용 지침에 따라 Surgicel을 적용해야합니다.

Beskrivelse: ensemble ami

Etiket: ensemble ami

Type: 절차 (비 복강경 수술 흉부, 심장, 복부 또는 혈관 수술) 동안, 대상은 1 차 표준의 기존 수술 지혈 방법이 효과가 있고 비실용적 인 더 많은 후 대상 부위 출혈에 경증에서 중도의 연조직, 혈관 실질이 있습니다. . 사용 지침에 따라 Surgicel을 적용해야합니다.

Beskrivelse: ensemble ami

Etiket: ensemble ami

Type: 절차 (비 복강경 수술 흉부, 심장, 복부 또는 혈관 수술) 동안, 대상은 1 차 표준의 기존 수술 지혈 방법이 효과가 있고 비실용적 인 더 많은 후 대상 부위 출혈에 경증에서 중도의 연조직, 혈관 실질이 있습니다. . 사용 지침에 따라 Surgicel을 적용해야합니다.

Beskrivelse: ensemble ami

Etiket: ensemble ami

Type: 절차 (비 복강경 수술 흉부, 심장, 복부 또는 혈관 수술) 동안, 대상은 1 차 표준의 기존 수술 지혈 방법이 효과가 있고 비실용적 인 더 많은 후 대상 부위 출혈에 경증에서 중도의 연조직, 혈관 실질이 있습니다. . 사용 지침에 따라 Surgicel을 적용해야합니다.

Beskrivelse: ensemble ami

Etiket: ensemble ami

Type: 절차 (비 복강경 수술 흉부, 심장, 복부 또는 혈관 수술) 동안, 대상은 1 차 표준의 기존 수술 지혈 방법이 효과가 있고 비실용적 인 더 많은 후 대상 부위 출혈에 경증에서 중도의 연조직, 혈관 실질이 있습니다. . 사용 지침에 따라 Surgicel을 적용해야합니다.

Beskrivelse: ensemble ami

Info om studiedesign

Tildeling: Tilfældigt

Interventionsmodel: Sekventiel tildeling

Primært formål: Behandling

Maskering: Ingen (åben etiket)

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