Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
28. marts 2014 opdateret af: Amgen
A Phase 1b/2 Study of AMG 655 in Combination With Modified FOLFOX6 and Bevacizumab for the First-Line Treatment of Subjects With Metastatic Colorectal Cancer
This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic colorectal cancer (CRC).
The clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be measured by progression-free survival, objective response rate, time to response, duration of response, and overall survival. This study is also designed to evaluate the safety and tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate anti-AMG 655 antibody formation and the pharmacokinetics of AMG 655.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
202
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arkansas
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Hot Springs, Arkansas, Forenede Stater, 71913
- Research Site
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California
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Downey, California, Forenede Stater, 90241
- Research Site
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La Jolla, California, Forenede Stater, 92093-0957
- Research Site
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Loma Linda, California, Forenede Stater, 92354
- Research Site
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Orange, California, Forenede Stater, 92868
- Research Site
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Rancho Mirage, California, Forenede Stater, 92270
- Research Site
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San Diego, California, Forenede Stater, 92123
- Research Site
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Colorado
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Denver, Colorado, Forenede Stater, 80218
- Research Site
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Delaware
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Newark, Delaware, Forenede Stater, 19718
- Research Site
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20007
- Research Site
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Florida
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Boca Raton, Florida, Forenede Stater, 33486
- Research Site
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Kissimmee, Florida, Forenede Stater, 34741
- Research Site
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Leesburg, Florida, Forenede Stater, 34788
- Research Site
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Miami, Florida, Forenede Stater, 33176
- Research Site
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Miami, Florida, Forenede Stater, 33136
- Research Site
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Georgia
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Atlanta, Georgia, Forenede Stater, 30309
- Research Site
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Lawrenceville, Georgia, Forenede Stater, 30045
- Research Site
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Illinois
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Harvey, Illinois, Forenede Stater, 60426
- Research Site
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Maywood, Illinois, Forenede Stater, 60153
- Research Site
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46227
- Research Site
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Kansas
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Overland Park, Kansas, Forenede Stater, 66210
- Research Site
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
- Research Site
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Maryland
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Baltimore, Maryland, Forenede Stater, 21237
- Research Site
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Baltimore, Maryland, Forenede Stater, 21215
- Research Site
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Research Site
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48106-0995
- Research Site
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St. Joseph, Michigan, Forenede Stater, 49085
- Research Site
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Research Site
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Missouri
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St. Louis, Missouri, Forenede Stater, 63136
- Research Site
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Montana
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Great Falls, Montana, Forenede Stater, 59405
- Research Site
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New Jersey
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Long Branch, New Jersey, Forenede Stater, 07740
- Research Site
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87109-4397
- Research Site
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New York
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Bronx, New York, Forenede Stater, 10469
- Research Site
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Buffalo, New York, Forenede Stater, 14263
- Research Site
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Hudson, New York, Forenede Stater, 12534
- Research Site
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New York, New York, Forenede Stater, 10021
- Research Site
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
- Research Site
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Burlington, North Carolina, Forenede Stater, 27215
- Research Site
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Gastonia, North Carolina, Forenede Stater, 28054
- Research Site
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Raleigh, North Carolina, Forenede Stater, 27607
- Research Site
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Winston Salem, North Carolina, Forenede Stater, 27103
- Research Site
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45226
- Research Site
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Columbus, Ohio, Forenede Stater, 43219
- Research Site
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Middletown, Ohio, Forenede Stater, 45042
- Research Site
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Oregon
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Portland, Oregon, Forenede Stater, 97227
- Research Site
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Pennsylvania
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Harrisburg, Pennsylvania, Forenede Stater, 17109
- Research Site
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Research Site
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Pottsville, Pennsylvania, Forenede Stater, 17901
- Research Site
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29605
- Research Site
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38120
- Research Site
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Nashville, Tennessee, Forenede Stater, 37203
- Research Site
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Texas
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Austin, Texas, Forenede Stater, 78731
- Research Site
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Richardson, Texas, Forenede Stater, 75080
- Research Site
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Tyler, Texas, Forenede Stater, 75702
- Research Site
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Wichita Falls, Texas, Forenede Stater, 76310
- Research Site
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Utah
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Ogden, Utah, Forenede Stater, 84403
- Research Site
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Virginia
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Fairfax, Virginia, Forenede Stater, 22031
- Research Site
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Norfolk, Virginia, Forenede Stater, 23502
- Research Site
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Richmond, Virginia, Forenede Stater, 23235
- Research Site
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Washington
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Tacoma, Washington, Forenede Stater, 98405
- Research Site
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Vancouver, Washington, Forenede Stater, 98684
- Research Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
- Subjects with measurable or unmeasurable disease
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Men or women at least 18 years of age
- Adequate hematologic, renal, hepatic and coagulation function
Exclusion Criteria:
- History or known presence of central nervous system (CNS) metastases
- Prior chemotherapy or other systemic therapy for advanced or metastatic CRC
- Any investigational agent or therapy for advanced or metastatic CRC
- Clinically significant cardiac disease
- Clinically significant peripheral neuropathy
- Active inflammatory bowel disease
- Recent gastrointestinal ulcer or hemorrhage
- Recent arterial thrombotic event or pulmonary embolus
- Recent history of clinically significant bleeding, bleeding diathesis, or coagulopathy
- Recent major surgical procedure or not yet recovered from major surgery
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: AMG 655 Low Dose
AMG 655 (low dose) + mFOLFOX6 + Bevacizumab
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AMG 655 er et forsøgsmæssigt, fuldt humant monoklonalt agonist-antistof, der selektivt binder til Death Receptor-5 (DR5).
Combination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)] administered by intravenous infusion once every 14 days (+3 days)
Andre navne:
Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).
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Placebo komparator: Placebo
Placebo + mFOLFOX6 + Bevacizumab
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Combination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)] administered by intravenous infusion once every 14 days (+3 days)
Andre navne:
Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).
Inactive dummy AMG 655 (to maintain blind)
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Eksperimentel: AMG 655 High Dose
AMG 655 (high dose) + mFOLFOX6 + Bevacizumab
|
AMG 655 er et forsøgsmæssigt, fuldt humant monoklonalt agonist-antistof, der selektivt binder til Death Receptor-5 (DR5).
Combination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)] administered by intravenous infusion once every 14 days (+3 days)
Andre navne:
Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Progressionsfri overlevelse
Tidsramme: Studielængde
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Studielængde
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Overall survival
Tidsramme: Length of study
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Length of study
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Objective response rate
Tidsramme: Length of study
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Length of study
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Duration of response
Tidsramme: Length of study
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Length of study
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Time-to-response
Tidsramme: Length of study
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Length of study
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AMG 655 pharmacokinetic parameters
Tidsramme: Length of study
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Length of study
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The incidence of anti-AMG 655 antibody formation
Tidsramme: Length of study
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Length of study
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2007
Primær færdiggørelse (Faktiske)
1. august 2010
Studieafslutning (Faktiske)
1. september 2011
Datoer for studieregistrering
Først indsendt
14. februar 2008
Først indsendt, der opfyldte QC-kriterier
20. februar 2008
Først opslået (Skøn)
28. februar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
25. april 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. marts 2014
Sidst verificeret
1. marts 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kolorektale neoplasmer
- Rektale neoplasmer
- Colon neoplasmer
- Lægemidlers fysiologiske virkninger
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Bevacizumab
- Conatumumab
Andre undersøgelses-id-numre
- 20060464
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .