Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer

Part of paid clinical trials in Hot Springs, Arkansas.

Sponsor
Amgen
Study ID
NCT00625651
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Inactive dummy AMG 655 (to maintain blind)
  • AMG 655 — DRUG
    AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
  • Modified FOLFOX6 — DRUG
    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)
  • Bevacizumab — DRUG
    Bevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).

Study Details

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.

Key Dates

First listed
Feb 28, 2008
Start date
Oct 31, 2007
Status verified
Mar 2014
Primary completion
Aug 31, 2010
Completion
Sep 30, 2011

Study Design

Enrollment
202 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AMG 655 Low Dose
    AMG 655 (low dose) + mFOLFOX6 + Bevacizumab
  • Placebo Comparator: Placebo
    Placebo + mFOLFOX6 + Bevacizumab
  • Experimental: AMG 655 High Dose
    AMG 655 (high dose) + mFOLFOX6 + Bevacizumab

Primary Outcome Measure

Progression-free survival [ Time Frame: Length of study ]

Locations (61)

FacilityCityStateZIPSite coordinators
Research SiteHot SpringsArkansas71913-
Research SiteDowneyCalifornia90241-
Research SiteLa JollaCalifornia92093-0957-
Research SiteLoma LindaCalifornia92354-
Research SiteOrangeCalifornia92868-
Research SiteRancho MirageCalifornia92270-
Research SiteSan DiegoCalifornia92123-
Research SiteDenverColorado80218-
Research SiteNewarkDelaware19718-
Research SiteWashington D.C.District of Columbia20007-
Research SiteBoca RatonFlorida33486-
Research SiteKissimmeeFlorida34741-
Research SiteLeesburgFlorida34788-
Research SiteMiamiFlorida33136-
Research SiteMiamiFlorida33176-
Research SiteAtlantaGeorgia30309-
Research SiteLawrencevilleGeorgia30045-
Research SiteHarveyIllinois60426-
Research SiteMaywoodIllinois60153-
Research SiteIndianapolisIndiana46227-
Research SiteOverland ParkKansas66210-
Research SiteLouisvilleKentucky40202-
Research SiteBaltimoreMaryland21215-
Research SiteBaltimoreMaryland21237-
Research SiteBostonMassachusetts02115-
Research SiteAnn ArborMichigan48106-0995-
Research SiteSaint JosephMichigan49085-
Research SiteRochesterMinnesota55905-
Research SiteSt LouisMissouri63136-
Research SiteGreat FallsMontana59405-
Research SiteLong BranchNew Jersey07740-
Research SiteAlbuquerqueNew Mexico87109-4397-
Research SiteBuffaloNew York14263-
Research SiteHudsonNew York12534-
Research SiteNew YorkNew York10021-
Research SiteThe BronxNew York10469-
Research SiteAshevilleNorth Carolina28801-
Research SiteBurlingtonNorth Carolina27215-
Research SiteGastoniaNorth Carolina28054-
Research SiteRaleighNorth Carolina27607-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteCincinnatiOhio45226-
Research SiteColumbusOhio43219-
Research SiteMiddletownOhio45042-
Research SitePortlandOregon97227-
Research SiteHarrisburgPennsylvania17109-
Research SitePhiladelphiaPennsylvania19107-
Research SitePottsvillePennsylvania17901-
Research SiteGreenvilleSouth Carolina29605-
Research SiteMemphisTennessee38120-
Research SiteNashvilleTennessee37203-
Research SiteAustinTexas78731-
Research SiteRichardsonTexas75080-
Research SiteTylerTexas75702-
Research SiteWichita FallsTexas76310-
Research SiteOgdenUtah84403-
Research SiteFairfaxVirginia22031-
Research SiteNorfolkVirginia23502-
Research SiteRichmondVirginia23235-
Research SiteTacomaWashington98405-
Research SiteVancouverWashington98684-

Find similar trials in Hot Springs, AR

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Research Site· Hot Springs, ARResearch Site· Downey, CAResearch Site· La Jolla, CAResearch Site· Loma Linda, CAResearch Site· Orange, CAResearch Site· Rancho Mirage, CA

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