Phase 2 Study of AMG 386 Plus Paclitaxel With or Without Bevacizumab as First Line Therapy in Her2-Negative Breast Cancer Patients

Part of paid clinical trials in Litchfield Park, Arizona.

Sponsor
Amgen
Study ID
NCT00511459
Phase
PHASE2
Status
Completed

Conditions

  • Locally Recurrent and Metastatic Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • AMG 386 Placebo — DRUG
    AMG 386 Placebo \[blinded\]
  • AMG 386 — DRUG
    AMG 386 3mg/kg IV QW \[blinded\]
  • Bevacizumab — DRUG
    Bevacizumab 10mg/kg IV Q2W
  • AMG 386 — DRUG
    AMG 386 10mg/kg IV QW \[Open-Label\]
  • AMG 386 — DRUG
    AMG 386 10mg/kg IV QW \[blinded\]
  • Paclitaxel — DRUG
    Paclitaxel 90mg/m2 IV QW (3 on/1 0ff)

Study Details

This is a phase 2, randomized, placebo controlled, multi-center study to estimate the treatment effect and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel and paclitaxel/bevacizumab in the treatment of subjects with Her2-negative metastatic or locally recurrent breast cancer. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

Key Dates

First listed
Aug 3, 2007
Start date
Jul 31, 2007
Status verified
Oct 2015
Primary completion
Aug 31, 2010
Completion
May 31, 2014

Study Design

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

Arms

  • Experimental: A
    Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 10 mg/kg IV QW
  • Experimental: D
    Paclitaxel 90 mg/m² IV QW (3 on/1 off) + Open Label AMG 386 10 mg/kg IV QW
  • Experimental: B
    Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 3 mg/kg IV QW
  • Active Comparator: C
    Paclitaxel 90 mg/m² IV QW (3 on/1 off) + bevacizumab 10 mg/kg IV Q2W + AMG 386 placebo IV QW

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: 3 YEARS ]

Locations (26)

FacilityCityStateZIPSite coordinators
Research SiteLitchfield ParkArizona85340-
Research SiteTucsonArizona85724-
Research SiteHot SpringsArkansas71913-
Research SiteLittle RockArkansas72205-
Research SiteCampbellCalifornia95008-
Research SiteLos AngelesCalifornia90095-
Research SiteMurrietaCalifornia92562-
Research SiteSanta MariaCalifornia93454-
Research SiteNew HavenConnecticut06520-
Research SiteStamfordConnecticut06902-
Research SiteOrlandoFlorida32804-
Research SiteRobbinsdaleMinnesota55422-
Research SiteHendersonNevada89052-
Research SiteLebanonNew Hampshire03756-
Research SiteNashuaNew Hampshire03061-
Research SiteEdisonNew Jersey08820-
Research SiteMountain LakesNew Jersey07046-
Research SiteAshevilleNorth Carolina28806-
Research SiteCharlotteNorth Carolina28203-
Research SiteHersheyPennsylvania17033-
Research SitePhiladelphiaPennsylvania19106-
Research SiteColumbiaSouth Carolina29210-
Research SiteRichardsonTexas75080-
Research SiteSan AntonioTexas78229-
Research SiteSugar LandTexas77479-
Research SiteOgdenUtah84403-

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