Safety Study of AMG 386 to Treat HER2-positive Locally Recurrent or Metastatic Breast Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Amgen
Study ID
NCT00807859
Phase
PHASE1
Status
Completed

Conditions

  • Breast Cancer
  • Breast Neoplasms
  • Breast Tumors
  • Cancer
  • Locally Recurrent and Metastatic Breast Cancer
  • Metastases
  • Metastatic Cancer
  • Oncology
  • Solid Tumors
  • Tumors

Eligibility Criteria

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

Interventions

  • AMG 386 30 mg/kg, Paclitaxel and Trastuzumab — DRUG
    AMG 386 30 mg/kg IV QW, paclitaxel 80 mg/m2 IV QW, trastuzumab: initial dose 8 mg/kg IV week 1, then 6 mg/kg IV Q3W
  • AMG 386 30 mg/kg, Capecitabine and Lapatinib — DRUG
    AMG 386 30 mg/kg IV QW, capecitabine 2000 mg/m2 divided into 2 doses given PO Q12 hrs, days 1-14 every 21 days, lapatinib 1250 mg PO QD
  • AMG 386 10 mgkg, Paclitaxel and Trastuzumab — DRUG
    AMG 386 10 mg/kg IV QW, paclitaxel 80 mg/m2 IV QW, trastuzumab: initial dose 8 mg/kg IV week 1, then 6 mg/kg IV Q3W
  • AMG 386 10 mg/kg, Capecitabine and Lapatinib — DRUG
    AMG 386 10 mg/kg IV QW, capecitabine 2000 mg/m2 divided into 2 doses given PO Q12 hrs, days 1-14 every 21 days, lapatinib 1250 mg PO QD

Study Details

The purpose of this study is to determine if AMG 386 in combination with either paclitaxel and trastuzumab or capecitabine and lapatinib is safe and well tolerated in subjects with HER2-positive locally recurrent or metastatic breast cancer. This is an open-label phase 1b trial and has 2 study parts. Study part 1 is a dose escalation study to determine a tolerable dose of AMG 386 in combination with paclitaxel and trastuzumab (cohort A) or with capecitabine and lapatinib (cohort B). Study part 2 is cohort expansion of the tolerable doses determined in part 1.

Key Dates

Start date
Mar 9, 2009
Status verified
Nov 2022
Primary completion
Feb 27, 2014
Completion
Oct 19, 2015

Study Design

Enrollment
65 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A1
  • Experimental: Cohort A3
  • Experimental: Cohort B1
  • Experimental: Cohort B3

Primary Outcome Measure

Primary objective is to identify the incidence of adverse events and clinical laboratory abnormalities defined as a dose limiting toxicity in subjects treated with AMG 386 plus paclitaxel and trastuzumab or with AMG 386 plus capecitabine and lapatinib [ Time Frame: 24 months ]

Locations (13)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85724-
Research SiteBoca RatonFlorida33428-
Research SiteIowa CityIowa52242-
Research SiteBostonMassachusetts02111-
Research SiteMinneapolisMinnesota55407-
Research SiteLebanonNew Hampshire03756-0001-
Research SiteLebanonNew Hampshire03756-
Research SiteAlbuquerqueNew Mexico87131-
Research SiteGreat NeckNew York11021-
Research SiteNew CityNew York10956-
Research SiteNew YorkNew York10032-
Research SiteNyackNew York10960-
Research SiteMiddletownOhio45042-

Find similar trials in Tucson, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Research Site· Tucson, AZResearch Site· Boca Raton, FLResearch Site· Iowa City, IAResearch Site· Boston, MAResearch Site· Minneapolis, MNResearch Site· Lebanon, NH

Related Studies