Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer

July 12, 2012 updated by: Bristol-Myers Squibb

A Phase I/II Trial of BMS-754807 in Combination With Trastuzumab (Herceptin®) in Subjects With Advanced or Metastatic Her-2-positive Breast Cancer

This is a Phase I/II study to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics following daily oral doses of 50 to 200 mg of BMS-754807 in combination with trastuzumab (Herceptin®) in subjects with advanced or metastatic Her-2-positive breast cancer. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 in combination with trastuzumab for Phase II studies and provide preliminary evidence of anti-tumor activity in Her-2-positive breast cancer subjects after trastuzumab failure

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Local Institution
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Local Institution
      • Geelong, Victoria, Australia, 3220
        • Local Institution
  • Belgium
      • Brussels, Belgium, 1000
        • Local Institution
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution
      • Toronto, Ontario, Canada, M5G 1X5
        • Local Institution
  • Hungary
      • Budapest, Hungary, 1122
        • Local Institution
      • Miskolc, Hungary, 3526
        • Local Institution
  • United Kingdom
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

For additional information on this trial, please call (910) 558-2913

Inclusion Criteria:

  • Subjects with locally advanced or metastatic Her-2-positive breast cancer who have failed at least one trastuzumab containing regimen. Prior treatment with other Her-2-targeted agents (e.g. lapatinib, pertuzumab, trastuzumab DM-1 etc.) is allowed
  • Histologic or cytologic diagnosis of Her-2-positive breast cancer
  • ECOG status 0 - 1

Exclusion Criteria:

  • Symptomatic brain metastasis
  • Any condition requiring chronic use of steroids
  • Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms
  • History of glucose intolerance
  • Women of child-bearing potential unwilling or unable to use acceptable contraception methods

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Combination
Drug: BMS-754807
Tablets, Oral, Dose escalation to MTD, then MTD to response/EOT, once daily, Varies - treatment is continued to disease progression or MD/subject/Sponsor decision to stop
Other Names:
  • IGF-IR
Drug: trastuzumab (Herceptin®)
IV solution, IV, 4mg/kg Day 1 loading dose, 2mg/kg once weekly, Varies - treatment is continued to disease progression or MD/subject/Sponsor decision to stop
Other Names:
  • Herceptin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The dose escalation portion will determine the MTD and recommended Phase 2 dose or dose range of BMS-754807 when administered orally on a daily schedule in combination with trastuzumab administered at standard doses IV on a weekly basis
Time Frame: Every 30 days until MTD is reached
Every 30 days until MTD is reached

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess anti-tumor activity of combination at MTD of BMS-754807 (dose expansion cohort)
Time Frame: Every 8 weeks
Every 8 weeks
Evaluate safety and tolerability of the combination regimen
Time Frame: Ongoing
Ongoing
Assess effect of combination therapy on glucose metabolism
Time Frame: At 30 days, then every 8 weeks
At 30 days, then every 8 weeks
Explore whether co-medication with oral anti-hyperglycemic agent can enable adequate tolerability of the combination therapy if BMS-754807 induces hyperglycemia
Time Frame: Ongoing
Ongoing
Obtain BMS-754807 plasma concentrations vs time data for future population PK analysis
Time Frame: Days, 1,8,15,22
Days, 1,8,15,22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

November 7, 2008

First Posted (ESTIMATE)

November 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 13, 2012

Last Update Submitted That Met QC Criteria

July 12, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA191-004
  • EUDRACT #: 2009-013766-78

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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