NCT00788333

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Jul 2009

Geographic Reach
5 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 10, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

2.3 years

First QC Date

November 7, 2008

Last Update Submit

July 12, 2012

Conditions

Breast Cancer

Keywords

Advanced or Metastatic Her-2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    Every 30 days until MTD is reached

Secondary Outcomes (5)

  • Assess anti-tumor activity of combination at MTD of BMS-754807 (dose expansion cohort)

    Every 8 weeks

  • Evaluate safety and tolerability of the combination regimen

    Ongoing

  • Assess effect of combination therapy on glucose metabolism

    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

    Ongoing

  • Obtain BMS-754807 plasma concentrations vs time data for future population PK analysis

    Days, 1,8,15,22

Study Arms (1)

A

EXPERIMENTAL

Combination

Drug: BMS-754807Drug: trastuzumab (Herceptin®)

Interventions

BMS-754807DRUG

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

Also known as: IGF-IR
A
trastuzumab (Herceptin®)DRUG

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

Also known as: Herceptin®
A

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Local Institution

Kurralta Park, South Australia, 5037, Australia

Location

Local Institution

Frankston, Victoria, 3199, Australia

Location

Local Institution

Geelong, Victoria, 3220, Australia

Location

Local Institution

Brussels, 1000, Belgium

Location

Local Institution

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution

Toronto, Ontario, M5G 1X5, Canada

Location

Local Institution

Budapest, 1122, Hungary

Location

Local Institution

Miskolc, 3526, Hungary

Location

Local Institution

Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BMS 754807Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2008

First Posted

November 10, 2008

Study Start

July 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

July 13, 2012

Record last verified: 2012-07

Locations

BE(1)HU(2)CA(2)GB(1)AU(3)