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

NCT ID: NCT00788333

Last Updated: 2012-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Advanced or Metastatic Her-2-positive Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Combination

Group Type EXPERIMENTAL

BMS-754807

Intervention Type DRUG

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

trastuzumab (Herceptin®)

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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IGF-IR Herceptin®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Kurralta Park, South Australia, Australia

Site Status

Local Institution

Frankston, Victoria, Australia

Site Status

Local Institution

Geelong, Victoria, Australia

Site Status

Local Institution

Brussels, , Belgium

Site Status

Local Institution

Ottawa, Ontario, Canada

Site Status

Local Institution

Toronto, Ontario, Canada

Site Status

Local Institution

Budapest, , Hungary

Site Status

Local Institution

Miskolc, , Hungary

Site Status

Local Institution

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

Countries

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Netherlands Australia Belgium Canada Hungary United Kingdom

Related Links

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http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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EUDRACT #: 2009-013766-78

Identifier Type: -

Identifier Source: secondary_id

CA191-004

Identifier Type: -

Identifier Source: org_study_id