- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00788333
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
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South Australia
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Kurralta Park, South Australia, Australia, 5037
- Local Institution
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Victoria
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Frankston, Victoria, Australia, 3199
- Local Institution
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Geelong, Victoria, Australia, 3220
- Local Institution
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Brussels, Belgium, 1000
- Local Institution
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- Local Institution
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Toronto, Ontario, Canada, M5G 1X5
- Local Institution
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Budapest, Hungary, 1122
- Local Institution
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Miskolc, Hungary, 3526
- Local Institution
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Tyne And Wear
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Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
- Local Institution
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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
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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:
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:
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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
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Every 30 days until MTD is reached
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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
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Every 8 weeks
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Evaluate safety and tolerability of the combination regimen
Time Frame: Ongoing
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Ongoing
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Assess effect of combination therapy on glucose metabolism
Time Frame: At 30 days, then every 8 weeks
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At 30 days, then every 8 weeks
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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
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Ongoing
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Obtain BMS-754807 plasma concentrations vs time data for future population PK analysis
Time Frame: Days, 1,8,15,22
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Days, 1,8,15,22
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
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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