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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00788333




Registration number
NCT00788333
Ethics application status
Date submitted
7/11/2008
Date registered
10/11/2008
Date last updated
13/07/2012

Titles & IDs
Public title
Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer
Scientific title
A Phase I/II Trial of BMS-754807 in Combination With Trastuzumab (Herceptin®) in Subjects With Advanced or Metastatic Her-2-positive Breast Cancer
Secondary ID [1] 0 0
EUDRACT #: 2009-013766-78
Secondary ID [2] 0 0
CA191-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-754807
Treatment: Drugs - trastuzumab (Herceptin®)

Experimental: A - Combination


Treatment: Drugs: 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

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Every 30 days until MTD is reached
Secondary outcome [1] 0 0
Assess anti-tumor activity of combination at MTD of BMS-754807 (dose expansion cohort)
Timepoint [1] 0 0
Every 8 weeks
Secondary outcome [2] 0 0
Evaluate safety and tolerability of the combination regimen
Timepoint [2] 0 0
Ongoing
Secondary outcome [3] 0 0
Assess effect of combination therapy on glucose metabolism
Timepoint [3] 0 0
At 30 days, then every 8 weeks
Secondary outcome [4] 0 0
Explore whether co-medication with oral anti-hyperglycemic agent can enable adequate tolerability of the combination therapy if BMS-754807 induces hyperglycemia
Timepoint [4] 0 0
Ongoing
Secondary outcome [5] 0 0
Obtain BMS-754807 plasma concentrations vs time data for future population PK analysis
Timepoint [5] 0 0
Days, 1,8,15,22

Eligibility
Key inclusion criteria
For additional information on this trial, please call (910) 558-2913



* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2011
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Kurralta Park
Recruitment hospital [2] 0 0
Local Institution - Frankston
Recruitment hospital [3] 0 0
Local Institution - Geelong
Recruitment postcode(s) [1] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Hungary
State/province [3] 0 0
Budapest
Country [4] 0 0
Hungary
State/province [4] 0 0
Miskolc
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Tyne And Wear

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00788333
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00788333