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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
N/A
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/Phase 2
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/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
Other publications