Clinical trial NCT00788333: Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: Advanced or Metastatic Her-2-positive Breast Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-11-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Every 30 days until MTD is reached
Secondary outcomes:
measure: Assess anti-tumor activity of combination at MTD of BMS-754807 (dose expansion cohort)
timeFrame: Every 8 weeks
measure: Evaluate safety and tolerability of the combination regimen
timeFrame: Ongoing
measure: Assess effect of combination therapy on glucose metabolism
timeFrame: At 30 days, then every 8 weeks
measure: Explore whether co-medication with oral anti-hyperglycemic agent can enable adequate tolerability of the combination therapy if BMS-754807 induces hyperglycemia
timeFrame: Ongoing
measure: Obtain BMS-754807 plasma concentrations vs time data for future population PK analysis
timeFrame: Days, 1,8,15,22
Other outcomes:
Locations:
city: Kurralta Park
country: Australia
facility: Local Institution
state: South Australia
city: Frankston
country: Australia
facility: Local Institution
state: Victoria
city: Geelong
country: Australia
facility: Local Institution
state: Victoria
city: Brussels
country: Belgium
facility: Local Institution
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Budapest
country: Hungary
facility: Local Institution
city: Miskolc
country: Hungary
facility: Local Institution
city: Newcastle Upon Tyne
country: United Kingdom
facility: Local Institution
state: Tyne And Wear
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: