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

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ClinicalTrials.gov Identifier: NCT00788333
Recruitment Status : Completed
First Posted : November 10, 2008
Last Update Posted : July 13, 2012
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: BMS-754807 Drug: trastuzumab (Herceptin®) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Combination
Drug: 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
Other Name: IGF-IR
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
Other Name: Herceptin®



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Assess anti-tumor activity of combination at MTD of BMS-754807 (dose expansion cohort) [ Time Frame: Every 8 weeks ]
  2. Evaluate safety and tolerability of the combination regimen [ Time Frame: Ongoing ]
  3. Assess effect of combination therapy on glucose metabolism [ Time Frame: At 30 days, then every 8 weeks ]
  4. 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 ]
  5. Obtain BMS-754807 plasma concentrations vs time data for future population PK analysis [ Time Frame: Days, 1,8,15,22 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788333


Locations
Australia, South Australia
Local Institution
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Local Institution
Frankston, Victoria, Australia, 3199
Local Institution
Geelong, Victoria, Australia, 3220
Belgium
Local Institution
Brussels, Belgium, 1000
Canada, Ontario
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
Local Institution
Toronto, Ontario, Canada, M5G 1X5
Hungary
Local Institution
Budapest, Hungary, 1122
Local Institution
Miskolc, Hungary, 3526
United Kingdom
Local Institution
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00788333     History of Changes
Other Study ID Numbers: CA191-004
EUDRACT #: 2009-013766-78
First Posted: November 10, 2008    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012

Keywords provided by Bristol-Myers Squibb:
Advanced or Metastatic Her-2-positive Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents