Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00788333
First received: November 7, 2008
Last updated: July 12, 2012
Last verified: July 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: BMS-754807 Drug: trastuzumab (Herceptin®) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Trastuzumab
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Assess anti-tumor activity of combination at MTD of BMS-754807 (dose expansion cohort) [ Time Frame: Every 8 weeks ] [ Designated as safety issue: Yes ]
- Evaluate safety and tolerability of the combination regimen [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
- Assess effect of combination therapy on glucose metabolism [ Time Frame: At 30 days, then every 8 weeks ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Obtain BMS-754807 plasma concentrations vs time data for future population PK analysis [ Time Frame: Days, 1,8,15,22 ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | July 2009 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00788333 History of Changes |
| Other Study ID Numbers: | CA191-004, EUDRACT #: 2009-013766-78 |
| Study First Received: | November 7, 2008 |
| Last Updated: | July 12, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Ministry of Health & Long Term Care, Ontario Hungary: Ministry of Health United Kingdom: National Institute for Health and Clinical Excellence |
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 Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013