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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT #: 2009-013766-78 |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-754807 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Every 30 days until MTD is reached |
| Measure | Description | Time Frame |
|---|---|---|
| Assess anti-tumor activity of combination at MTD of BMS-754807 (dose expansion cohort) | Every 8 weeks | |
| Evaluate safety and tolerability of the combination regimen | Ongoing | |
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For additional information on this trial, please call (910) 558-2913
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Kurralta Park | South Australia | 5037 | Australia | ||
| Local Institution |
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|
| trastuzumab (Herceptin®) | Drug | 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 |
|
|
| Assess effect of combination therapy on glucose metabolism |
| At 30 days, then every 8 weeks |
| Explore whether co-medication with oral anti-hyperglycemic agent can enable adequate tolerability of the combination therapy if BMS-754807 induces hyperglycemia | Ongoing |
| Obtain BMS-754807 plasma concentrations vs time data for future population PK analysis | Days, 1,8,15,22 |
| Frankston |
| Victoria |
| 3199 |
| Australia |
| Local Institution | Geelong | Victoria | 3220 | Australia |
| Local Institution | Brussels | 1000 | Belgium |
| Local Institution | Ottawa | Ontario | K1H 8L6 | Canada |
| Local Institution | Toronto | Ontario | M5G 1X5 | Canada |
| Local Institution | Budapest | 1122 | Hungary |
| Local Institution | Miskolc | 3526 | Hungary |
| Local Institution | Newcastle upon Tyne | Tyne and Wear | NE7 7DN | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C545990 | BMS 754807 |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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