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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT #: 2008-004691-44 |
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The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental |
| |
| B2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-690514 | Drug | Tablets, Oral, 200 mg, once daily, Until disease progression or toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the progression-free survival of patients on BMS-690514 with those on erlotinib | CT/MRI at baseline and every 6 weeks for 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the overall survival between BMS-690514 and erlotinib | 15 months | |
| To estimate the overall response rate of BMS-690514 or erlotinib | 15 months | |
| To estimate the tumor size change and PFS rate at 6 weeks |
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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 |
|---|---|---|---|---|---|---|
| Yale University School Of Medicine | New Haven | Connecticut | 06520 | United States | ||
| Hematology Oncology, P.C. |
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| Erlotinib | Drug | Capsules, Oral, 150 mg, once daily, Until disease progression or toxicity |
|
|
| 6 weeks |
| To assess safety and tolerability of BMS-690514 and erlotinib | 15 months |
| To estimate the association between efficacy and EGFR copy as measured by FISH for both BMS-690514 and erlotinib | 15 months |
| To obtain samples for population pharmacokinetics for BMS-690514 in previously treated NSCLC patients | Days 1,8,15, 29 |
| Stamford |
| Connecticut |
| 06902-3628 |
| United States |
| Mass General Hospital | Boston | Massachusetts | 02114 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202-2689 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Piedmont Hematology Oncology Associates, Pllc | Winston-Salem | North Carolina | 27103 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Hema/Oncology Assoc. Of Nepa | Dunmore | Pennsylvania | 18512 | United States |
| Cancer Center Of The Carolinas | Greenville | South Carolina | 29605 | United States |
| Local Institution | Bahía Blanca | Buenos Aires | Argentina |
| Local Institution | Buenos Aires | Buenos Aires | Argentina |
| Local Institution | La Plata | Buenos Aires | 1900 | Argentina |
| Local Institution | Córdoba | Córdoba Province | X5000AAI | Argentina |
| Local Institution | La Rioja | La Rioja Province | 5300 | Argentina |
| Local Institution | Montreal | Quebec | H3T 1E2 | Canada |
| Local Institution | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Local Institution | Lyon | 69373 | France |
| Local Institution | Marseille | 13915 | France |
| Local Institution | Strasbourg | 67000 | France |
| Local Institution | Toulouse | 31052 | France |
| Local Institution | Villejuif | 94800 | France |
| Local Institution | Otwock | 05-400 | Poland |
| Local Institution | Gyeonggi-do | 410-769 | South Korea |
| Local Institution | Seoul | 135-710 | South Korea |
| Local Institution | Seoul | 138-736 | South Korea |
| Local Institution | Barcelona | 08035 | Spain |
| Local Institution | Madrid | 28046 | Spain |
| Local Institution | Vizcaya | 48903 | Spain |
| Local Institution | Taipei | 100 | Taiwan |
| Local Institution | Taipei | 112 | Taiwan |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C552150 | BMS-690514 |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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