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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005097-31 | EudraCT Number |
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To determine safety and maximum tolerated dose of brivanib alaninate when administered in combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel chemotherapy to subjects with advanced or metastatic solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Capecitabine + Brivanib alaninate) | Experimental |
| |
| Arm B (Doxorubicin + Brivanib alaninate) | Experimental |
| |
| Arm C (Ixabepilone + Brivanib alaninate) | Experimental |
| |
| Arm D (Docetaxel + Brivanib alaninate) | Experimental |
| |
| Arm E (Paclitaxel + Brivanib alaninate) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Tablets, Oral, Dose escalation to a MTD from a starting dose of 850 mg/m², twice a day (BID) x 14d per cycle, until disease progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine safety and the maximum tolerated dose of brivanib alaninate when administered in combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel chemotherapy to subjects with advanced or metastatic solid tumors | Every 21 days until the maximum tolerated dose (MTD) for each combination of brivanib is reached |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the anti-tumor activity of brivanib alaninate combination with the different chemotherapeutic regimens: capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel | Every 21 days | |
| To assess the effect each of capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel on the pharmacokinetics of BMS-540215 (active moiety of brivanib pro-drug) at the MTD |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
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 |
|---|---|---|---|---|---|---|
| Usc/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States | ||
| Dana Farber Cancer Institute |
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|
| Doxorubicin | Drug | IV, Dose escalation to a MTD from a starting dose of 40 mg/m², Q3wks, until disease progression |
|
|
| Ixabepilone | Drug | IV, Dose Escalation to a MTD from a starting dose of 32 mg/m², Q3wks, until disease progression |
|
|
| Docetaxel | Drug | IV, Dose escalation to an MTD from a starting dose of 60 mg/m², Q3wks, Until disease progression |
|
|
| Paclitaxel | Drug | IV, Dose escalation to an MTD from a starting dose of Paclitaxel 135 mg/m², Q3wks, Until disease progression |
|
|
| Brivanib alaninate | Drug | Tablets, Oral, Dose escalation to a MTD from a starting dose of 400 mg, daily (QD), until disease progression |
|
|
| Cycle 1D21, Days 1, 2, 3, 8 of Cycles 1 & 2 |
| To assess the effect of brivanib alaninate on the pharmacokinetics each of capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel chemotherapy regimens at the MTD | Cycle 1D21, Days 1, 2, 3, 8 of Cycles 1 & 2 |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Local Institution | Edmonton | Alberta | T6G 1Z2 | Canada |
| Local Institution | Toronto | Ontario | M5G 2M9 | Canada |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D004317 | Doxorubicin |
| C430592 | ixabepilone |
| D000077143 | Docetaxel |
| D017239 | Paclitaxel |
| C509922 | brivanib |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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