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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022727-29 | EudraCT Number |
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The purpose of this study is to identify a safe and tolerable dose of BMS-906024, either alone or in combination with Dexamethasone in subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma who no longer respond to or have relapsed from standard therapies
Minimum Age: 10 years and older at selected sites
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escalation Phase: BMS-906024 | Experimental | BMS-906024 escalating doses starting at 0.3 mg solution for intravenous (IV) administration once weekly continuously until disease progression or unacceptable toxicity |
|
| Expansion Phase: BMS-906024 + Dexamethasone | Experimental | BMS-906024 maximum tolerated dose (To be determined) solution for IV administration once weekly and Dexamethasone 20mg/day tablet by mouth (Oral) for 3-4 days every week for 3-4 weeks per cycle continuously until disease progression or unacceptable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-906024 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events as a measure of safety and tolerability | Weekly assessments until study discontinuation due to disease progression or unacceptable adverse events as well as an assessment 30 days after treatment discontinuation with an average time on study expected to be < 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease assessments in bone marrow & by computed tomography (CT)/ magnetic resonance imaging (MRI) | Disease assessments at least every 8 weeks during treatment | |
| Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: maximum observed concentration (Cmax) |
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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 |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| Memorial Sloan Kettering Cancer Center |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| Dexamethasone | Drug |
|
|
| Pharmacokinetics at multiple time points during the first 4 weeks of dosing |
| Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: minimum observed concentration (Cmin) | Pharmacokinetics at multiple time points during the first 4 weeks of dosing |
| Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: area under the concentration-time curve (AUC) | Pharmacokinetics at multiple time points during the first 4 weeks of dosing |
| Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: time to reach maximum observed concentration (Tmax) | Pharmacokinetics at multiple time points during the first 4 weeks of dosing |
| Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: terminal phase elimination half-life (T-Half) | Pharmacokinetics at multiple time points during the first 4 weeks of dosing |
| Pharmacokinetics of BMS-906024 and its metabolite BMS-911557: accumulation index (ratio of AUC at steady state to AUC after first dose) | Pharmacokinetics at multiple time points during the first 4 weeks of dosing |
| Pharmacodynamics (percent change from baseline in mRNA expression of Notch pathway-related genes in blood cells) | Pharmacodynamic sampling: in blood during the first 8 weeks of dosing |
| New York |
| New York |
| 10065 |
| United States |
| The University Of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
| Local Institution | Marseille | 13273 | France |
| Local Institution | Paris | 75475 | France |
| Johann Wolfgang Goethe Universitaet | Frankfurt am Main | 60590 | Germany |
| ID | Term |
|---|---|
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000606543 | BMS-906024 |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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