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| Name | Class |
|---|---|
| Millennium Pharmaceuticals, Inc. | INDUSTRY |
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The purpose of this study is to identify brentuximab vedotin drug-drug interactions in patients with CD30-positive cancers and to determine the main route of excretion. The study will also assess blood drug levels in patients with renal or hepatic impairment (special populations).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | midazolam +/- brentuximab vedotin |
|
| 2 | Experimental | brentuximab vedotin +/- rifampin |
|
| 3 | Experimental | brentuximab vedotin +/- ketoconazole |
|
| 4 | Experimental | special populations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brentuximab vedotin | Drug | 1.8 mg/kg IV every 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Midazolam blood concentrations +/- brentuximab vedotin | 3 weeks | |
| Brentuximab vedotin blood concentrations +/- rifampin | 6 weeks | |
| Brentuximab vedotin in urine, feces, and blood | 1 week | |
| Brentuximab vedotin blood concentrations in special populations | 3 weeks | |
| Brentuximab vedotin blood concentrations +/- ketoconazole | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and laboratory abnormalities | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Manley, MD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Colorado Blood Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23754575 | Result | Han TH, Gopal AK, Ramchandren R, Goy A, Chen R, Matous JV, Cooper M, Grove LE, Alley SC, Lynch CM, O'Connor OA. CYP3A-mediated drug-drug interaction potential and excretion of brentuximab vedotin, an antibody-drug conjugate, in patients with CD30-positive hematologic malignancies. J Clin Pharmacol. 2013 Aug;53(8):866-77. doi: 10.1002/jcph.116. Epub 2013 Jun 10. | |
| 22510871 |
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| rifampin | Drug | 600 mg/day PO |
|
| midazolam | Drug | 1 mg IV |
|
| ketoconazole | Drug | 400 mg/day PO |
|
| brentuximab vedotin | Drug | 1.2 mg/kg IV every 21 days |
|
|
| Denver |
| Colorado |
| 80218 |
| United States |
| St. Francis Medical Group Oncology & Hematology Specialists | Indianapolis | Indiana | 46237 | United States |
| Karmanos Cancer Institute / Wayne State University | Detroit | Michigan | 48209 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Seattle Cancer Care Alliance / University of Washington Medical Center | Seattle | Washington | 98109-1023 | United States |
| Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. doi: 10.1182/blood-2011-12-397893. Epub 2012 Apr 17. |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D006689 | Hodgkin Disease |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D008228 | Lymphoma, Non-Hodgkin |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016399 | Lymphoma, T-Cell |
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| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| D012293 | Rifampin |
| D008874 | Midazolam |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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