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Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies. This is a single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGN-35 | Drug | Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and laboratory abnormalities | 1 month after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK profile | 2 months after last dose | |
| Immunogenicity (anti-SGN-35 antibodies) | 1 month after last dose | |
| Anti-tumor activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andres Forero, MD | University of Alabama at Birmingham | Principal Investigator |
| Anas Younes, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Nancy Bartlett, MD | Washington University School of Medicine | Principal Investigator |
| John Leonard, MD | Weill Medical College of Cornell University | Principal Investigator |
| Dana Kennedy, PharmD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Washington University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21047225 | Result | Younes A, Bartlett NL, Leonard JP, Kennedy DA, Lynch CM, Sievers EL, Forero-Torres A. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med. 2010 Nov 4;363(19):1812-21. doi: 10.1056/NEJMoa1002965. | |
| 32596842 | Derived | Suri A, Mould DR, Song G, Kinley J, Venkatakrishnan K. Population Pharmacokinetics of Brentuximab Vedotin in Adult and Pediatric Patients With Relapsed/Refractory Hematologic Malignancies: Model-Informed Hypothesis Generation for Pediatric Dosing Regimens. J Clin Pharmacol. 2020 Dec;60(12):1585-1597. doi: 10.1002/jcph.1682. Epub 2020 Jun 28. |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D006402 | Hematologic Diseases |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
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| 1 month after last dose |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| University of Texas/MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016399 | Lymphoma, T-Cell |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |