Clinical trial · Interventional
Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)
An Open-Label Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35) in Patients With CD30-Positive Hematologic Malignancies: CYP3A4 Drug-Drug Interactions, Excretion, and Special Populations
NCT01026415CI-TRIAL-00016375completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinomas | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Disease, Hodgkin | Hodgkin Lymphoma | ALIAS | 0.90 |
| Lymphoma, Large-Cell, Anaplastic | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brentuximab vedotin | Drug | Brentuximab Vedotin | ALIAS |
| ketoconazole | Drug | — | UNRESOLVED |
| midazolam | Drug | — | UNRESOLVED |
| rifampin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1
- description
- midazolam +/- brentuximab vedotin
- interventionNames
- Drug: brentuximab vedotin
- Drug: midazolam
- type
- EXPERIMENTAL
- label
- 2
- description
- brentuximab vedotin +/- rifampin
- interventionNames
- Drug: brentuximab vedotin
- Drug: rifampin
- type
- EXPERIMENTAL
- label
- 3
- description
- brentuximab vedotin +/- ketoconazole
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adequate organ function (Special Populations: serum bilirubin \>2 mg/dL or creatinine clearance \<50 mL/min) * ECOG performance status \<2 (Special Populations: \<4) * Relapsed or refractory CD30-positive malignancy Exclusion Criteria: * Receiving prohibited medication within 4 weeks * Poor liver function (Child-Pugh class C) * Current diagnosis of primary cutaneous ALCL * Acute or chronic graft-versus-host disease
References
Publications (2)
- RESULTHan 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. PMID 23754575
- DERIVEDGopal 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. PMID 22510871