drugset / Trial / NCT00430846
Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2006-11
- Primary completion
- 2009-07
- Completion
- 2009-07
Publications
- Results 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brentuximab Vedotin | Monoclonal antibody | 0.1 mg/kg | — |
| Subject | Brentuximab Vedotin | Monoclonal antibody | 1.8 mg/kg | — |
| Subject | Brentuximab Vedotin | Monoclonal antibody | 3.6 mg/kg | — |