SCCA Clinical Studies: Phase 1 Program
SGN-35 for Lymphoma (UW 09043)
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
| Status | Conditions | Phase | Study ID |
| Closed | Hodgkin's Lymphoma, Large-Cell Anaplastic Lymphoma Non-Hodgkin's Lymphoma |
Phase 1 |
UW 09043 NCT01026415 |
Summary
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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Eligibility Criteria (must meet the following to participate in this study)
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adequate organ function (Special Populations: serum bilirubin >2 mg/dL or creatinine clearance <50 mL/min)
- ECOG performance status <2 (Special Populations: <3)
- Relapsed or refractory CD30-positive hematologic malignancy
Exclusion Criteria:
- Receiving prohibited medication within 4 weeks
- Poor liver function (Child-Pugh class C)
- Current diagnosis of of primary cutaneous ALCL
- Acute or chronic graft-versus-host disease
Last Updated
March 26, 2013See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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Please remember:
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.