NCT01026233CompletedPhase 1
An Intensive QT/QTc Study to Investigate the Effects of SGN-35 (Brentuximab Vedotin) on Cardiac Ventricular Repolarization in Patients With CD30-Positive Malignancies
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Seagen Inc.
- Enrollment
- 52
- Locations
- 9
- Primary Endpoint
- QTc interval
Study Overview
Brief Summary
The purpose of this study is to evaluate cardiac safety of brentuximab vedotin (SGN-35) in patients with CD30-positive cancers. The study will assess electrical activity of the heart before and after brentuximab vedotin administration. Patients who have stable or improving disease may receive up to 1 year of brentuximab vedotin treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Relapsed or refractory CD30-positive malignancy
- •Adequate organ function
- •ECOG performance status <2
Exclusion Criteria
- •Cardiac abnormalities (abnormal rhythm, history of significant cardiac event)
- •Current diagnosis of primary cutaneous ALCL
- •Acute or chronic graft-versus-host disease
- •Prior hematopoietic stem cell transplant within specified timeframe
Arms & Interventions
1
Experimental
brentuximab vedotin
Intervention: brentuximab vedotin (Drug)
Outcomes
Primary Outcomes
QTc interval
Time Frame: 2-4 days postdose
Secondary Outcomes
- Blood MMAE levels(Through 4 days postdose)
- ECG parameters(2-4 days postdose)
- Incidence of proarrhythmic adverse events(Through 1 month following last dose)
- Incidence of adverse events and laboratory abnormalities(Through 1 month following last dose)
Investigators
Study Sites (9)
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