A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Collaborator: Millennium Pharmaceuticals, Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Brentuximab Vedotin

Criteria

Inclusion Criteria:

• Participated in either the SGN35-005 or C25001 clinical study and experienced progression. Patients who received brentuximab vedotin in C25001 must have had an objective response at the time of discontinuation.

• Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin

Exclusion Criteria:

• History of another primary malignancy that has not been in remission for at least 3 years

• Known cerebral/meningeal disease

• Peripheral neuropathy of grade 2 or greater

• Females who are pregnant or breastfeeding