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

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ClinicalTrials.gov Identifier: NCT01196208

Expanded Access Status : No longer available

First Posted : September 8, 2010

Last Update Posted : September 21, 2020

Sponsor:

Collaborator:

Millennium Pharmaceuticals, Inc.

Information provided by (Responsible Party):

Seagen Inc.

Tracking Information

First Submitted Date

September 3, 2010

First Posted Date

September 8, 2010

Last Update Posted Date

September 21, 2020

Descriptive Information

Brief Title

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

Brief Summary

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

Detailed Description

The protocol was amended to reflect the change from a phase 2/3 to a study with an expanded access program (EAP) in the US that would include patients with ALCL and HL. A later amendment allowed patients with CD30-positive cutaneous T-cell lymphoma to enroll. Enrollment may continue and patients may receive brentuximab vedotin treatment on study until the drug is commercially approved and available to patients in a geographic region.

Study Type

Expanded Access

Intervention

Drug: brentuximab vedotin

Every 21 days by intravenous infusion (1.8 mg/kg)

Other Name: SGN-35

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Expanded Access Status

No longer available

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

Australia, Belgium, Bulgaria, France, Germany, Hungary, Italy, Poland, Romania, Russian Federation, Serbia, Spain, Switzerland, United Kingdom, United States

Removed Location Countries

Administrative Information

NCT Number

NCT01196208

Responsible Party

Seagen Inc.

Study Sponsor

Seagen Inc.

Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

Study Director:

Liga Ulmane, MD

PSI Company Ltd.

PRS Account

Seagen Inc.

Verification Date

September 2020

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