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|
Recruitment Status : Available
First Posted : September 8, 2010
Last Update Posted : September 11, 2017
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
|First Submitted Date||September 3, 2010|
|First Posted Date||September 8, 2010|
|Last Update Posted Date||September 11, 2017|
|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.
|Expanded Access Status||Available|
|Listed Location Countries||Australia, Belgium, Bulgaria, France, Germany, Hungary, Italy, Poland, Romania, Russian Federation, Serbia, Spain, Switzerland, United Kingdom, United States|
|Removed Location Countries|
|Responsible Party||Seattle Genetics, Inc.|
|Study Sponsor||Seattle Genetics, Inc.|
|Collaborators||Millennium Pharmaceuticals, Inc.|
|PRS Account||Seattle Genetics, Inc.|
|Verification Date||September 2017|