A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study
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ClinicalTrials.gov Identifier: NCT00947856 |
Recruitment Status :
Completed
First Posted : July 28, 2009
Results First Posted : May 26, 2014
Last Update Posted : February 2, 2017
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Sponsor:
Seagen Inc.
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seagen Inc.
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Tracking Information | ||||
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First Submitted Date ICMJE | July 24, 2009 | |||
First Posted Date ICMJE | July 28, 2009 | |||
Results First Submitted Date ICMJE | March 21, 2014 | |||
Results First Posted Date ICMJE | May 26, 2014 | |||
Last Update Posted Date | February 2, 2017 | |||
Study Start Date ICMJE | July 2009 | |||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study | |||
Official Title ICMJE | Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study | |||
Brief Summary | This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study. | |||
Detailed Description | This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin (SGN-35) treatment in patients who previously participated in a brentuximab vedotin study, including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008 (NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if eligible. The study consisted of 2 arms, as follows:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: brentuximab vedotin
Every 3 weeks by IV infusion (1.2 or 1.8 mg/kg) until disease progression, unacceptable toxicity, or study closure
Other Name: Adcetris
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
110 | |||
Original Estimated Enrollment ICMJE |
50 | |||
Actual Study Completion Date ICMJE | March 2013 | |||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Withdrew consent to participate in any prior brentuximab vedotin study. |
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Sex/Gender ICMJE |
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Ages ICMJE | 6 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00947856 | |||
Other Study ID Numbers ICMJE | SGN35-006 2010-019932-11 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Seagen Inc. | |||
Original Responsible Party | Laurie Grove, PA-C, Seattle Genetics, Inc. | |||
Current Study Sponsor ICMJE | Seagen Inc. | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Millennium Pharmaceuticals, Inc. | |||
Investigators ICMJE |
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PRS Account | Seagen Inc. | |||
Verification Date | December 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |