A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy. |
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Condition | Disease, Hodgkin |
Intervention | Drug: brentuximab vedotin Drug: doxorubicin Drug: vinblastine Drug: dacarbazine Drug: bleomycin Drug: brentuximab vedotin |
Phase | Phase 1 |
Sponsor | Seattle Genetics, Inc. |
Responsible Party | Seattle Genetics, Inc. |
ClinicalTrials.gov Identifier | NCT01060904 |
First Received | January 29, 2010 |
Last Updated | November 7, 2012 |
Last verified | November 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | January 29, 2010 |
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Last Updated Date | November 7, 2012 |
Start Date | January 2010 |
Estimated Primary Completion Date | September 2012 |
Current Primary Outcome Measures | Incidence of adverse events and laboratory abnormalities [Time Frame: Through 1 month after last dose] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma |
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Official Title | A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma |
Brief Summary | The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Disease, Hodgkin |
Intervention | Drug: brentuximab vedotin 0.6-1.2 mg/kg IV every 2 weeks Other Names: SGN-35Drug: doxorubicin 25 mg/m2 IV every 2 weeks Drug: vinblastine 6 mg/m2 IV every 2 weeks Drug: dacarbazine 375 mg/m2 IV every 2 weeks Drug: bleomycin 10 units/m2 IV every 2 weeks Drug: brentuximab vedotin 0.9-1.2 mg/kg IV every 2 weeks Other Names: SGN-35 |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 51 |
Estimated Completion Date | September 2012 |
Estimated Primary Completion Date | September 2012 |
Eligibility Criteria | Inclusion Criteria: - Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV - Measurable disease of at least 1.5 cm - Eastern Cooperative Oncology Group performance status <3 Exclusion Criteria: - History of another primary malignancy that has not been in remission for at least 3 years - Known cerebral/meningeal disease |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Canada |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01060904 |
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Other Study ID Numbers | SGN35-009 |
Has Data Monitoring Committee | No |
Information Provided By | Seattle Genetics, Inc. |
Study Sponsor | Seattle Genetics, Inc. |
Collaborators | Millennium Pharmaceuticals, Inc. |
Investigators | Study Director: Naomi Hunder, MD Seattle Genetics, Inc. |
Verification Date | November 2012 |
Locations[ + expand ][ + ]
Mayo Clinic | Rochester, Minnesota, United States, 55905 |
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UNC Lineberger Comprehensive Cancer Center / University of North Carolina | Chapel Hill, North Carolina, United States, 27599 |
MD Anderson Cancer Center / University of Texas | Houston, Texas, United States, 77030 |
British Columbia Cancer Agency - Vancouver Centre | Vancouver, British Columbia, Canada, V5Z 4E6 |