Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
1 other identifier
interventional
84
1 country
29
Brief Summary
This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2011
Typical duration for phase_2
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 24, 2011
CompletedFirst Posted
Study publicly available on registry
October 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
March 4, 2016
CompletedMarch 4, 2016
February 1, 2016
3.2 years
October 24, 2011
December 18, 2015
February 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) by Investigator
Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).
Up to approximately 3 years
Secondary Outcomes (11)
Complete Remission (CR) Rate by Investigator
Up to approximately 3 years
Duration of Objective Response by Kaplan-Meier Analysis
Up to approximately 2 years
Duration of Complete Response by Kaplan-Meier Analysis
Up to approximately 2 years
Progression-Free Survival by Kaplan-Meier Analysis
Up to approximately 2 years
Adverse Events by Severity, Seriousness, and Relationship to Treatment
Up to approximately 3 years
- +6 more secondary outcomes
Study Arms (3)
Brentuximab vedotin 1.8 mg/kg
EXPERIMENTALBrentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Brentuximab vedotin 2.4 mg/kg
EXPERIMENTALBrentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion
Brentuximab vedotin 1.2 mg/kg
EXPERIMENTALBrentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion
Interventions
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Eligibility Criteria
You may qualify if:
- Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy
- Have failed, refused, or have been deemed ineligible for standard therapy
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70
You may not qualify if:
- Primary diagnosis of lymphoma or central nervous system (CNS) malignancy
- History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years
- Evidence of active cerebral/meningeal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
Study Sites (29)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300, United States
City of Hope
Duarte, California, 91010-3000, United States
PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists
Oxnard, California, 93030, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, 80012, United States
Mayo Clinic Cancer Center
Jacksonville, Florida, 32224, United States
Ocala Oncology Center
Ocala, Florida, 34471, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Minnesota Oncology Hematology P.A.
Minneapolis, Minnesota, 55404, United States
New York Oncology Hematology, P.C.
Albany, New York, 12206, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106-5055, United States
Willamette Valley Cancer and Research / USOR
Eugene, Oregon, 97401, United States
Northwest Cancer Specialists, P.C.
Tulatin, Oregon, 97062, United States
St. Francis Hospital
Greenville, South Carolina, 29605, United States
Texas Oncology - Bedford
Bedford, Texas, 76022, United States
Texas Oncology - Medical City Dallas
Dallas, Texas, 75230, United States
Texas Oncology - Dallas Presbyterian
Dallas, Texas, 75231, United States
Texas Oncology Denton South
Denton, Texas, 76210, United States
Texas Oncology - Fort Worth 12th Avenue
Fort Worth, Texas, 76104, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, 77030-4003, United States
MD Anderson Cancer Center Leukemia Group
Houston, Texas, 77030, United States
Texas Oncology - Central Austin Cancer Center
Round Rock, Texas, 78731, United States
Cancer Centers of South Texas - HOAST
San Antonio, Texas, 78229, United States
Texas Oncology - Waco
Waco, Texas, 76712, United States
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Puget Sound Cancer Centers
Edmonds, Washington, 98026, United States
Cancer Care Northwest
Spokane Valley, Washington, 99216, United States
Yakima Valley Memorial Hospital / North Star Lodge
Yakima, Washington, 98902, United States
Related Publications (3)
Albany C, Einhorn L, Garbo L, Boyd T, Josephson N, Feldman DR. Treatment of CD30-Expressing Germ Cell Tumors and Sex Cord Stromal Tumors with Brentuximab Vedotin: Identification and Report of Seven Cases. Oncologist. 2018 Mar;23(3):316-323. doi: 10.1634/theoncologist.2017-0544. Epub 2017 Dec 8.
PMID: 29222199DERIVEDBorate U, Mehta A, Reddy V, Tsai M, Josephson N, Schnadig I. Treatment of CD30-positive systemic mastocytosis with brentuximab vedotin. Leuk Res. 2016 May;44:25-31. doi: 10.1016/j.leukres.2016.02.010. Epub 2016 Feb 27.
PMID: 26994848DERIVEDGiannatempo P, Paolini B, Miceli R, Raggi D, Nicolai N, Fare E, Catanzaro M, Biasoni D, Torelli T, Stagni S, Piva L, Mariani L, Salvioni R, Colecchia M, Gianni AM, Necchi A. Persistent CD30 expression by embryonal carcinoma in the treatment time course: prognostic significance of a worthwhile target for personalized treatment. J Urol. 2013 Nov;190(5):1919-24. doi: 10.1016/j.juro.2013.04.057. Epub 2013 Apr 25.
PMID: 23624209DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Office
- Organization
- Seattle Genetics, Inc.
Study Officials
- STUDY DIRECTOR
Neil Josephson, MD
Seagen Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2011
First Posted
October 28, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
March 4, 2016
Results First Posted
March 4, 2016
Record last verified: 2016-02