- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00430846
Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies
December 17, 2014 updated by: Seagen Inc.
A Phase I Dose Escalation Study of SGN-35 in Patients With Relapsed/Refractory CD30-Positive Hematologic Malignancies.
Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.
This is a single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University
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New York
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New York, New York, United States, 10021
- Weill Cornell Medical College
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Texas
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Houston, Texas, United States, 77030
- University of Texas/MD Anderson Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have histologically confirmed CD30-positive hematologic malignancy.
- Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant.
- Patients must have measurable disease of at least 10mm as documented by radiographic technique.
- Must be at least 18 years of age.
Exclusion Criteria:
- Patients with current diagnosis of pcALCL (systemic ALCL eligible).
- Patients with history of allogeneic stem cell transplant.
- Patients who have had previous treatment with any anti-CD30 antibody.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
|
Every 21 days.
Dose Escalating.
0.1 - 3.6 mg/kg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events and laboratory abnormalities
Time Frame: 1 month after last dose
|
1 month after last dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PK profile
Time Frame: 2 months after last dose
|
2 months after last dose
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Immunogenicity (anti-SGN-35 antibodies)
Time Frame: 1 month after last dose
|
1 month after last dose
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Anti-tumor activity
Time Frame: 1 month after last dose
|
1 month after last dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anas Younes, MD, M.D. Anderson Cancer Center
- Principal Investigator: Andres Forero, MD, University of Alabama at Birmingham
- Principal Investigator: Nancy Bartlett, MD, Washington University School of Medicine
- Principal Investigator: John Leonard, MD, Weill Medical College of Cornell University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Suri A, Mould DR, Song G, Kinley J, Venkatakrishnan K. Population Pharmacokinetics of Brentuximab Vedotin in Adult and Pediatric Patients With Relapsed/Refractory Hematologic Malignancies: Model-Informed Hypothesis Generation for Pediatric Dosing Regimens. J Clin Pharmacol. 2020 Dec;60(12):1585-1597. doi: 10.1002/jcph.1682. Epub 2020 Jun 28.
- Younes A, Bartlett NL, Leonard JP, Kennedy DA, Lynch CM, Sievers EL, Forero-Torres A. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med. 2010 Nov 4;363(19):1812-21. doi: 10.1056/NEJMoa1002965.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
February 1, 2007
First Submitted That Met QC Criteria
February 1, 2007
First Posted (Estimate)
February 2, 2007
Study Record Updates
Last Update Posted (Estimate)
December 18, 2014
Last Update Submitted That Met QC Criteria
December 17, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Hematologic Diseases
- Lymphoma, T-Cell
- Lymphoma
- Hematologic Neoplasms
- Hodgkin Disease
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Anaplastic
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Brentuximab Vedotin
Other Study ID Numbers
- SG035-0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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