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Brief Title: Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies
Official Title: A Phase I Dose Escalation Study of SGN-35 in Patients With Relapsed/Refractory CD30-Positive Hematologic Malignancies.
Study ID: NCT00430846
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Washington University, St. Louis, Missouri, United States
Weill Cornell Medical College, New York, New York, United States
University of Texas/MD Anderson Cancer Center, Houston, Texas, United States
Name: Andres Forero, MD
Affiliation: University of Alabama at Birmingham
Role: PRINCIPAL_INVESTIGATOR
Name: Anas Younes, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Nancy Bartlett, MD
Affiliation: Washington University School of Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: John Leonard, MD
Affiliation: Weill Medical College of Cornell University
Role: PRINCIPAL_INVESTIGATOR
Name: Dana Kennedy, PharmD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR