Clinical trial NCT00430846: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma, Non-Hodgkin
Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Keywords: Antigens,CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Lymphoma, Non-Hodgkin
Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Hematologic Diseases
Lymphoma
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2007-02-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse events and laboratory abnormalities
timeFrame: 1 month after last dose
Secondary outcomes:
measure: PK profile
timeFrame: 2 months after last dose
measure: Immunogenicity (anti-SGN-35 antibodies)
timeFrame: 1 month after last dose
measure: Anti-tumor activity
timeFrame: 1 month after last dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Houston
country: United States
facility: University of Texas/MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: University of Alabama at Birmingham
name: Andres Forero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D. Anderson Cancer Center
name: Anas Younes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Nancy Bartlett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: John Leonard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seagen Inc.
name: Dana Kennedy, PharmD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.