Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies

Phase 1

Completed

• Conditions: Disease, Hodgkin; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin
• Interventions: Drug: SGN-35

• Registration Number: NCT00430846
• Lead Sponsor: Seagen Inc.

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

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-02-01
• Study First Submitted QC: 2007-02-01
• Study First Posted: 2007-02-02
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	SGN-35	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events and laboratory abnormalities	1 month after last dose

Secondary Outcome Measures

Name	Time	Method
PK profile	2 months after last dose
Immunogenicity (anti-SGN-35 antibodies)	1 month after last dose
Anti-tumor activity	1 month after last dose

Trial Locations

Locations (4)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Washington University; 🇺🇸 St. Louis, Missouri, United States

University of Texas/MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States