A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies

Phase 1

Terminated

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

• Registration Number: NCT00649584
• Lead Sponsor: Seagen Inc.

Brief Summary

This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-27
• Study First Submitted QC: 2008-03-27
• Study First Posted: 2008-04-01
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Histologically confirmed CD30-positive hematologic malignancy.
• Patients with HL must have failed systemic chemotherapy.
• Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.
• Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique.

Exclusion Criteria

• Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).
• 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
1	gemcitabine	SGN-35 alone or in combination with gemcitabine
1	SGN-35	SGN-35 alone or in combination with gemcitabine

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 (5)

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

University of Miami; 🇺🇸 Miami, Florida, United States

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

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

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