NCT00430846

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

A Phase I Dose Escalation Study of SGN-35 in Patients With Relapsed/Refractory CD30-Positive Hematologic Malignancies.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, Non-Hodgkin
• Disease, Hodgkin
• Lymphoma, Large-Cell, Anaplastic

Interventions

Type	Name	Description
DRUG	SGN-35	Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2007-02-02
• Last updated: 2014-12-18

Locations

4 sites across 1 country: United States