NCT00649584

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

A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	SGN-35	IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles
DRUG	gemcitabine	IV; 1000 mg/m2 weekly 3 out of 4 weeks

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2008-04-01
• Last updated: 2014-12-18

Locations

5 sites across 1 country: United States