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

Phase 1 Terminated 44 enrolled Seagen Inc.

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2008-03
Primary completion: 2010-02
Completion: 2010-02

Publications

Results Fanale MA, Forero-Torres A, Rosenblatt JD, Advani RH, Franklin AR, Kennedy DA, Han TH, Sievers EL, Bartlett NL. A phase I weekly dosing study of brentuximab vedotin in patients with relapsed/refractory CD30-positive hematologic malignancies. Clin Cancer Res. 2012 Jan 1;18(1):248-55. doi: 10.1158/1078-0432.CCR-11-1425. Epub 2011 Nov 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brentuximab Vedotin	Monoclonal antibody	0.4 mg/kg	—
Subject	Brentuximab Vedotin	Monoclonal antibody	1.8 mg/kg	—
Subject	Gemcitabine	Small molecule	1000 mg/m2	—

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

Summary

Timeline

Publications

Drugs

Indications