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

Stopped early · Phase 1

Conditions studied: Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin

In brief

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.

Key facts

Study ID

NCT00649584

Run by

Seagen Inc.

People needed

44

Starts

2008-03-01

Expected to finish

2010-02-01

Last updated by the study team

2014-12-18

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Stanford University Medical Center — Palo Alto, California, United States
• University of Miami — Miami, Florida, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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