Overview

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

Status:
Terminated
Trial end date:
2010-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seagen Inc.
Seattle Genetics, Inc.
Treatments:
Antibodies
Brentuximab Vedotin
Gemcitabine
Criteria
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.