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

Seagen

Status and phase: Terminated; Phase 1

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

Treatments: Drug: gemcitabine; Drug: SGN-35

Study type: Interventional

Funder types: Industry

Identifiers

NCT00649584

SG035-0002

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

44 participants in 1 patient group

1

Experimental group

Description:

SGN-35 alone or in combination with gemcitabine

Treatment:

Drug: SGN-35

Drug: gemcitabine