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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00649584
• Other study ID #: SG035-0002
• Status: Terminated
• Phase: Phase 1
• First received: March 27, 2008
• Last updated: December 17, 2014
• Start date: March 2008
• Est. completion date: February 2010

Study information

• Verified date: December 2014
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• SGN-35
IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles
• gemcitabine
IV; 1000 mg/m2 weekly 3 out of 4 weeks

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of Miami	Miami	Florida
United States	Stanford University Medical Center	Palo Alto	California
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 R — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events and laboratory abnormalities		1 month after last dose	Yes
Secondary	PK profile		2 months after last dose	No
Secondary	Immunogenicity (anti-SGN-35 antibodies)		1 month after last dose	Yes
Secondary	Anti-tumor activity		1 month after last dose	No