Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

A Phase I Dose Escalation Study of SGN-35 in Patients With Relapsed/Refractory CD30-Positive Hematologic Malignancies.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430846
• Other study ID #: SG035-0001
• Status: Completed
• Phase: Phase 1
• First received: February 1, 2007
• Last updated: December 17, 2014
• Start date: November 2006
• Est. completion date: July 2009

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

Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies. This is a single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.

Other known NCT identifiers

• NCT00412282

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have histologically confirmed CD30-positive hematologic malignancy.

• Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant.

• Patients must have measurable disease of at least 10mm as documented by radiographic technique.

• Must be at least 18 years of age.

Exclusion Criteria:

• Patients with current diagnosis of pcALCL (systemic ALCL eligible).

• Patients with 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
Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg

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	Weill Cornell Medical College	New York	New York
United States	Washington University	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Younes A, Bartlett NL, Leonard JP, Kennedy DA, Lynch CM, Sievers EL, Forero-Torres A. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med. 2010 Nov 4;363(19):1812-21. doi: 10.1056/NEJMoa1002965. — 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

External Links

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