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

Sponsor

Seagen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00430846

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

11.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic	Drug: SGN-35	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: SGN-35 Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg Other Names: brentuximab vedotin

Arm

Intervention/Treatment

Experimental: A

Drug: SGN-35

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

Other Names:

brentuximab vedotin

Outcome Measures

Primary Outcome Measures

Incidence of adverse events and laboratory abnormalities [1 month after last dose]

Secondary Outcome Measures

PK profile [2 months after last dose]
Immunogenicity (anti-SGN-35 antibodies) [1 month after last dose]
Anti-tumor activity [1 month after last dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Washington University	St. Louis	Missouri	United States	63110
3	Weill Cornell Medical College	New York	New York	United States	10021
4	University of Texas/MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

Seagen Inc.

Investigators

Principal Investigator: Andres Forero, MD, University of Alabama at Birmingham
Principal Investigator: Anas Younes, MD, M.D. Anderson Cancer Center
Principal Investigator: Nancy Bartlett, MD, Washington University School of Medicine
Principal Investigator: John Leonard, MD, Weill Medical College of Cornell University
Study Director: Dana Kennedy, PharmD, Seagen Inc.